AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

Viatris Inc
This table is part of a November 2023 report that looks at what actions each company in scope of the Antimicrobial
Resistance (AMR) Benchmark has taken with regards to each of the Opportunities set out in its 2021 AMR Benchmark
Report Card. The full 2021 Report Card is also included in this PDF.

2021 O PPO RTU N IT Y

2023 U PDATE

What was the Opportunity shared in the AMR Benchmark?

What progress has been made on this Opportunity?

Ensure compliance with antibacterial discharge limits

Viatris continues to report that all its own manufacturing

at suppliers’ sites by tracking and publicly disclosing

sites are compliant with discharge limits in the receiving

progress and results specific to antibacterials for allenvironment. Viatris also publicly discloses this information.

sites.

In addition, Viatris publicly reports that it has adopted theViatris can set limits and quantify discharge levels to track

AMR Industry Alliance’s Antibiotic Manufacturing Standard

compliance at all suppliers’ sites and it can publicly disclose

to manage AMR risk from antibacterial manufacturing.

the results. Viatris can also publish information on how

The company publicly reports that 15 supplier sites haveit manages environmental risk related to antibacterial

been audited against the AMR Industry Alliance guidelines

manufacturing. To provide clear evidence of its progress

through 2022.

it can publicly report compliance at all sites. Disclosure of
information, including the results of audits and antibacterial discharge levels of its own sites and suppliers’ sites,
is important. It can also publicly disclose the names andlocations of its suppliers and waste-treatment plants forincreased transparency.
Improve accessibility of pretomanid (Dovprela) and

Viatris has registered, or has filed for registration, delamaniddelamanid (Deltyba).

(Deltyba®) and pretomanid (Dovprela) in six and 27 coun-

Viatris filed delamanid (Deltyba) and pretomanid (Dovprela)tries in scope of the Benchmark respectively, in comparison

for registration in seven and 23 access countries. It canto seven and 23 countries recorded in 2021.

expand the availability of these MDR-TB treatments by filing

Collaborating with MedAccess and the TB Alliance infor registration in more access countries, in particular the2022, Viatris announced an agreement to reduce the pricecountries with a high burden of MDR-TB identified by theof pretomanid by 34%. As a result, the maximum price ofWHO, where it has commercialisation rights. Accessibility

pretomanid charged by Viatris came down to USD 240

can be improved through public/private partnerships,

per six-month treatment course. As a result of the pricepatient assistance programmes and donations.

reduction, it is projected that globally an additional 36,000
patients can be treated successfully, and 31,000 adverse
events can be averted.
Furthermore, Viatris reports that the shelf life of pretomanid has been extended from 36 months to 48 months,
allowing for longer storage periods, reducing the frequencyof resupply and allowing for optimised logistics and reduced
waste.
Pretomanid is newly included in the 2023 World HealthOrganization (WHO) Model List of Essential Medicines(EML) for treatment of multidrug-resistant or rifampicin-resistant tuberculosis.

36

AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

2021 O PPO RTU N IT Y

2023 U PDATE

What was the Opportunity shared in the AMR Benchmark?

What progress has been made on this Opportunity?

Expand registration of generic antibacterial andSince 2021, Viatris has increased the number of filed regis-

antifungal medicines.

trations for amoxicillin, amoxicillin/clavulanic acid, isoniazid,

Viatris can expand registration of its generic antibiotics andlinezolid, vancomycin and flucytosine in multiple countries

antifungals listed on the 2021 WHO EML, such as linezolid,

within scope of the AMR Benchmark. Since 2021, thesepolymyxin B, and amphotericin b, to more countries, includ-

products – all listed on the WHO EML 2023 – are on aver-ing low-income countries.

age filed in two additional countries in scope. Among these,
filed registrations for linezolid have increased the most,from two countries by 2021 to 13 countries by 2023.

Fully decouple incentives for sales agents from sales

Viatris reports that in many low- and middle-income

volumes.

countries (LMICs) it sells directly to distributors, and that in

Viatris does not promote pretomanid (Dovprela) and flucy-

these countries, it does not deploy sales agents.

tosine. Viatris can expand this practice to all antibacterial

The company did not disclose an update on sales

and antifungal medicines. Alternatively, it can fully decouple

incentives in countries where it deploys sales agents forincentives for sales agents from sales volumes of all antibac-

antibacterial and antifungal medicines.

terial and antifungal medicines.
Adapt brochures and packaging.

