Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Hikma Pharmaceuticals plc

Hikma Pharmaceuticals Plc
HQ: London, United Kingdom • Ticker: HIK • Stock exchange: LSE • Nr. of employees: 8,800

CO M PANY SU M MARY
Hikma has access to medicine commitments integrated within its business strategy.
To expand access to its off-patent and in-licensed products, the company leverages
its strong presence and local manufacturing capacity in the Middle East and North
Africa (MENA) region. By actively participating in government tenders, the company secures the supply of medicines to the public sector in the countries in which
it operates. As a sublicensee, the company has helped lower the price of cancer
products, showcasing its ability to utilise its local presence and distribution capabilities to improve product availability and promptly respond to shifts in demand. To
ensure a continuous supply of quality-assured products, Hikma implements multiple
strategies, including data sharing initiatives and efforts to improve the managementof its own supply chain. The company maintains robust quality assurance systems
at its own sites and manages quality risks at third-party sites. Hikma reports two
examples of adaptive R&D projects, both of which are for antibiotics targeting respiratory infections. The company has also developed formulations with enhanced
stability and storage requirements, suitable for use in low- and middle- income
countries (LMICs).

Main therapeutic areas
Antidiabetics; anti-infectives;
cardiovascular; central nervous
system; gastrointestinal; oncology;
respiratory.
Business segments
Branded; Generics; Injectables; Other.
Product categories
Active pharmaceutical ingredients(APIs); biosimilars; generic medicines.
Sales presence*
Hikma reports sales in nine countries
in scope.

O PPO RTU N ITI ES FO R H I KMA
Expand registration of essential

is crucial for preventing postpartum

continue leveraging its R&D exper-

cancer products.

haemorrhage, a leading cause of mater-tise to adapt products targeting

Hikma has registered fluorouracil, a

nal mortality in the country. In Iraq,

diseases with high burdens in LMICs,

chemotherapy treatment for various

private health insurance is uncommon,

where treatment options are inef-

cancers, in one country in scope: Egypt,

and most patients rely on paying out-of-

fective or lacking, such as paediatrica lower-middle income country. The

pocket. To expand equitable access andformulations.

company has registered gemcitabine,

adequate supply for pregnant patients

another treatment targeting multiple

paying out-of-pocket, Hikma can

Expand reach to more LMICs in Africa

cancers, in two countries in scope:

employ access strategies that include

Hikma seeks to expand the availability

Algeria, a lower-middle income coun-elements to address affordability andof its generic medicines through har-try, and Sudan, a low-income country.

local barriers to access. Hikma cannessing its manufacturing footprint andHikma can consider expanding thealso engage with public procurement

established local presence across theregistration of these cancer products

authorities to expand access to oxy-

Middle East and North Africa (MENA)

to other LMICs, particularly those withtocin in the public sector.

region. Hikma can build on this foun-a high disease burden or those where

dation to expand its operations andthe company has previously filed otherEngage further in adaptive R&D toreach more LMICs, within the MENA

products for registration, such as

develop products that address theregion and beyond, especially in more

Morocco and Tunisia.

needs of people in LMICs.

countries across Africa. The company

Hikma has demonstrated its capabil-

can leverage its expertise in both directStrengthen access strategies fority to develop adaptive R&D projects

sales, and distribution and licensing

oxytocin to ensure availability andwith favourable storage conditions forpartnerships to address unmet needs

affordability for low-income andpeople living in LMICs, by developingin more countries. This is in line withvulnerable patients

single-dose sachets of the antibiotics

Hikma’s corporate strategy, as the

Hikma implements a private sector

cefaclor and cefalexin - indicated forcompany underscored the importancepricing strategy for oxytocin in Iraq thatlower respiratory infections, amongof expanding its reach into new mar-follows local pricing policies. Oxytocin

other infections. The company cankets in its Sustainability Report 2022.

