Biosimilars

Biosimilars

​Biosimilars are less costly imitations of drugs known as biologics, which are used to treat a range of diseases including cancer, rheumatoid arthritis, diabetes, and anemia. But they are different from generics in that they are not exact copies. With the emergence of biosimilars as a new class of biotherapeutic agents, the use of these products in Latin America has become a focus of attention. Although most Latin American countries have adopted, in general, the WHO (World Health Organization) recommendations, there are some whose regulations differ from WHO.  Not unlike other regions, the pace at which the Latin America moves toward reaching its potential of having safe and effective biosimilars has been slow. AHF has convened several meetings of regional biosimilars experts to help guide the process: 

 

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

The Americas Health Foundation (AHF) recently 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 concerning how to integrate the data from both organizations. The article, 'Recommendations to endure safety and effectiveness of biosimilars in Latin America: a point of view', was published online in February 2015 by Clinical Rheumatology and is available through pubmed. Click here to read the article.

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.


AHF Convenes Latin American Experts On Biosimiliars To Review WHO Implementation Guidelines in Region/Develop Recommendations for Harmonized Regulations

The Americas Health Foundation (AHF) convened a panel of six Latin American experts on biosimilars in December 2013 to review the current use of these biopharmaceutical agents in Latin America. The Workgroup discussed current regulatory pathways and developed recommendations on how best to improve the process and achieve harmonization between countries in the Region. The article, 'Recommendations for the regulation of biosimilars and their implementation in Latin America', was published in the GaBI Journal Generics and Biosimilars Initiative Journal in June 2014. Click here to read the article.