Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Viatris Inc

Viatris Inc
HQ: Canonsburg, United States • Ticker: VTRS • Stock exchange: NASDAQ • Nr. of employees: 38,000

CO M PANY SU M MARY
Viatris expands access to its products through its broad off-patent medicine portfolio, geographic footprint spanning over 70% of countries in scope, and global
supply network. Some of the company’s access commitments are supported bymeasurable and time-bound objectives, including its goal to reach 30 million HIV/AIDS patients with antiretroviral therapies by 2025. Viatris files products widely forregistration and has filed or registered the ten assessed products in a high numberof low-income countries. Viatris expands access to its products through supranational procurement, government tenders and public partnerships. It also employs
free pricing and competitor-based pricing strategies for its products sold in theprivate sector. Moreover, it presents evidence of tailoring some of its pricing strategies to payers’ ability to pay. As a sublicensee for treatments targeting infectious
diseases, Viatris facilitates products’ availability through registration and supranational mechanisms. It ensures a secure supply of quality-assured products, leveraging its regional presence to address shortages and implementing strategies totackle substandard and falsified medicines. Additionally, Viatris engages in adaptive
R&D, reporting five examples of projects targeting HIV, tuberculosis and meningitis.
These adaptations aim to extend products’ shelf-lives and ease administration.

Main therapeutic areas
Cardiovascular; central nervous
system; dermatology; diabetes; gastrointestinal; immunology; infectious
disease; oncology; ophthalmology;
respiratory; women’s healthcare.
Business segments
Developed Markets; Emerging
Markets; Greater China; Japan,
Australia and New Zealand (JANZ).
Product categories*
Branded off-patent medicines; consumer health; generic medicines;
innovative medicines.
Sales presence**
Viatris reports sales in 85 countries
in scope.

O PPO RTU N ITI ES FO R VIATRIS
Expand access strategies to morehaemorrhage, in 24 countries in scope:

the company can ensure that its accessproducts and countries.

eight upper-middle income, 12 low-plans have a broad geographic reach.

Viatris implements strategies for someer-middle income, and four low-income

medicines in its portfolio, such as bev-

countries. Viatris can file for regis-

Expand engagement in voluntaryacizumab, a monoclonal antibody used

tration in other LMICs, particularly

licensing agreements

to treat certain types of cancer. In India,

those where it has previously filed

As a sublicensee in various licens-

the company considers local barriers toother products for registration, suching agreements, Viatris is following

access and some payers’ ability to pay,

as Nigeria and Tanzania. These arethrough on its commitments to reg-

to improve affordability in the private

both among the ten countries with theister in-licensed products in LMICs insector. Viatris’s strategy for this producthighest burden of disease globally forscope. Viatris can build on these efforts

includes initiatives such as a patientmaternal haemorrhage.

by continuing to register products

assistance programme, which is used tosuch as dolutegravir (paediatric) in

expand access to low-income patients

Strengthen the quality andadditional countries within the licence’s

facing affordability barriers. Viatris cangeographic scope of R&D accessscope, especially to reach children andnow scale up its efforts by establishingplans.

young women living with HIV. Having

comprehensive access strategies for

Viatris has access plans in place for all

recently signed a non-exclusive licence

more products in its portfolio, acrossof its late-stage adaptive R&D projects

for cabotegravir long-acting, used fortherapeutic areas. The company canassessed. These plans focus primarily

HIV pre-exposure prophylaxis (PrEP),

utilise such strategies in more LMICs,

on registering in countries in scope,Viatris can ensure broad registration in

especially low-income countries.

and/or supply and demand planning.

countries with high HIV burden, once

Viatris can consider broadening its

possible. The company can also explore

Expand registration of oxytocin inaccess plans to include further compo-

engaging in additional voluntary licens-

high-burden countries.

nents to improve accessibility, such as

ing agreements across other therapeu-

Viatris has registered oxytocin, an

equitable pricing plans. Furthermore,

tic areas, including non-communicableessential treatment for maternal

to ensure widespread access in LMICs,

diseases, when relevant.

*In November 2022, Viatris announced it completed the transaction with Biocon Biologics
Limited for the transfer of its biosimilars portfolio. Viatris is expected to provide commercialisation and certain transition services for two years.
Viatris has also announced its intention to divest
its API business by the end of 2023.

**Refers to countries in which sales are conducted through suppliers, pooled procurement
and/or the company sales offices.