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

26

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Hikma Pharmaceuticals plc

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*
2021

1,053

2022

1,141
0

500

1,000

Revenue by region*
669
691

1,500

2021

820

2022

672
2,000

2,500

1,511

3,000
mn USD● Injectables ● Branded ● Generics ● Others

847

1,433
0

500

1,000

195

866

1,500

2,000

218
2,500

3,000
mn USD● United States ● Middle East and North Africa (MENA)● Europe, United Kingdom and Rest of the WorldPO 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,** Hikma has 44 products

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

within its portfolio. Hikma’s portfolio has a strong focus on non-communi-

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

cable diseases (NCDs), particularly cancer, with 14 products. Additionally,tion) and EA3 (expanding access and pricing strategies).

the company focuses on certain communicable diseases (CDs), including
bacterial infections, for which it has ten antibiotics in scope.
44 products
These target NCDs (29); CDs (13);neglected tropical diseases (1); andreproductive, maternal and newborn
conditions (2). One product falls into
multiple categories.

Product is in Hikma's portfolio
Product is not in Hikma's portfolio

Product

Indication

Amikacin

Bacterial infection

Bisoprolol

Hypertensive heart disease
Ischaemic heart disease

Fluorouracil

CancerGemcitabine

Cancer

Metformin

Diabetes mellitus

Metronidazole

Bacterial and parasitic infection

Oxytocin

Maternal haemorrhage

Risperidone

Schizophrenia
Bipolar affective disorder

Salbutamol

AsthmaChronic obstructive pulmonary disease(COPD)

Valsartan*Financial year (FY) 2021 covers January December 2021. FY 2022 covers January- December 2022.

**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.

Hypertensive heart disease27

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Hikma Pharmaceuticals plc

EXPANDING ACCESSE A1 . ACCESS -TO - M E D I CI N E STR ATEGY
Hikma integrates its access-to-medicine commitments within its businessoutreach. To ensure accountability for its access-to-medicine commit-

model and corporate strategy, demonstrating how access is a crucial partments and activities at the senior level, the company has established anof its business operations and long-term growth. The company states a

Access to Medicine Committee, which is chaired by two members of its

commitment towards improving access to medicine across its geographies,

executive committee, one of whom is also a member of the board. The

which is supported by its sustainability focus area of “advancing health andcompany does not disclose measurable and time-bound objectives for its

wellbeing” and its corporate social responsibility (CSR) activities. These

access commitments, nor does it outline specific goals to extend its patientcommitments and CSR activities encompass its product donations, mar-reach, other than expanding its product donations and growing sales andket adaptations to address product shortages, collaborations with global

product volumes across its markets.

health organisations and its initiatives to support education and community

E A2 . PRO D U C T R EG I STR ATI O N
Hikma has filed to register or successfully registered at least one productucts for registration in low-income countries. For example, eight of thewithin its entire portfolio in nine LMICs in scope, specifically, Algeria, Egypt,ten products are filed for registration in at least one low-income country,

Iraq, Morocco, Palestine, Sudan, Syria, Tunisia, and Yemen. This demon-with three products registered in two low-income countries (Sudan andstrates the company’s ability to register products with national regulatory

Yemen) where the company operates. This is significant, as low commer-

authorities (NRAs) in LMICs in scope.

cial potential and limited regulatory capacity in low-income countries pose

Of the products within the scope of the Generic & Biosimilar Medicines

challenges to registering products and can prevent patients from receiving

Programme, ten off-patent medicines were selected for assessment.

timely access to effective and quality-assured medicines **.

Hikma has filed at least one of these products for registration in a total

Hikma does not actively engage in mechanisms to facilitate registration,of seven out of the nine (78%) LMICs in scope where it has pre-existingsuch as the World Health Organization (WHO) Collaborative Registration

regulatory filings*. Moreover, all ten products have been filed in at least

Procedure or regional joint assessments. In countries where Hikma has

one country in scope, with some registered in up to seven countries. The

local manufacturing capabilities, including Algeria, Egypt, Morocco, Sudan

company demonstrates good practice by making efforts to file its prod-

and Tunisia, it engages with governing bodies to bring products to market.

FIGURE 1 Registration filings of ten products selected for assessment 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.
Amikacin2

Bisoprolol

1

Fluorouracil

1

Gemcitabine

1

Metformin

1

Metronidazole

2

1

Risperidone

1

Salbutamol

2

1
2

2

Oxytocin, the first-line treatment for post-partum haemorrhage, has only been registered in
two countries in scope, Iraq and Algeria.

