The status and preparation for the next decade of biosimilars in the Middle Eastern and North African region

ABSTRACT

Introduction

Little is known about the status and the future potential of biosimilars in the Middle East and North Africa (MENA) region.

Areas covered

This perspective provides insights into the current regulatory landscape of some MENA countries, currently available biosimilars, the potential of biosimilars in the next decade, and challenges to overcome.

Expert opinion

Given the economic and demographic heterogeneity across the MENA countries, biosimilars could reduce significant economic unmet needs in these countries. In the next decade, biosimilars may witness higher approval rates and market share over their originators in the MENA countries. We argue that the regulatory bodies in the MENA countries should adopt the new policies of the FDA, the EMA, and the WHO, that aim to ease the biosimilar approval process. These policies are to adopt technology in the process of approval; engage health technology assessment bodies in price assessment; provide educational materials to increase awareness among providers, patients, and payers. Further, MENA countries should upgrade the external-reference pricing systems to more sophisticated ones that consider the heterogeneity in economics and needs.

KEYWORDS:

• Biosimilars
• Middle east
• North Africa
• Cost-efficiency
• Biologics

Article highlights

• Since the approval of the first biosimilar in 2006 in the European Union (EU), biosimilars have contributed to a reduction in economic unmet needs in the MENA countries.

• The lower-middle-income countries and upper-middle-income countries in the MENA region showed the highest access to biosimilars compared to the high-income countries in the region.

• Biosimilars are expected to gather more momentum than originators in the next decade. However, this is conditional on the adaptability of the regulatory bodies in the MENA to the initiatives that have been recently taken by the FDA and EMA, and the 2022 revised WHO guidelines for biosimilars.

• In the next decade, access to biosimilars in MENA countries is expected to be higher for those indicated for oncology, diabetes, and autoimmune diseases.

• Initiatives to increase the uptake of biosimilars include: 1) modernization of the external and internal reference pricing systems to capture the variations in economies, demographics, and clinical unmet needs across the MENA countries; 2) engagement of health technology assessment to ensure value-based assessment for biosimilars; 3) improvement in interchangeability standards; 4) awareness campaigns, incentives to prescribe biosimilars, and educational material to all stakeholders.

Declaration of interest

N Alkhatib holds equity in Pi Pharma Intelligence, LLC, which provides health technology solutions, scientific and consulting services to biopharmaceutical, diagnostics, and medical device companies on a nonexclusivity basis. By the company internal policy, owners, employees, and associates are prohibited from holding equity in client and sponsor organizations or contracting independently with client and sponsor organizations, or receiving compensation independently from such organizations. I Abraham holds equity in Matrix45, LLC, which provides scientific and consulting services to biopharmaceutical, diagnostics, and medical device companies on a non-exclusivity basis; government and international agencies; and academic and health care institutions. By company policy, owners, employees, and associates are prohibited from holding equity in client and sponsor organizations (except through mutual funds or other independently administered collective investment instruments), contracting independently with client and sponsor organizations, or receiving compensation independently from such organizations. Matrix45 has been previously and is currently contracted by manufacturers of biosimilars for studies and publications related to biosimilars, in addition to independently performed work on biosimilars. Ivo Abraham is Editor-in-Chief of the Journal of Medical Economics, which is an uncompensated editorship. He is the Quantitative Methods Editor of JAMA Dermatology, which is a compensated editorship contracted to Matrix45. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

We thank Pi Pharma Intelligence for the data on the availability of biosimilars and originators in the MENA regions. The data were provided to the authors at no cost.

Additional information

Funding

This paper was not funded.