49

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Viatris Inc

CO M PANY PRESE NCE & REVE N U E
Sales and manufacturing presence in countries in scope

Sales presence and at least
one manufacturing site
Sales presence
No sales presence
Countries not in scope

Revenue by business segment and region*2021

10,429

2022

9,769
0

5,000

3,145 2,213
2,616 2,201

10,00073
45

15,00020,000mn USD● Developed Markets ● Emerging Markets● Greater China ● JANZ ● OtherPO RTFO LI O & PRODUCTS ANALYSE D
Products in scope from the company’s portfolio

Products selected for assessment

Out of the 102 products in scope of this analysis,** Viatris has 88 products

Of the in-scope products that Viatris has in its portfolio, ten off-patent

within its portfolio, targeting a range of disease categories. These target

medicines were selected for analysis for the themes EA2 (product registra-

non-communicable diseases (NCDs) (48); communicable diseases (CDs)tion) and EA3 (expanding access and pricing strategies).

(32); neglected tropical diseases (3); and reproductive, maternal and newborn conditions (8) with 3 products falling into multiple categories. Viatris’s

Product

Indication

portfolio showcases a strong focus on NCDs. Additionally, the company

Abacavir/lamivudine (ABC+3TC)

HIV

Artemether/lumefantrine

Malaria

Bevacizumab

CancerLevonorgestrel

Contraceptive method

Insulin glargine

Diabetes mellitus

Oxytocin

Maternal haemorrhage

Sofosbuvir/velpatasvir

Hepatitis C

Tenofovir disoproxil fumarate

Hepatitis B

focuses on maternal and newborn conditions and certain CDs, including
bacterial infections, HIV and hepatitis C.
88 products
These target a range of disease­categories, namely NCDs (48); CDs(32); neglected tropical diseases(3); and reproductive, maternaland ­newborn conditions (8). Three­products fall into multiple categories.

HIV

Product is in Viatris's portfolio
Product is not in Viatris's portfolio*Viatris reports revenue by region in thesame regions that represent the businesssegments. Financial year (FY) 2021 covers
January - December 2021. FY 2022 covers January - December 2022.

Trastuzumab

Cancer

Dolutegravir/emtricitabine/tenofovirHIValafenamide (DTG+FTC+TAF)**The Generic & Biosimilar Medicines
Programme’s product scope includes
102 off-patent medicines, most of which
are listed on the 22nd World HealthOrganization’s Model List of Essential
Medicines. Essential medicines are thosethat satisfy the priority health care needsof a population.

50Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Viatris Inc

EXPANDING ACCESSE A1 . ACCESS -TO - M E D I CI N E STR ATEGY
Viatris consolidates its access-to-medicine strategy within its businessby the end of 2025, the company aims to provide antiretroviral therapy

model and corporate strategy, reporting that access is central to the com-

to 30 million patients, including two million children, living with HIV/AIDS

pany’s mission. The company reports implementing its access strategy

in the countries where it operates. Additionally, within the same time-

across all its operations and therapeutic areas.

frame, Viatris strives to extend healthcare professional education andTo support its access efforts, Viatris has developed the Global

NCD outreach initiatives to reach 100 million patients in LMICs. The exec-

Healthcare Gateway™, an operating platform that enables external

utive management team, including the Chief Executive Officer (CEO) andorganisations to partner with the company. Through this platform, thesePresident, oversee the company’s mission and access strategy and reportorganisations can leverage Viatris’s infrastructure and expertise to expand

progress to the board of directors, ensuring accountability at the highest

access to their healthcare products and services. In doing so, the com-level.

pany is supporting its corporate social responsibility (CSR) activities and

The company also reports that it aims to ensure sustainable access tosustainability commitments. Moreover, some of Viatris’s access commit-

its products by leveraging its resources to support sustainable markets andments are supported by measurable and time-bound objectives, with thecontinuously seeking opportunities to expand product registrations withincompany publicly disclosing its progress for these objectives. For example,

the coming years.

E A2 . PRO D U C T R EG I STR ATI O N
Viatris has demonstrated its ability to file or successfully register its prod-

efforts to bring biosimilars to market in LMICs, considering the additional

ucts in 88 LMICs in scope, as evidenced by the company’s registration

regulatory requirements and technical expertise involved in registeringfilings across its entire portfolio in these countries, including a high propor-

biosimilars.

tion of low-income countries, where significant gaps in access to essential

Viatris actively participates in mechanisms to facilitate registration,

medicines are prevalent.* This demonstrates the company’s ability to regis-such as the Collaborative Registration Procedure (CRP) for the Worldter products with national regulatory authorities (NRAs) in the majority of

Health Organization (WHO) prequalified (PQ) products and ZaZiBoNa.†

the LMICs in scope.