1
3

1

0

1

1

2

Valsartan

Fluorouracil, a cancer medication, has only
been registered in Egypt, a lower-middle
income country, out of all the countries inscope.

1

2

Oxytocin

1

3

1

3

2

4

6

8

10

Number of registration filings● Registration filings in low-income countries● Registration filings in lower-middle income countries● Registration filings in upper-middle income countries

Salbutamol, an asthma and chronic obstructive pulmonary disease (COPD) medication,
is Hikma’s most widely registered product,with registrations in six countries in scope.
This includes two low-income countries,
Sudan and Yemen.

Amikacin and metronidazole, two
antibiotics, have been registered infive countries in scope, including
Algeria, Iraq, Sudan and Yemen.

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

**Based on data analysed in the 2022
Access to Medicine Index and the 2021
Antimicrobial Resistance Benchmark.

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Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Hikma Pharmaceuticals plc

EXPANDING ACCESS
E A 3. E XPAN D I N G ACCESS AN D PR I CI N G STR ATEG I ES
Hikma demonstrates its commitment to expanding access to the ten prod-

markets, with lower prices offered in public tenders. While such measuresucts selected for assessment, all of which are covered by at least one

can contribute to affordability, it remains unclear whether and how Hikma

access strategy either in the public or private market. Hikma submitted

implements efforts to ensure that those at the bottom of the income pyr-examples of access strategies for one upper-middle, three lower-middle,

amid, particular those in the private market without health insurance, canand one low-income country. Nine products are further complementedafford its medicines.

by initiatives to build capacity in LMICs, such as educational activities for

For metronidazole, oxytocin and valsartan, the company provides exam-

healthcare professionals and disease awareness programmes. The com-ples of access strategies that exclusively target the private markets in Iraq

pany provides evidence of the number of patients reached, reported as the(for metronidazole and oxytocin) and Sudan (for valsartan). In both coun-

number of units sold, for all ten products. It also reports forecasting patienttries, the price of generic medicine is regulated within the private market,

reach to help anticipate future demand.

where the company follows the local price control mechanisms. Moreover,Of the ten products, the company makes at least one available in theto outperform competitors and offer more affordable prices, the company

public sector in four out of the nine countries in scope in which it operates,

utilises competitive strategies to price some of the products.

mainly by participating in tenders. During the period of analysis, Hikma
was awarded or actively participated in tenders for seven of the ten products. These tenders were awarded based on multiple criteria, such as price,
quality, and delivery time, and can be an effective tool for governments

Examples of Hikma’s access and pricing strategies
In Sudan,* a low-income country, Hikma supplies gemcitabine, a cancer
treatment, in the public sector via government tenders. The tenderto obtain discounts. This includes medicines indicated for CDs, as well as

assessment considers price and lead time as key factors, and the

medicines for NCDs including cancer, cardiovascular diseases, asthma andproduct is fully funded by the government. Additionally, in 2022, thelower respiratory tract infections. Successful tender bids indicate that thecompany partnered with the Sadagaat Charity Organization, a non-company offered favourable terms compared to other suppliers, and thatprofit organisation supporting vulnerable populations, to conduct an

it satisfied requirements set by the public payer, including competitive

educational programme in Khartoum, Sudan. The programme seeks topricing.
The company supplies its products in the public and/or private markets,
while tailoring its approach depending on the country’s context. The com-raise awareness about early diagnosis and prevention of breast cancer,
targeting 15,000 underserved women and offering free examinations toapproximately 5,000 women.

