Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development

The World Health Organization’s 2022 revisions to biosimilar approval guidelines, which allow non-local reference products, aim to save time and costs for manufacturers, impacting Middle East and North African (MENA) regulatory frameworks. However, a recent review found that only Egypt has adopted these guidelines, with regional hesitancy to source comparators outside the US or Europe hindering market development.¹

Although many countries base their approval guidelines for biosimilars off the FDA and European Medicines Agency, countries in the MENA region rely on guidances from the World Health Organization. | Image credit: Tex vector - stock.adobe.com

“Given that additional flexibility is afforded by the 2022 revision compared to the 2009 guidelines, it is likely that adoption rates will accelerate as the need for biosimilars intensifies in the coming decade. Our future planned studies include evaluation of the evolving impact of these recommendations in the MENA,” the authors wrote.

The WHO has played a crucial role in developing regulations for biotherapeutic products, starting with the 2009 guidelines for evaluating biosimilars. These guidelines have been pivotal in increasing global access to biosimilars, especially in the MENA region, where biosimilars are essential due to high demand and limited affordability of biologics.

Despite this, many African countries still lack formal biosimilar regulations, with only a few, like Egypt and Saudi Arabia, leading in approvals. The 2022 WHO revision aimed to streamline the approval process by allowing non-local reference products, addressing practical challenges in biosimilar development. However, the impact of these revisions on MENA countries' regulatory frameworks remains to be fully realized.

The present review focused on MENA countries that are WHO members and have adopted, referenced, or are drafting biosimilar regulations based on WHO guidelines (2009 or 2022). The study used evidence from national health institutions, reviewing official regulatory documents on biosimilars from each country's regulatory agency websites, using comprehensive searches in English and local languages. The analysis characterized the current state of MENA guidance on sourcing non-local reference products, comparing terminology, licensing, dosage, and administration routes, with attention to accessibility and the need for bridging studies. The review also assessed member states' responsiveness to the WHO's 2022 revisions and the effectiveness of these recommendations.

The 2022 WHO revision introduced several key changes, including replacing "similar biotherapeutic product" with "biosimilar" and "reference biotherapeutic product" with "reference product."² It also allowed for more flexibility in licensing, dosage, and route of administration by accepting non-local comparators as reference products, provided they are widely marketed in a licensed jurisdiction. This differs from the 2009 guidelines, which required national regulatory authorities to establish country-specific criteria.

Among the 19 MENA countries, Egypt, Lebanon, Morocco, Tunisia, and the United Arab Emirates (UAE) met the criteria for having drafted or published biosimilar-specific guidance referencing WHO recommendations. Egypt, Lebanon, Morocco, and Tunisia have publicly accessible guidance, while Morocco and the UAE accept WHO as an international reference despite lacking specific biosimilar guidelines.

Biosimilar adoption in the MENA region has varied, with Egypt, Saudi Arabia, the UAE, and Algeria showing promising progress, while Morocco lags due to challenges in sourcing reference products. The 2022 WHO revision aims to simplify approvals by allowing nonlocal reference products and reducing nonclinical and bridging studies, potentially lowering costs.

Despite this, only Egypt has updated its guidelines to reflect the 2022 WHO revision. Lebanon and Tunisia still follow the 2009 guidelines, and Morocco struggles to establish frameworks due to diverse health care policies. The flexible WHO guidelines are intended to streamline approvals and increase biosimilar access, but their impact has been uneven. Countries like Saudi Arabia and UAE prefer the stricter European Medicines Agency (EMA) guidelines.

More research is needed to assess the benefits and drawbacks of the flexible WHO approach and to ensure high-quality standards in biosimilar studies. Adopting FDA, EMA, and WHO policies could harmonize regulations and improve access to effective medicines in the MENA region.

References

1. Strand MW, Watanabe JH. 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. Pharmacy (Basel). 2024;12(3):94. doi:10.3390/pharmacy12030094

2. Guidelines on evaluation of biosimilars. WHO. April 22, 2022. Accessed July 16, 2024. https://www.who.int/publications/m/item/guidelines-on-evaluation-of-biosimilars