Mylan Laboratories Limited, a subsidiary of Viatris, has received over 60

Ten off-patent medicines from Viatris’s portfolio were selected forapproved registrations for WHO PQ.

assessment. The company has filed at least one of these products forregistration in 72 out of the 88 LMICs (82%) where it has pre-existing reg-

Example of Viatris’s engagement in regional joint assessments

ulatory filings,** showing the company’s extensive capacity to register its

Viatris participates in ZaZiBoNa, a regional joint assessment. As part ofproducts across a wide geographic area. Viatris demonstrates good prac-

this collaboration, five products have been recommended for approval,

tice by filing all of the ten products assessed in low-income countries.

including essential antiretrovirals (ARVs) such as dolutegravir/emtric-

Furthermore, for each of these products, the company provides evi-itabine/tenofovir alafenamide, darunavir/ritonavir, dolutegravir, anddence of the number of regulatory filings, ranging from 19 to 51 countries

lopinavir/ritonavir in a paediatric formulation, as well as isoniazid, which

within scope. Of its biosimilar products*** under assessment, Viatris has

is used to treat tuberculosis. If approved, these products could help

filed bevacizumab in 44 countries in scope, insulin glargine in 43 and tras-

improve access to quality-assured medicines in the region.

tuzumab in 51. This demonstrates that the company has made proactive

FIGURE 1 Registration filings of ten products across income categories
This figure shows the number of registrations for the ten off-patent products included in this assessment,
categorised by whether the filing is in a low-, lower-middle or upper-middle income country.
Abacavir/lamivudine (ABC+3TC)

7

Artemether/lumefantrine

7

Bevacizumab**

6

15

10

9 3
27

Levonorgestrel

11

14

Insulin glargine**

25

6

Oxytocin

25

4

12

Sofosbuvir/velpatasvir
7

Trastuzumab**
Dolutegravir/emtricitabine/tenofovir
alafenamide (DTG+FTC+TAF)

6

0

26
19

5

7
31

8

16

10

Oxytocin, indicated for post-partum haemorrhage, has been filed for registration in four
low-income countries.

8

10

Tenofovir/disoproxil/fumarate

10
12

20

14

6

30

40

50

60

Trastuzumab, a product indicated for thetreatment of breast cancer, is registered in a
total of 51 countries in scope.

Number of registration filings● Registration filings in low-income countries● Registration filings in lower-middle income countries● Registration filings in upper-middle income countries*Based on data analysed in the 2022
Access to Medicine Index and the 2021
Antimicrobial Resistance Benchmark.

**Refers to all the countries in scope
where the company has previously filed
for or successfully registered any of its
products. This includes products thatfall outside the scope of the Generic &Biosimilar Medicines Programme.

***Viatris is currently in the process oftransferring its biosimilars portfolio to
Biocon Biologics Limited. As part of theagreement Viatris will retain the responsibility for commercialisation and certain transition services for a period of
two years.

†ZaZiBoNa process is a work-sharing initiative amongst NRAs in Zambia,
Zimbabwe, Botswana, Namibia, South
Africa, Democratic Republic of Congo,
Tanzania, Malawi and Mozambique.

51

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Viatris Inc

EXPANDING ACCESS
E A 3. E XPAN D I N G ACCESS AN D PR I CI N G STR ATEG I ES
In the country-specific examples provided by Viatris, all products are covered

of-pocket cost at 18 public institutions. Secondly, in Kenya, the company

by an access strategy in the public and/or private market, thus demonstrat-

supplies levonorgestrel, a contraceptive, to both public and private insti-

ing the company’s commitment to expanding access to the ten products

tutions, including a social marketing organisation, via participation in

selected for assessment. Two strategies are complemented by additional

competitive bidding mechanisms. Between January 2020 and April 2023,

initiatives to improve affordability and availability, including a patient assis-

the company estimates to have reached 900,000 women in Kenya andtance programme and a partnership with a local organisation, encompassing

further plans to provide access to 1.3 million women within the next three

initiatives to strengthen local production (see example box, right). The com-

years.* Viatris’s success in securing these tenders and participating in bid-pany provides evidence of patients reached for nine of the ten products andding mechanisms indicate how it provided favourable terms, including

evidence of forecasting patient reach for six of the ten products.

competitive pricing, to the payers involved.

The company makes four of its generic medicines selected for assessment available in four of the in-country examples provided (Malawi,
Namibia, Uganda and Zambia), by participating in tenders issued by

Examples of Viatris’s access strategies across countries

supranational procurement organisations. Engaging in supranational pro-

In India, a lower-middle income country, the company supplied bevaci-

curement allows Viatris to expand access to affordable and quality-assured

zumab, a cancer product, during the period of analysis, through national

products while mitigating commercial risks. These tenders were awarded

pooled procurement in the private market. The price is set considering

based on price, lead time, supply capacity, and by having required registra-various factors, including volume and market competition. Additionally,tions, among other considerations.