pany supplies gemcitabine and metformin in Sudan, risperidone in Algeria

In Egypt, a lower-middle income country, the company supplies fluo-

and salbutamol in Morocco through public market tenders. Within theserouracil, a cancer treatment, and amikacin, an anti-infective, in the publiccountries, some patients are covered by the national insurance scheme,

sector via government tenders. For both products, it engages in initia-

where the public authority reimburses the products. In Egypt, the com-

tives to build healthcare capacity locally. For fluorouracil, it implementspany sells three products, namely fluorouracil, bisoprolol and amikacin, in

an annual breast cancer screening programme and, in some cases,

both the public and private markets. The company follows national regula-follow-up testing to evaluate the medication response. Additionally, fortions in Egypt, which involve pricing control measures for pharmaceuticalproducts, which impact the maximum price manufacturers can set for their
medicines sold in the private market. To reach different segments of theamikacin, the company provides educational materials and access totesting and diagnostics, if not available at hospitals, seeking to ensure
the appropriate use of antimicrobials.

population, the company sets different prices for the public and private

FIGURE 2 How many products are covered by an access strategy?
For each of the ten products selected for assessment, Hikma 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.
Evidence of

Additional ­International

Public market

Private market

Evidence

forecasting

initiatives to improve

Nonproprietary

access/pricing access/pricing

of patientpatient­affordability andavailability**

Name (INN)Country

strategies

strategies

reach  

reach

Amikacin

Egypt (LMIC)

●

●

●

●

Bisoprolol

Egypt (LMIC)

●

●

●

●

Fluorouracil

Egypt (LMIC)

●

●

●

●

Gemcitabine

Sudan (LIC)*

●

●

●

Metformin

Sudan (LIC)*

●

●

●

Metronidazole

Iraq (UMIC)

●

●

●

Oxytocin

Iraq (UMIC)

●

●

●

Risperidone

Algeria (LMIC)

●

●

●

Salbutamol

Morocco (LMIC)

●

●

●

Valsartan

Sudan (LIC)*●●*The supply of this and other products
in Sudan may be interrupted due to theongoing conflict. However, the company’sefforts during the period of analysis arecaptured in the assessment.

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

●

Hikma provided
evidence of implementing initiatives
aimed at strengthening healthcare
systems in LMICs
in scope. While
such strategies
can improve
patient outcomes
and help ensure
continuity of care,
there is currently
no evidence suggesting they can
improve affordability or availability ofthe products.

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Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Hikma Pharmaceuticals plc

EXPANDING ACCESSE A4 . E N GAG I N G I N LI CE N S I N G AC TIVITI ES
Four in-licensed products were selected for assessment: rituximab, indi-

zumab and rituximab by introducing the first biosimilar versions – thecated for leukaemia and non-Hodgkin’s lymphoma; trastuzumab, indicatedformer in Iraq and Morocco, and the latter in Algeria. For both products, thefor breast and stomach cancer; and molnupiravir and nirmatrelvir, indicatedcompany reports the number of patients reached.

for COVID-19.

Furthermore, Hikma has set objectives to increase the number of

Hikma is currently engaged in two exclusive licensing agreements forpatients receiving trastuzmab in Algeria and rituximab in Iraq and Egypt.

trastuzumab and rituximab with Celltrion Healthcare Co., Ltd., who have

While licensing agreements increase availability and potentially reduce thereceived WHO prequalification (PQ) for both products. As part of theseprice through biosimilar competition, it is unclear whether Hikma takes theagreements, Celltrion is responsible for manufacturing the product, whilepayers’ ability to pay into account across different segments of the popula-

Hikma is responsible for commercialisation across the MENA region.

tion when setting the price for these products.

The company reports that it has helped reduce the price of trastu-

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

5

Trastuzumab

6 4

5Molnupiravir

95

Nirmatrelvir

93

0

10

20

30

40

50

60

70

80

90

100

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

Hikma has entered non-exclusive voluntary licenses for
two COVID-19 antivirals – molnupiravir and nirmatrelvir – through the Medicines Patent Pool (MPP). These
agreements were made after the COVID-19 vaccines
were rolled out, which reduced the demand for theseproducts. Consequently, the company has not filed
these products for registration in any LMICs within
scope. However, the company retains the right to register and supply these products, should the need arise.

