What Stands in the Way of Biosimilar Use Across MENA Countries?

Knowledge gaps, regulatory concerns, and cultural biases continue to hinder the adoption of generic and biosimilar medications in the Middle East and North Africa (MENA) region, underscoring the need for targeted education and policy support to empower health care professionals and promote broader acceptance, according to a study.1

“This systematic review is a pioneering effort to identify the facilitators and barriers encountered by physicians and pharmacists while implementing generic drug and biosimilar policies within the [MENA] region. By synthesizing diverse evidence, this study offers valuable insights into the regional acceptance of pharmaceutical products,” the authors championed.

The adoption of generics and biosimilars in the MENA region remains limited despite their proven potential to reduce health care costs and improve access, largely due to inconsistent regulations, cultural resistance, and varying levels of acceptance among health care providers.2 While pharmacists are generally more supportive of generics, many physicians remain skeptical of both generics and biosimilars, citing concerns about efficacy, safety, and trust in local manufacturing.

Unlike regions such as the European Union and the US—where policy-driven strategies and strong regulatory frameworks have led to significant cost savings—MENA countries lack a harmonized approach, resulting in fragmented implementation of supportive policies and slow uptake.3 Given the region's growing health care demands and its strategic importance as an emerging pharmaceutical market, this study was conducted to systematically review the facilitators and barriers identified by health care professionals when prescribing and dispensing generics and biosimilars.

Researchers conducted a comprehensive literature search across 10 databases—including MEDLINE, EMBASE, PubMed, and Cochrane—using controlled vocabulary and keywords related to healthcare professionals’ attitudes toward generics and biosimilars. Studies published between 2012 and February 27, 2024, were included to ensure relevance to current health care dynamics. The review focused on English-language studies conducted in MENA countries (plus Turkey) and involving physicians and pharmacists.

Most included studies used quantitative cross-sectional designs, primarily relying on self-administered or web-based questionnaires. Study selection was performed in Covidence by 2 independent reviewers using a 2-level screening process, with a third reviewer resolving conflicts. Data were extracted using a pilot-tested EPOC-based form, and quality was appraised using the Mixed Methods Appraisal Tool.

A systematic review of 39 studies published between 2012 and 2023 assessed physician and pharmacist perspectives on the adoption of generic and biosimilar medicines in the MENA region. The studies were conducted in 13 countries, with Saudi Arabia (n = 9), Lebanon (n = 7), and Iraq (n = 5) contributing the most. While study quality varied, including some low-quality studies allowed for a more inclusive understanding, especially from underrepresented regions.

Among the 25 studies on generic medicines, key facilitators identified included government policies promoting generics, cost-saving potential, provider education and awareness, generic availability, and pharmacist empowerment for substitution. Barriers included limited knowledge of generics’ safety and efficacy, pharmaceutical company influence, cultural biases favoring branded drugs, regulatory shortcomings, poor communication, low patient awareness, and financial disincentives.

Fifteen studies explored biosimilar adoption, with facilitators including awareness, cost-effectiveness, improved access, regulatory support, and the professional influence of pharmacists. Barriers mirrored those of generics and included major knowledge gaps, inadequate long-term data, limited educational initiatives, regulatory ambiguity, concerns about nonmedical switching, the nocebo effect, supply chain inconsistencies, and cultural resistance.

The findings also revealed differences in perceptions between pharmacists and physicians. While both groups acknowledged the economic and clinical value of generics and biosimilars, pharmacists were more likely to support substitution practices and emphasize the need for regulatory clarity and professional empowerment. Physicians expressed greater concern over clinical efficacy, safety, and nonmedical switching, particularly for biosimilars in complex or sensitive patient populations.

“Strategic initiatives at the regulatory and payer levels, including education, can raise awareness and build trust, ultimately fostering a culture that embraces generics and biosimilars in the MENA healthcare ecosystems," the authors concluded. "Such strategies can enhance the integration of generics and biosimilars into MENA healthcare systems, ultimately improving patient access to affordable treatments.”

References

1. Alqawasmeh KA, Mason T, Morris A, et al. Facilitators and barriers to generic and biosimilar medications in the Middle East and North Africa: insights from physicians and pharmacists—a systematic review. Eur J Clin Pharmacol. 2025;81(5):647-665. doi:10.1007/s00228-025-03819-5

2. Awada S, Sayah R, Mansour M, Nabhane C, Hatem G. Assessment of community pharmacists’ knowledge of the differences between generic drugs and biosimilars: a pilot cross-sectional study. J Med Access. 2023;7:27550834231167050. doi:10.1177/27550834231167049

3. Alkhuzaee FS, Almalki HM, Attar AY, Althubiani SI, Almuallim WA, Cheema E, et al. Evaluating community pharmacists’ perspectives and practices concerning generic medicines substitution in Saudi Arabia: a cross-sectional study. Health Policy. 120(12):1412-1419. doi:10.1016/j.healthpol.2016.09.018

4. League of Arab States (LAS) and the EU. The Diplomatic Service of the European Union. August 3, 2021. Accessed May 21, 2025. https://www.eeas.europa.eu/eeas/league-arab-states-las-and-eu