Viatris implements a patient assistance programme, “Ashray”, thatprovides financial support to low-income payers and those not cov-

In Malawi, Viatris supplies abacavir/lamivudine, an ARV, in the public andprivate markets. The company engages in agreements with four procure-ered by private or public insurance. By considering payers’ ability toment organisations, including the Global Fund to Fight AIDS, Tuberculosis

pay and engaging in access strategies, the company engages in efforts

and Malaria (the Global Fund) and the US President’s Emergency Plan for

to improve the affordability of the product in India and reach patients

AIDS Relief (PEPFAR), which distribute the product within the country. In

across the income pyramid. Between January 2020 and February

Uganda, Viatris supplies artemether/lumefantrine, a malaria treatment,

2023, the company reached approximately 500 patients through thethrough the Global Fund, which distributes the product within the pub-programme.

lic and private markets. The company provides evidence of patient reach,

In Thailand, an upper-middle income country, the company supplies

reporting that more than 120,000 patients in Malawi and more than threesofosbuvir/velpatasvir, a hepatitis C treatment, via the national procure-million patients in Uganda received the products between January 2020

ment programme through the Government Pharmaceutical Organizationand March 2023.

(GPO), determining the product price based on the maximum procure-

For two products selected for assessment, Viatris provided two

ment price, price negotiations with the government and local NGOs,

in-country examples of collaborations with local stakeholders to increase

and the competitive landscape. The company also supplies this productthe affordability of the products. Firstly, for trastuzumab, a breast can-through private hospitals and clinics. Additionally, Viatris supplies active

cer treatment, the company collaborated with local authorities in thepharmaceutical ingredients (APIs) to the GPO to facilitate local produc-

Philippines, to address the unmet need for breast cancer therapies, result-tion of the product. The company estimates to have reached more thaning in the product being procured through a public tender. Products

30,000 patients since 2020, further estimating that more than 40,000

procured under this scheme are available to certain patients at no out-

patients will require the medication moving forward.

FIGURE 2 How many products are covered by an access strategy?
For each of the ten products selected for assessment, Viatris was requested to provide one example ofa country-specific access strategy covering that product. The company was asked to include examples
from a minimum of three low-income countries (LICs) and three lower-middle income countries(LMICs). Further examples could come from upper-middle income countries (UMICs). The types ofaccess strategies the company utilises for each product are outlined in this figure.
PublicPrivateEvidence

Additional

marketmarketof fore-initiatives toInternational

access/access/Evidence

casting

improve

Nonproprietary

pricing

pricingof patientpatient

affordability

reach

and availability**●●

Name (INN)Country

strategies

strategies

reach

Abacavir/Lamivudine (ABC+3TC)

Malawi (LIC)

●

●

●

Artemether/Lumefantrine

Uganda (LIC)

●

●

●

Bevacizumab

India (LMIC)●●

Dolutegravir/emtricitabine/teno-

Zambia (LIC)

fovir alafenamide (DTG+FTC+TAF)●

Insulin Glargine

Guatemala (UMIC)

Levonorgestrel

Kenya (LMIC)

Oxytocin

Burkina Faso (LIC)

Sofosbuvir/Velpatasvir

Thailand (UMIC)●

Tenofovir disoproxil fumarate

Namibia (UMIC)●

Trastuzumab

Philippines (LMIC)●

Viatris was the first manufacturer to offer biosimilar insulin
glargine at a discounted price to a distributor, improving
affordability compared to the branded originator. However,it remains uncertain how these discounts can effectively
enhance product affordability for all patients in need, acrossthe income pyramid.

●

●
●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

*In November 2022, Viatris declared its
intention to divest its stake in businesses
that no longer align with its future strategy by the end of 2023. This divestment
includes certain contraceptives, but isunclear whether it will involve the sale oflevonorgestrel.

●●**For example: donations, public-­private
partnerships, or patient assistanceprogrammes.

52

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Viatris Inc

EXPANDING ACCESSE A4 . E N GAG I N G I N LI CE N S I N G AC TIVITI ES
Five in-licensed products were selected for assessment: delamanid andapproximately 10,000 patients in 2022, while in South Africa, the esti-

pretomanid, indicated for tuberculosis (TB), daclatasvir, indicated formated reach exceeds 2,500 patients.

hepatitis C, dolutegravir (paediatric), indicated for HIV, and nirmatrelvir,

Additionally, Viatris is a sublicensee of a NEVL for paediatric dolute-

indicated for COVID-19.

gravir. This NEVL was facilitated by the Medicines Patent Pool (MPP) and

Viatris was granted a non-exclusive voluntary licensing agreement

involves ViiV Healthcare, CHAI, and Unitaid.