E A 5. I M PROVI N G PRO D U C T AVAI L AB I LIT Y
Hikma’s manufacturing network comprises 32 sites globally, with a total of

the MENA region to enhance manufacturing capacity, partly covering its

16 located in Algeria, Egypt, Morocco, Tunisia and Sudan. Overall, the com-

injectable sites in Algeria and Morocco; however, the proportion of thepany has 23 sites in the MENA region, which may make it easier for theinvestment going towards its sites in LMICs is not reported. In the same

company to respond to demand fluctuations, prioritise certain products inyear, in response to increased demand, the company scaled up its manu-

specific markets, and understand local market needs.

facturing capacity in Algeria by increasing production of the anti-infective

The company implements efforts to scale up and develop its manufac-

amoxicillin/clavulanic acid by adding additional filling lines.

turing presence and capacity in some of the LMICs in scope. For instance,

Furthermore, the company reports engaging in technology transfers as

in 2021, Hikma began operating its newly developed oral oncology plant,

part of its toll and contract manufacturing activities in LMICs in scope. Thisin Algeria, to supply oncology products within the country. In addition, theincludes engaging in technology transfers to local pharmaceutical manu-

company is in the process of constructing two new injectable manufactur-

facturers in Egypt and Tunisia. However, the details and activities of theseing sites in Algeria and Morocco, which will be leveraged to increase thetransfers remain unclear, as the company reports that its extensive market

supply of and access to injectable medicines within these two markets.

presence across the MENA region reduces the need for them.

In 2022, Hikma invested USD 72 million in its manufacturing sites across*Products may be available through othermechanisms without having been filed forregistration by the company.

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Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Hikma Pharmaceuticals plc

SUPPLY & QUALITY
SQ1 . D E MAN D PL AN N I N G AN D DATA S HAR I N G
Hikma reports that it has established an internal system for forecasting andExamples of Hikma’s data sharing initiatives

demand planning that allows it to effectively manage inventory and identify

In Algeria, Hikma works with the Ministry of Pharmaceutical Industry topotential supply constraints. The company undertakes sales and operations

prevent product shortages by providing monthly reports with its produc-

planning on a monthly basis, and it evaluates projections for both demandtion plans and current stocks of finished goods and APIs. Additionally, inand supply. The company implements forecasting 24 months ahead, on a

Egypt, the company collaborates with stakeholders such as the Egyptian

rolling basis, and creates five-year business plans. Hikma also collaborates

Drug Authority, the Unified Procurement Authority and health insurancewith national authorities and procurement agencies to ensure its effec-

companies to improve forecasting and demand planning. Through thesetive participation in tenders and to respond to specific product needs. For

collaborations, Hikma can promptly address shortages of oncology

example, by sharing its supply plans and capacity, Hikma contributes to

products in Egypt by scaling up its manufacturing capabilities as needed.

both preventing and fulfilling shortages, thereby ensuring an adequate supply of its products.

SQ2 . D E LIVE RY PE R FO R MAN CE
Hikma has implemented a system to monitor and track delivery perfor-

meetings are held to review products’ shipping status and agree on action

mance within its MENA markets. This includes regular tracking of metrics

plans, until the issue is resolved. The company has established a structured

such as On Time in Full (OTIF), Line-Item Fill Rate (LIFR) and Fill Rate onprocess to communicate information on supply constraints and potential

a quarterly basis. The company has dedicated teams to manage its supply

delivery delays to external stakeholders, including local buyers’, throughchains at both the regional and site level.

its in-country key account managers. They work together, as needed, toIn the event of delivery delays, Hikma’s supply chain team maintains

develop a mitigation plan.

regular communication with its internal commercial team and follow-up

SQ3. STO CKO UTS AN D S H O RTAG ES M ITI GATI O N
Hikma has implemented multiple strategies to promote a continuous sup-dosage forms, it also has capabilities to manufacture APIs. One notable

ply of its products and mitigate the risk of stockouts and shortages.

example is the company’s manufacturing plant in Jordan, which special-

The company reports maintaining a safety stock of raw materials, pack-ises in APIs for oncology medicines. This capability enables the company toaging materials and finished goods, and applies a policy of a minimum stock

vertically integrate its supply chain and to manufacture and supply cancer

level of finished goods with its wholesalers and agents. To reduce the risk of

products throughout the MENA region. The company also utilises man-stockouts, the company employs specific stocking strategies as needed. In

ufacturing sites within its network to scale up production and maintain

2020, the company conducted a reassessment of its stock levels and, as acontinuity of supply of high-demand products. For instance, it reports having

result, increased its inventory levels. In addition, the company reports setting

restructured distribution models to adapt to supply needs in countries suchinventory targets per site and undertaking audit stocks on a monthly basis.

as Sudan and Yemen. Furthermore, it has worked to secure capacity with

Hikma reports specific steps to decentralise critical component stocks in thefreight forwarders and shipping companies to ensure a reliable supply chain.