For its generic medicines, Viatris reports it does not adapt

In order to support the appropriate use of its antibacterial

brochures and packaging for its antibacterial and antifungal

and/or antifungal medicines by patients, Viatris can adapt

medicines.

its brochures and packaging to consider local languages,

For pretomanid, Viatris reports inserting information

literacy levels, paediatric use, environmental conditions andleaflets in the regulatorily required languages and four

patient adherence to treatment.

additional languages (English, French, Spanish, and Russian),unless one of those four is the regulatory authority
language.

37

Antimicrobial Resistance Benchmark 2021

VTR

Overall Performance
2020

2021

53% 67% ▲Access to Medicine Foundation

Viatris Inc
Generic medicine manufacturer
Stock exchange: NASDAQ • Ticker: VTRS • HQ: Canonsburg, PA, US • Employees: 45,000

VTR
PERFORMANCE
Viatris performs well overall in its evaluated Research Areas compared

Performance in the Benchmark

0%

to the other generic medicine manufacturers in scope.
Responsible Manufacturing: Performs well. Reports environmental riskmanagement strategy for own sites and suppliers; co-leads in reporting
compliance with limits at own sites.
Appropriate Access: Performs strongly. Files some of its on- and offpatent products for registration in access countries. Reports several
strategies to expand access and ensure continuous supply of its relevant

healthcare professionals, however it does not decouple sales incentives

R&D

adapt brochures or packaging for patients.

50%

100%

Points0%

0/ 0Manufacturing73%

11/ 15

Access72%

18/ 2553%

Stewardship
0%

8/ 15

50%

100%

How Viatris was evaluatedfrom sales volumes for its other products. It reports comprehensive
conflict of interest mitigation for its educational programmes. It does not

37/ 55

Performance by Research Area

products.
Stewardship: Middle-performing. It does not promote two products to

Points67%

Overall score

A R&D

1

2.1 2.2 2.3 2.4

3

●

●

●

●

1

2

3

B Manufacturing ●

●

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3

C Access

●

●

●

4

5

6

7

C Stewardship

●

●

●

●

●

●

●

●

● ● ● Scored●

Not scored

OPPORTUNITIES FOR VIATRISCHANGES SINCE 2020

Ensure compliance with antibacterial discharge limits at suppliers’ sites by tracking and pub-Viatris was formed on November 16, 2020

licly disclosing progress and results specific to antibacterials for all sites. Viatris can set limits andthrough the combination of Mylan and Upjohn, aquantify discharge levels to track compliance at all suppliers’ sites and it can publicly disclose thelegacy division of Pfizer.

results. Viatris can also publish information on how it manages environmental risk related to antibacterial manufacturing. To provide clear evidence of its progress it can publicly report compliance at all sites. Disclosure of information, including the results of audits and antibacterial discharge
levels of its own sites and suppliers’ sites, is important. It can also publicly disclose the names andlocations of its suppliers and waste-treatment plants for increased transparency.
Improve accessibility of pretomanid (Dovprela) and delamanid (Deltyba®). Viatris filed delamanid (Deltyba®) and pretomanid (Dovprela) for registration in seven and 23 access countries. It can
expand the availability of these MDR-TB treatments by filing for registration in more access countries, in particular the countries with a high burden of MDR-TB identified by the WHO, where it hascommercialization rights. Accessibility can be improved through public/private partnerships, patient
assistance programs and donations.
Expand registration of generic antibacterial and antifungal medicines. Viatris can expand registration of its generic antibiotics and antifungals listed on the 2021 WHO EML, such as linezolid, polymyxin B, and amphotericin b, to more countries, including low-income countries.
Fully decouple incentives for sales agents from sales volumes. Viatris does not promote pretomanid (Dovprela) and flucytosine. Viatris can expand this practice to all antibacterial and antifungal
medicines. Alternatively, it can fully decouple incentives for sales agents from sales volumes of all
antibacterial and antifungal medicines.
Adapt brochures and packaging. In order to support the appropriate use of its antibacterial and/or antifungal medicines by patients, Viatris can adapts its brochures and packaging to consider
local languages, literacy levels, paediatric use, environmental conditions and patient adherence totreatment.

58

Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONSVTR
Revenue by business segment

Therapeutic areas: Cardiovascular, CNS and anesthesia, Dermatology,

2019

Diabetes and metabolism, Gastroenterology, Immunology, Infectious dis-2020

ease, Oncology, Respiratory and allergy, Women’s healthcare.

M&A since 2020: Viatris was formed on November 16, 2020 through the

2,000

4,000

1,723

1,195

8,000

130

1,854

10,000Emerging Markets
Other

126

12,000mn USDVTR
Revenue by region

combination of Mylan and Upjohn, a legacy division of Pfizer.