(NEVL) by the TB Alliance for pretomanid,* a multi-drug-resistant TB(MDR-TB) medicine, to commercialise this product in LMICs. Under thisagreement, the company has filed the product for registration in 27

Examples of Viatris’s licensing agreements

countries in scope. Since 2021, the product has been registered in six addi-

In March 2023, Viatris entered into a NEVL with Viiv Healthcare, facil-

tional LMICs, including Zambia, which has a high burden of MDR-TB.**

itated by the MPP for cabotegravir (CAB) long acting (LA) for HIV

Furthermore, pretomanid is WHO PQ, allowing the product to be sup-pre-exposure prophylaxis (PrEP) which will be manufactured in India. An

plied through the Stop TB Partnership’s Global Drug Facility. Through thisextended-release formulation of CAB, which in 2021 became the firstprovider, the company has supplied more than 36 countries with a highlong-acting injectable option approved for HIV PrEP. This extended dos-

burden of MDR-TB in the last three years. In 2022, Viatris partnered withing regimen, administered through a single injection every two months,

MedAccess and TB Alliance to lower the price of pretomanid by 34%, withoffers a convenient alternative to daily oral medication, improving treat-a volume guarantee by MedAccess allowing Viatris to set a ceiling price forment adherence and addressing administration challenges in LMICs. Thea six-month treatment course.

agreement allows generic manufacturers to develop, manufacture, andThe company was granted an exclusive licensing agreement by Otsuka

supply generic versions in 87 countries in scope, prior to patent expiry

for delamanid, also indicated for the treatment of MDR-TB. Through thisof the original drug in 2031. Through Viatris’ participation as a sublicen-

agreement, the company has filed for registration in six countries in scope,

see for dolutegravir (paediatric), the company has received a tentative

among them India and South Africa, which are two of the 30 countries withapproval from the USFDA for its generic fixed-dose combination (FDC)a high burden of MDR-TB. In India, the company estimates having reachedof abacavir, lamivudine and dolutegravir for use in children.

FIGURE 3 Registration filings of Viatris’s in-licensed products***
This figure shows the number of LMICs in scope where Viatris has filed for registration or registered its
five in-licensed products selected for assessment, compared to the total number of countries coveredby the licensing agreement.
Daclatasvir

36

Delamanid

6

Viatris is a sublicensee of a NEVL with Bristol Myers
Squibb, facilitated by the MPP, for daclatasvir, indicatedfor hepatitis C. Through this agreement Viatris has
increased the product’s availability by filing for registration in 36 countries in scope and supplying it via pooled
procurement mechanisms and public procurement.

57

22

Dolutegravir (Paediatric)

30

74

Nirmatrelvir

93

Pretomanid

27

0

20

67

40

60

80

● Countries covered by the licence where thecompany has filed for registration● Countries covered by the license where thecompany has not filed for registration

100

120

Countries

Viatris is a sublicensee of a NEVL with Pfizer, facilitatedby the MPP, for nirmatrelvir, a COVID-19 antiviral. Thisagreement was made after the COVID-19 vaccines wererolled out, and as a result, reduced the demand for thisproduct. Consequently, the company has not registered
the product in any LMIC within the scope. However,Viatris retain the right to register and supply the productshould the need arise.

E A 5. I M PROVI N G PRO D U C T AVAI L AB I LIT Y
Viatris’s manufacturing network comprises approximately 40 manufac-

increasing local capacity through technology transfers and trainings in qual-

turing sites worldwide, including 19 sites in LMICs in scope, such as China,

ity-assured production. The company also partners with local companies in

Egypt, India, South Africa and Zambia†. The company reports using its

Mozambique and Kenya for packaging and distributing ARVs, reporting that

global network, consisting of local, regional and global sites, to improvethe collaboration contributes to the development of local capacity.

product availability and respond to patient needs. Viatris positions its man-

Additionally, Viatris participates in global health partnerships. In June

ufacturing sites strategically to facilitate access across LMICs, reporting

2020, it became a member of the Cancer Access Partnership (CAP), estab-that its regional manufacturing and packaging sites enable benefits of cen-lished by the Clinton Health Access Initiative (CHAI) and the American

tralisation, resulting in increased regional supply.

Cancer Society. CAP aims to increase affordability and availability of 26 key

Viatris has implemented initiatives to strengthen local capacity incancer treatments in selected LMICs across Asia and Africa. The partner-

LMICs, such as investing in new packaging and distribution facilities. In

ship generates healthcare savings for governments and requires members

Zambia, for example, it established a facility dedicated to packaging andlike Viatris to fulfil specific volume and supply commitments to remain part

distribution of medicines manufactured in India, such as ARVs and anti-of the partnership.

malarials. Through this facility, the company reports working towards*Pretomanid (Pa) is used in combination with bedaquiline (B), linezolid (L), andsometimes moxifloxacin (M) to form BPaL
and BPaLM.