LMICs where it operates. For instance, it establishes stock levels and targets
for each manufacturing site on a quarterly basis to meet demand.
The company reports taking steps to promote supplier diversity. In
2016, it implemented an enterprise risk management programme to establish alternative sources of active pharmaceutical ingredients (APIs) and
improve supply reliability and continuity. Hikma also reports it is actively
evaluating opportunities to qualify alternative sources of raw materials andpackaging materials. As part of this effort, the company recently extended
its assessment to include excipients and glass. Additionally, the company
reports that the majority of its secondary packaging materials are sourced
locally, which enables better control over product availability.
While the company is primarily involved in the production of finished

Examples of Hikma’s strategies to mitigate shortages
In Egypt, Hikma has implemented strategies to ensure a consistent
supply of essential medicines. During the COVID-19 pandemic, the company quickly responded to market demands by significantly increasing its
production of azithromycin, an anti-infective drug. In 2022, the company
reports that it maintained an uninterrupted supply of capecitabine, acancer medication, despite a tenfold increase in demand due to national
import constraints. By leveraging its local presence, the company
implemented effective measures to ensure a steady supply and meetpatients’ needs.

FIGURE 4 What steps is Hikma 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 ofAPIs, excipients and packaging materials
Implementation of sourcing strategies, such as procuring from local suppliers in LMICs
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

By identifying at-risk API sources, Hikma
implements specific stocking strategies
to minimise the risk of shortages.

●
●
●
●

Hikma leverages its API manufacturing
capability in Jordan to manufacture andsupply cancer products in the MENA
region. It also reports having a Standard
Operating Procedure (SOP) for scaling
up and transferring technology for API
processes across Hikma’s API plants,
should a surge in demand arise.

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Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Hikma Pharmaceuticals plc

SUPPLY & QUALITY
SQ4 . MAN U FAC TU R I N G Q UALIT Y A SSU R E D PRO D U C TS
Hikma reports complying with a range of industry and government regula-including at its injectable sites in Algeria and Morocco, which are currently

tions to ensure the manufacturing of quality-assured products at its sites.

under construction. Hikma uses a variety of compliance monitoring andThis includes current good manufacturing practices (cGMPs) and current

automated quality control systems to ensure quality assurance. The com-good distribution/storage practices set by various regulatory agencies suchpany has a Quality Council, which reports to the Executive Committee,

as the FDA (US), EMA (Europe), and MENA health authorities.

which oversees and shares best practices. To ensure consistent cGMP, theOf the company’s 32 manufacturing sites, 15 are inspected by stringent

company implements global quality systems across its sites, and the Global

regulatory authorities (SRAs) including US, UK or EU regulators. Of these

Quality team conducts frequent internal audits and implements corrective

15, six are located in the MENA region, but in countries out of scope ofactions for deviations.

this analysis. The remaining sites operate under national/local equivalent

Suppliers and sub-licensors are audited and required to adhere to both

authorities. The company has not submitted any products to the WHO PQ

company and regulatory standards through Quality Agreements. Before

programme, which exempts the company from manufacturing site inspec-

onboarding new API suppliers, a quality audit is conducted as a part oftions by the WHO. No warning letters from the FDA or non-compliance

Hikma’s supplier qualification system, and scheduled audits are also con-reports from the EMA were issued at Hikma’s sites in countries in scope

ducted for key suppliers. Suppliers and third parties must comply with theduring the period of analysis.

company’s Supplier Code of Conduct, with non-compliance potentially

The company utilises its engineering expertise from its FDA-inspectedleading to termination, depending on the severity of the breach.

facilities, for example in Portugal, to standardise quality across other sites,

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
Hikma implements strategies to maintain the quality and safety of its

package, that contains a product identifier, “Global Trade Item Number®

products. The company’s Pharmacovigilance Policy includes strategies to(GTIN®)”, as per the current requirements of the markets in scope.

mitigate the circulation of substandard and falsified medicines in LMICs.