2019

8,240

2020

8,511
0

1,723
1,854

5,000

Developed markets
Greater China

PORTFOLIO for pathogens in scope

6,000

Developed Markets
Greater China
JANZ

markets

1,193

8,511
0

Business segments: Developed Markets, Greater China, JANZ, Emerging
Product categories: Biosimilars, Generic medicines, Innovative medicines

8,240

10,000JANZ
Emerging markets

15,000Other

20,000mn USDVTR
Products on the market

Comparatively large portfolio: At least 87 products: 72 antibacterial medicines; 15 antifungal medicines

00On-patent medicines: 2 (delamanid, pretomanid)

72
20

40

60

15
80

100

120

● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

Off-patent/generic medicines: 9 of 85 were selected for analysis* (amoxicillin [A], amoxicillin/clavulanic acid [A], amphotericin b [F], flucytosine [F],isoniazid [T], linezolid [T], piperacillin/tazobactam [W], polymyxin B [R],vancomycin [W])AWaRe medicines**: 24 Access group; 34 Watch group; 1 Reserve groupAnti-TB medicines**: 5

PERFORMANCE BY RESEARCH AREAA

RESEARCH & DEVELOPMENT

As a generic medicine manufacturer, Viatris is
not evaluated in this Research Area.

B

RESPONSIBLE MANUFACTURING Evaluated: antibacterials manufacturing (APIs and drug products)

B.1

Environmental risk-management for own

also requests and reviews the discharge levels ofor external private and public waste-treatmentsites and suppliers; tracks compliance

its suppliers as part of these audits. It is unclear

plants; (2) a list of these suppliers and plants; orwith limits at own sites

how many of the 35 suppliers are assessed so(3) the levels of antibacterial discharge from its

far and have quantified discharge levels.

own or suppliers’ sites.

Viatris reports a strategy to minimise the environmental impact of wastewaters and solid

There is limited information on the require-

waste from antibacterial manufacturing at its

ments Viatris makes of external private andsites, including audits every five years. It reports

public waste-treatment plants, in terms of strat-

setting discharge limits in the receiving environ-egy, audits and antibacterial discharge limits andment for all antibacterials manufactured at its

levels.

B.3

System in place to maintain production
quality for own and suppliers’ sites; norequests for official corrective action

Viatris reports that its own sites and suppliers

sites, based on PNECs to limit AMR, as recom-

have a system to maintain high-quality antibacPublicly discloses some information on

terial production consistent with international

levels are quantified at all sites using a mass

environmental risk management and

GMP standards. This includes periodic risk-balance approach. All its sites, or 100%, arequantifying discharge levels at own sites

based audits and tracking of corrective and pre-mended by the AMR Industry Alliance. Discharge

B.2

reported to be compliant with discharge limits.

Viatris publishes some components of its envi-

ventive actions. Viatris also requires its suppli-

It reports that eight of its sites that manufac-

ronmental risk-management strategy. It is a

ers to audit their own suppliers. The Benchmark

ture antibacterials are ZLD and that recycled

member of the AMR Industry Alliance, whichfound no requests for official corrective action

water was analysed for presence of antibacteri-

publishes a list of recommended antibacterial

from the FDA or EMA related to non-conformi-

als which was found to be zero.

discharge targets. Viatris publishes its commit-

ties with cGMP at Viatris’ own sites or any sub-ment to setting these targets. It also publicly dis-sidiaries that manufacture antibacterials.

Viatris requires third-party suppliers of antibacterials to follow the same standards, includ-

closes that all of its own sites have quantified

ing limits based on PNECs. It engaged with

antibacterial discharge levels. It does not publish:

EcoVadis to start an audit programme among its(1) the results of environmental audits, whether

top 35 antibiotic suppliers to assess AMR risk. It

conducted at its own sites, the sites of suppliers* See Appendix VII for information about
eligibility criteria for products.
** Listed on the 2019 WHO EML.

59

Antimicrobial Resistance Benchmark 2021

C

Access to Medicine Foundation

APPROPRIATE ACCESS & STEWARDSHIP – ACCESS

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries***
Viatris is not eligible for indicators: C.1.3 andto its on-patent medicines in access coun-ings and supply reviews. Viatris mitigates against

C.2.3. For more information, see Appendix VII.

tries through public/private partnerships, dona-

shortage risks by keeping buffer stocks and con-tions, tenders and a named patient access pro-ducting supplier audits. It registers several of

Filed to register on-patent medicines ingram. Viatris partners with the GDF–Stop TB

its products at multiple production sites, includ-15 access countries on averagePartnership to provide pretomanid at a global

ing in China, South Africa, and Zambia, ensuring

Viatris performs above average, filing its two rel-access price of USD 364 per treatment course

geographical diversification and dual sourcing.

