Convene a Meeting of Latin American Experts to Address the Gap Between National Registries on Biologics and National Surveillance Agencies Dealing with Biosimilars

AHF planned, organized and convened a meeting of experts from Latin America to address the gaps between National Registries on Biologics and National Surveillance Agencies dealing with biosimilars. The group of experts developed official recommendations on how to integrate the data from both organizations.

Although each country varies in its propensity to increase access to biosimilars, the financial pressure to adopt biosimilars in each country is high given that biologics currently consume a substantial portion of national healthcare budgets. Consequently, the need for well-defined pathways and regulations for the review, approval and pharmacovigilance of biosimilars, as well as greater transparency into the actions of governments, is a major necessity in the Region.

Moreover, in order to successfully address the gaps between national biologics registries and national surveillance agencies, countries in Latin America must enhance their efforts to improve pharmacovigilance. This includes training more regulatory staff dedicated to the endeavor, increased public and professional awareness on the importance of reporting adverse events, and better systems to capture and analyze data. Regulatory authorities should also establish a process whereby the traceability of an adverse event to a biosimilar or its reference product can be determined.

The paper developed by this meeting was published in Clinical Rheumatology. Click here to read the article.