Moreover, Hikma is actively working on a project to serialise its finishedThe policy includes taking immediate action and reporting any quality con-products, ensuring product tracking in the case of recalls and mitigating

cerns and/or falsified medicines encounters to the appropriate authorities

the risks of falsified medicines.

in accordance with applicable laws and regulations. Hikma also has a recall

In addition to complying with the product labelling instructions estab-procedure in place, and in the event of recall, the company informs andlished by local regulatory authorities, the company indicates both theworks with the relevant regulatory authority to ensure appropriate actions

source of the finished product on the label and the distributor’s details, if

are taken, in a timely and efficient manner.

separate from the company. Hikma’s internal Enterprise Resource Planning

The company complies with all applicable laws and regulatory requirements pertaining to falsified medicines, including any requirements for(ERP) system traces all produced lots and provides details of the origin,
manufacturing sites, and packaging sites for each lot.

serialisation and track and trace. This includes printing a barcode on each

FIGURE 5 Depth and breadth of quality-assurance strategies
This table shows the types of strategies Hikma 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

To manage third-party risks,
the company introduced “RiskRate” in 2021, an automatedsystem that assesses 96% of
its suppliers, with high-risk
suppliers facing enhanced due
diligence measures.

●

A clear policy to mitigate the circulation of substandard and falsified
medicines, including information about which authorities and/ororganisations the company reports encounters of substandard or falsified●

medicines
Evidence of concrete strategies to mitigate the risk of substandard andfalsified medicines●

Hikma’s Pharmacovigilance
Policy (PV) captures how
the company mitigates thecirculation 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
Hikma’s “Global Trade Item Number® (GTIN®)” allows
for the prompt detection of potential encounters of
substandard and falsified medicines.

*As benchmarked against WHO Global
Benchmarking Tool (GBT)32

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Hikma Pharmaceuticals plc

RESEARCH & DEVELOPMENTR D1 . ADAPTIVE R& D
Hikma has adaptive R&D projects in its pipeline to develop products thatfor Pharmaceutical Products in Algeria in August 2022, followed by cefa-

are better suited for LMIC settings. During the period of analysis, theclor in February 2023. The product adaptation means the antibiotic

company provided two examples of adaptive R&D projects for off-patentpowder can be reconstituted at the time of administration. As a result, they

medicines in scope: cefalexin and cefaclor. Both products are antibiotics

do not require refrigeration (a requirement for the pre-existing suspensionthat can be used to treat lower respiratory tract infections, amongst otherformulation). Eliminating the need for refrigeration allows more stor-

indications. The company has adapted existing formulations of cefalexin

age flexibility – an advantage in many low-resource settings. Additionally,

and cefaclor to manufacture single-dose sachets. Cefalexin single-dosethe single dose unit can be reconstituted when needed, helping to reduce

sachets received marketing authorisation approval by the National Agency

waste.

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

both products in Algeria within the period of analysis. Whilst registration

framework in place for systematically developing access plans during R&D

is a necessary first step to ensure availability in country, there is no evi-for their adapted products.

dence that the company’s access plans for adaptive R&D projects consider

However, for both examples of adaptive R&D provided, the com-other components conducive to access, such as affordability and supply.

pany showed evidence of access planning, specifically plans to register

Additionally, to increase availability beyond Algeria, the company can plan

the products in at least one country in scope. The company registered

to register the products in more countries in the MENA region.

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

Description of

Evidence ofNonproprietary Name (INN)

Disease in scope

Development
stage

Partner(s)the adaptationan access plan

Cefaclor

Lower respiratory

MarketN/A

Dry powder

Registration plans ininfections

approvalsachets

countries in scope; productapproved in Algeria

Cefalexin

Lower respiratory

Marketinfections

approval

N/A

Dry powder

Registration plans insachets

countries in scope; productapproved in Algeria

33