evant on-patent medicines for registration in

to 150 countries. Viatris provides evidence ofViatris estimates 50% of its main products’ APIs

access countries. Its most widely filed relevant

patient reach and geographic reach for all its

or finished forms to be dually sourced. To miti-

product is the anti-tuberculosis medicine preto-

reported approaches. In 2019 and 2020, it pro-gate against sub-standard and falsified products,

manid, filed in 23 access countries, including fivevided 6,000 treatment courses of delamanid

Viatris has a dedicated infrastructure to moni-

LICs. Under its licensing agreement with Otsuka,

through a government tender in South Africa.

tor product safety and manage related efforts.

C.1.1

Viatris filed delamanid for registration in sevenaccess countries.
C.1.2 Filed to register off-patent/generic med-

This includes, but is not restricted to, a prodC.2.2 Some strategies to expand access to

uct portfolio risk assessment process, analysis

off-patent/generic medicinesand market monitoring, a suspicious order mon-Viatris has an average performance. It reports

itoring program, and a product diversion pro-that it aims to expand access to its off-patent/

gram that includes anonymous reporting mech-

Viatris has an average performance, filing seven

generic medicines in access countries throughanisms and a supplier code of conduct. Viatrisof its nine sample off-patent/generic medicines

equitable pricing and public/private partner-

uses security features such as serialisation or 2D

for registration in seven access countries on

ships. For example, Viatris partnered withdata matrix.

average. Its most widely filed relevant productstakeholders such as UNITAID, CHAI, and theis vancomycin, filed in 15 access countries. Six

Global Fund to provide flucytosine, prior toof its sample products are filed in less than 10

WHO-prequalification.

icines in 7 access countries on average

access countries. Five of its sample products are
filed for registration in at least one LIC.

C.3

Several strategies to ensure continuous

C.2.1 Several strategies to expand access to

Viatris performs above average, with strate-

supplyon-patent medicines

gies reported in all four areas assessed. Viatris

Viatris performs above average, with accessensures accurate demand planning and data

strategies reported for both its two relevant

sharing by having a 24-months horizon planningon-patent medicines. It aims to expand accessand daily, weekly, or monthly operational meet-C

APPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally
C.4

Comprehensive COI mitigation strategies

inappropriate use of such medicines.

share results in a peer-reviewed medical jour-in place for its educational programmes

Viatris does not report to engage in market-

Viatris performs strongly in conflict of interesting practices that aim to address the appropriate

Pretomanid Resistance Surveillance Program,(COI) mitigation for the five AMR-related edu-

use of its antibacterial and/or antifungal med-

which is focused on resistance against pretoma-

cational programmes for HCPs assessed by theicines as its marketing materials do not reflect

nid in eight countries until 2025. Once data col-Benchmark. To mitigate COI for one programme,

emerging resistance trends or include treatment

lection has been completed, Viatris intends toit provides financial resources to an independ-

guidelines for healthcare professionals to raise

share data with regulatory authorities and in aent third party (Omnicuris), which collaborated

awareness of AMR and address appropriate use.

peer-reviewed journal article.

nal. Moreover, Viatris runs the multinationalwith another independent organisation (ISCCM)
to develop the programme. The remaining four

C.6

Does not report adapting brochures and/or packaging to facilitate appropriate

programmes have all three COI mitigation strat-

use by patientsegies looked for by the Benchmark: (1) content
is developed independently from its marketing

Viatris does not report adapting brochures and/department; (2) a pledge not to provide financial

or packaging to facilitate the appropriate use ofor material incentives; and (3) it does not use

its antibacterial and/or antifungal medicines bybranded materials.

patients.

C.5

Engages in sales practices but does not

C.7

engage in marketing practices to address

As a generic medicine manufacturer, Viatris

appropriate use

is not assessed in this indicator but its activ-

AMR Surveillance

Viatris performs above average in sales prac-

ities in AMR surveillance are reported. The

tices. It does not deploy any sales agents to pro-Benchmark notes that Viatris is active in two

mote pretomanid and flucytosine to healthcare

AMR surveillance programmes. It supports theprofessionals. However, for the remaining anti-

national Data Development programme, which

bacterial and/or antifungal medicines it does not

is a retrospective study of antimicrobial resist-

report whether it decouples incentives for sales

ance in ICU patients in India and has been run-agents from sales volumes to help prevent thening since 2019. Viatris reports that it intends to*** 102 low- and middle-income countries where better access to medicine ismost needed.

60