**Based on data analysed in the 2021
Antimicrobial Resistance Benchmark.

***Products may be available throughother mechanisms without having been
filed for registration by the company.

†Due to Viatris’s announced upcoming API
divestiture, the number of manufacturing
sites may decrease.

53Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Viatris Inc

SUPPLY & QUALITY
SQ1 . D E MAN D PL AN N I N G AN D DATA S HAR I N G
Viatris reports that its internal Rapid Response Advanced Planning system

to secure supply of in-demand products. This includes partnerships withplays a crucial role in forecasting and demand planning. This system ena-

governments and health authorities, such as those in India. In the event ofbles the company to plan its supply chain forecast demand in the different

supply disruptions caused by external events, the company alerts its com-markets in which it operates. With a 24-month forecast, Viatris aims tomercial and regulatory teams operating in local markets. These teams thenensure it has sufficient stock to meet any fluctuations in demand. In 2021,

communicate the issues and neccesary actions to local customers andthe company’s supply chain team collaborated with its commercial teams

health authorities. Furthermore, the company reports collaborating withto gain a better understanding of customer needs, with an aim of improv-

drug shortage task forces organised by national health authorities to pro-ing forecast accuracy, facilitating better production planning, and reducing

vide information regarding the supply chain and to develop solutions to

the risk of excess stock.

minimise shortages.

In certain cases, Viatris reports working with external stakeholders

SQ2 . D E LIVE RY PE R FO R MAN CE
Viatris has established a system to measure and track delivery perfor-

local market stocks with key products, to ensure orders from critical cus-mance, which includes the use of On Time in Full (OTIF) as a customer

tomers, such as hospitals are fulfilled. The company also reports offering

service level metric, measured according to customer agreements. Whenalternative products or pack sizes to customers, moving stock from othersupply delays occur, the company reports assessing all relevant safety

network locations, and transferring orders from ocean to air to reducestock levels and implementing manufacturing and packaging prioritisationtransportation time to market.

to balance supply across its network. Additionally, Viatris prioritises filling

SQ3. STO CKO UTS AN D S H O RTAG ES M ITI GATI O N
Viatris employs multiple strategies to ensure a continuous supply of its

ufacturing locations when formulating its sourcing strategy. To further

products and mitigate the risk of stockouts and shortages. This includes

mitigate risks and increase flexibility in meeting demand, Viatris leverages

maintaining safety stocks in-country and regionally, monitoring inventory

its regional and global network, collaborating with over 650 third parties.

levels of raw materials, and auditing stocking locations following good

For instance, the company operates 15 manufacturing sites across seven

distribution practice (GDP). To promote a reliable supply chain, Viatris lev-

different states in India, which helps mitigate the potential disruption riskserages its in-country and regional presence. It reports holding stocks inwithin the country.

local markets of nine countries in scope, including four upper middle-in-Viatris reports that approximately half of its APIs are sourced fromcome and five lower middle-income countries. The company also has

China and India, while the remaining half are procured from North America,

regional hubs in the Middle East and Latin America that supply countries in

Europe, and countries within its Emerging Markets segment. This segment

these regions.

covers over 165 countries, including LMICs in scope. The specific LMICs

Viatris mitigates supply chain risks through dual sourcing of key APIs

from which APIs are sourced are not disclosed. The company has produced

and finished products. It also conducts a third-party due diligence pro-APIs for a wide range of therapeutics, including ARVs and cardiovascular

gramme, specifically focusing on high-risk suppliers, to ensure compliancemedicines, both for its use in-house and to supply customers in over 100

and create action plans for identified risks. Moreover, the company has acountries. However, it announced in November 2022 its intention to divest

cross-departmental committee responsible for Sourcing and Quality, which

its API business by the end of 2023. Despite this decision, the company

considers the proximity of component and material suppliers to its man-intends to retain “some selective development API capabilities”.

FIGURE 4 What steps is Viatris taking to mitigate stockouts and shortages?
This table shows the approaches the company reports taking to ensure the uninterrupted supply of its
products.
Approaches to mitigate stockouts and shortages
Strategies to maintain sufficient stock for critical components, including buffer and safety stocks●

Conducting regular audits of its stock●

Disclosure of the frequency of stock auditing
Holding regional stocks and/or making efforts to decentralise stocks of critical components
Strategies to promote third-party supplier diversity, such as establishing alternative sources of APIs,
excipients and packaging materials
Implementation of sourcing strategies, such as procuring from local suppliers in LMICs●●●

Viatris holds stocks in local markets
of nine countries in scope. It alsouses regional hubs to supply additional countries in regions such as
Latin America.

