Facilitators and barriers to generic and biosimilar medications in the Middle East and North Africa: insights from physicians and pharmacists-a systematic review.

Background: The adoption of generic and biosimilar medications is crucial for improving healthcare accessibility and cost savings in the Middle East and North Africa (MENA) region. Understanding the factors that influence their acceptance is crucial for developing effective strategies for promoting their use.

Purpose: This systematic review aimed to examine the facilitators and barriers identified by healthcare professionals while prescribing and dispensing generic and biosimilar medications in the MENA region, focusing on their perceptions, knowledge, and attitudes.

Methods: Following Cochrane guidelines and the "Guidance on the Conduct of Narrative Synthesis in Systematic Reviews," a comprehensive search of electronic databases and grey literature was conducted from 2012 to 2024. Studies assessing physicians' and pharmacists' perspectives on generics and biosimilars in the MENA region were included. Quality appraisal was performed using a standardized tool, the mixed methods appraisal tool (MMAT). The findings were synthesized using a descriptive analysis.

Results: Of the 3570 screened citations, 39 met the inclusion criteria. Among them, 25 studies addressed facilitators and barriers to adopting generic medications, whereas 15 focused on biosimilars. Facilitators of generic medications included understanding the use of generics as cost-effective substitutes, supportive government policies, generic medication awareness, and pharmacists' empowerment to substitute medications. Barriers included knowledge gaps leading to distrust in efficacy and safety, the influence of pharmaceutical companies, cultural biases favoring brand name drugs, regulatory challenges, low consumer awareness, and concerns about pharmacists' profitability. Facilitators for biosimilars were mostly similar to generics, with an added emphasis on access benefit recognition when using biosimilars. Unique barriers included concerns about the lack of long-term safety data, hesitancy toward non-medical switching, and nocebo effect concerns. The quality assessment indicated that most studies were of moderate quality, with limitations such as sample size and representativeness, validity of the measurement tools, and potential biases of the researchers.

Conclusion: Significant knowledge gaps regarding regulatory approval, safety, and efficacy hinder the adoption of generic drugs and biosimilars in MENA. Targeted educational initiatives at the regulatory and payer levels are essential for bridging these gaps, enhancing awareness, and fostering acceptance. Implementing comprehensive educational programs for physicians and pharmacists is crucial to support the transition toward the greater use of generics and biosimilars.