Maximizing the benefits of using biosimilars in Egypt

Abstract

Background Biosimilars constitute a pathway for sustainable financing of healthcare systems in the era of expensive biologics. However, such a pathway is not free of challenges. Since the biosimilars market is expanding in Egypt, there is an urgent need for a policy framework to optimize their use and diffusion in the market. We aim to characterize a national framework based on the experiences of other countries and consultation with local experts. Methods A narrative literature review was conducted to identify biosimilars’ policy elements worldwide. A workshop was organized with experts to discuss the narrative review findings and create consensus on recommendations. Results The narrative literature review highlighted the need for biosimilar policy actions in four areas: market authorization, pricing, reimbursement, and uptake. Eighteen experts representing the Egyptian healthcare authorities attended the workshop. The most significant conclusions from the workshop included setting the price of the biosimilar at 30–40% less than its originator’s price and establishing financing protocols, in which the more expensive biologics with significant price premiums should be excluded from the formulary. Conclusions A summarized national framework policy recommendation for biosimilars was created by local experts from the main public healthcare entities in Egypt. These recommendations coincide with the international policies adopted across different countries that aim to improve patient access while sustaining health expenditure.

Examining the Impact of the World Health Organization 2022 Guidelines on Evaluation of Biosimilars for Non-Local Comparators in Biosimilar Studies on Middle East and North Africa Member States

“…However, the regulatory frameworks in many African countries are still in the nascent stages, as many countries have yet to officially adopt any regulations for the approval of biosimilars [5,7]. This contrasts with others, such as Egypt, where over 55 biosimilars are on the market [8], as well as the Kingdom of Saudi Arabia (KSA) and Lebanon, having over 36 approvals [3] as of 2023. By 2013, Egypt (in North Africa) and Lebanon (in the Middle East) have explicitly utilized these recommendations in their official regulatory framework.…”