Evidence of a policy or approach for scaling up the production of APIs to quickly adapt to meetsurges in demand, when applicable
Other initiatives to fulfil emergency orders and/or surges in demand●

Viatris has engaged in partnerships with local organisations to
respond to surges demand. During
the COVID-19 pandemic, it worked
with Indian authorities to ensuresufficient product stock.

54

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Viatris Inc

SUPPLY & QUALITY
SQ4 . MAN U FAC TU R I N G Q UALIT Y A SSU R E D PRO D U C TS
Viatris has approximately 40 manufacturing sites that are all subject togramme seeks to ensure compliance with cGMP and conducts internal

the same Viatris Global Quality Management System (QMS). These sites

audits on a one-year cycle for manufacturing sites, and on a two- to three-maintain the necessary licenses and good manufacturing practice (GMP)

year cycle for other facilities such as distribution centres, consideringcertificates required for the markets it supplies. The company reports thatfactors such as historical regulatory inspection performance. In response

the majority of sites have approval from a stringent regulatory author-

to audit observations, internal sites have 15 business days to respond andity (SRA). The remaining sites supply local markets only and are therefore

establish corrective and preventative actions within set timelines. Quality

approved by local authorities.

oversight is provided by a quality council at each site, reporting to senior

The company provides evidence of standardising quality across all

quality leadership, which ensures global quality oversight.

manufacturing sites to ensure product quality and safety. For example,

Viatris assesses its third-party suppliers through a screening process

it is standard protocol to implement the same QMS across all sites. All

and expects all suppliers to adhere to its Supplier Code of Conduct. All

manufacturing and operations strive to continuously meet the regulatory

suppliers undergo audits that seek to ensure ongoing compliance withrequirements and international standards for all markets where it has aregulatory requirements and to evaluate maintenance of regulatory report-

presence. Moreover, to ensure consistency and quality assurance across its

ing requirements. On 20 August 2020, one of the Mylan sites in India was

network, the company implements Global Quality IT systems.

issued a warning letter for significant deviations from cGMP for APIs.*

Viatris maintains a Global Operations Audit programme that plays a
key role in oversight and surveillance of quality across all its sites. This pro-However, Viatris addressed the deviations and received a closeout letter on
16 February, 2023, indicating the issues had been resolved.

SQ 5. SAFEG UAR D I N G Q UALIT Y & SAFE T Y O F MAR KE TE D PRO D U C TS
Viatris implements quality and product safety management systems

for track and trace capabilities and endpoint authorisation to prevent falsi-

designed to detect and manage any potential product recalls. The com-

fied or substandard products from reaching customers. In addition, Viatrispany’s internal global standard operating procedure (SOP) outlines theimplemented a Center of Excellence for Global Serialization dedicated toprotocol for the notification regulatory authorities should critical quality

improving the quality of the serialisation processes and to expand these

events arise. Outside the global SOP, each site must maintain a written

efforts to additional countries. This is demonstrated through the company’s

procedure for how to govern recalls based on each regulatory authority’sRest of World Verification and Traceability Initiative, developed to support

requirements.

countries to reduce the risk of falsified medicines in national supply chains.

The Product Security team performs annual risk assessments, investigates suspicious products, and collaborates with health authorities and law
enforcement as needed.
The company has invested in packaging and information technology todetect and prevent the distribution of falsified products. To ensure a uniform approach, the company implemented global policies on validation,
operations, packaging, serialisation, and product security which are applied
across manufacturing sites in alignment with government regulations. A
serialisation system is used to place a 2D data matrix on products, allowing

Example of voluntary recall during period of analysis
The company provides evidence of its ability to handle a product recall
in a timely and efficient manner. In September 2022, a market complaint was reported regarding commingled medications. The company
promptly informed the health authority in South Africa and submitteda recall proposal for the affected batch. Subsequently, a voluntary recall
was initiated within the same month.

FIGURE 5 Depth and breadth of quality-assurance strategies
This table shows the types of strategies Viatris implements to maintain the production of quality-­
assured products and to safeguard the quality and safety of products already in the market.
Quality-assurance strategies
Manufacturing quality-­

Strategies to standardise quality management systems and complianceassured products

monitoring tools across all manufacturing sites
Strategies to assesses third party suppliers on GMP compliance●●

Disclosure of the number of manufacturing sites with approval from astringent regulatory authority (SRA) or national regulatory authority(NRA) operating at maturity level 3 or 4 (ML3 or ML4)**
Safeguarding quality & safety

System for recalling products promptly and effectively and alerting theof marketed products

appropriate authorities in a timely and efficent manner●

A clear policy to mitigate the circulation of substandard and falsified
medicines, including to which authorities and/or organisations the●company reports encounters of substandard or falsified medicines
Evidence of concrete strategies to mitigate the risk of substandard andfalsified medicines
Efforts to disclose the source of finished products, including specifying
the primary manufacturing plant and disclosure of product components
and materials that are third-party sourced*Mylan Laboratories Limited, Unit 7, FEI
3003227156, at Plot No. 14, 99, & 100,Phase-II, IDA, Pashamylaram, Patancheru(M), Sangareddy District, India, fromFebruary 24 to 28, 2020.

As part of the external audit
process with third parties,
auditees are required torespond to observations cited
to Viatris’s Global Operations
Audit team within 30 days.

●

Majority of sites have SRA
approval and a few sites that
supply local markets areapproved solely by local authorities. The company’s Cairo,
Egypt site is approved by the
Egyptian Drug Authority which
operates at a ML3. However,Viatris does not disclose any
further details.
VTI is a multi-stakeholder partnership that supports countries
to reduce the risk of falsified
medicines in national supply
chains. The first two markets
under the VTI programme willbe Malawi and Nepal.

**As benchmarked against WHO Global
Benchmarking Tool (GBT).

55

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Viatris Inc

RESEARCH & DEVELOPMENTR D1 . ADAPTIVE R& D
Viatris has adaptive R&D projects in its pipeline to develop products that

doses per day and given through nasogastric intubation. This Phase I pro-are better suited for LMIC settings. During the period of analysis, theject aims to ease self-administration and patient adherence to this drug,

company provided five examples of adaptive R&D projects, including one

by reducing the dosing frequency and adapting the product’s formulation.

project which was submitted confidentially, and one in Phase I of clinicalFurthermore, the company is researching shelf-life extensions to products

development. The Phase I project is a partnership with Drugs for Neglected

for multiple diseases in scope.The projects aim to increase the current rec-Disease Initiative (DNDi) to develop a sustained-release formulation of flu-ommended shelf life of TLD (tenofovir disoproxil fumarate, lamivudine,

cytosine (5FC), an oral compound used to treat cryptococcal meningitis

dolutegravir), used for the treatment of HIV, and pretomanid, for tuberculo-

for paediatric patients with advanced HIV. Paediatric product develop-

sis, from 36 to 48 months. Additionally, Viatris is researching the extension

ments are important as this population group is often overlooked in clinicalof the shelf life of flucytosine, used to treat meningitis, from 24 to 36

research and suitable treatment options are sparse. Currently, standard

months. Increasing shelf-life can provide additional flexibility for health sys-formulations of this WHO-recommended drug are delivered in four divided

tems in LMICs.

R D2 . ACCESS PL AN N I N G
The company does not disclose having an overarching policy or structured

SRAs. When applicable, the company plans for WHO prequalification, toframework in place for systematically developing access plans during R&D

speed up access through international procurement. Furthermore, Viatris

for their adapted products.

states that it develops demand and supply plans based on work with organ-

However, for the examples of adaptive R&D provided, the company

isations such as pooled procurement and market shaping organisations.

showed evidence of access planning. For example, for adaptive R&D pro-

Additionally, Viatris partners with access-oriented organisations, such as

jects of communicable disease impacting LMICs, the company integrates

DNDi, that make it a prerequisite for companies to engage in access plan-

access planning into its business model. This includes planning to registerning during R&D, thus ensuring timely and equitable access in LMICs after

the eventual products and their adaptations as widely as possible throughproduct launch.

FIGURE 6 Examples of adaptive R&D projects in Viatris’s pipeline
International

DiseaseDevelopment

Description of

Evidence ofNonproprietary Name (INN)

in scope

stage

Partner(s)the adaptationan access plan

Sustained-release flucyto-

Meningitis

Phase I

Drugs for Neglected

Adaptation to simplify

N/A (too early insine (5FC) for patients with

Diseases initiative

inpatient and outpatientdevelopment)

advanced HIV disease(DNDi) and European

treatment of cryptococcal

and Developing

infections.

Countries Clinical Trials
Partnership (EDCTP)
Shelf-life extension TLD

HIV/AIDS

Not disclosed

N/A

Shelf-life extension from

Registration plans in

3 to 4 years

countries in scope; supply
and demand planning

Shelf-life extension flucytosine

Meningitis

Not disclosed

N/A

Shelf-life extension from

Registration plans in

2 to 3 years

countries in scope; supply
and demand planning

Shelf-life extension pretomanid

Tuberculosis

Not disclosed

N/A

Shelf-life extension from

Registration plans in

3 to 4 years

countries in scope; supply
and demand planning56