There is a growing uptake of biosimilars in Latin America, but this has not been accompanied by an increase in pharmacovigilance, training or regulation. To address this, an expert panel was put together to discuss the issues involved. The panel’s perspectives on the current status led to six major recommendations drawn up to enhance the safe use of biosimilars across the region [1].
The panel met over two days, with discussion moderated by Dr Richard Kahn, former Chief Scientific and Medical Officer of the American Diabetes Association.
Biological production began in Argentina, Cuba and Mexico shortly after biologicals were introduced in the 1980s. Copies of reference drugs were made because there was no patent law in the region at the time. By the time patents began to expire in Europe, Japan, USA, and other countries belonging to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, there were about 100 copies of reference products already on sale in Latin America. These were registered as ‘generics’.
Around the year 2000, Europe, USA, Japan and others began discussing how to approve ‘follow-on biologics’. The first countries in Latin America to distinguish between generics and 'follow-on biologics' were Brazil and Venezuela; other countries in the region did not make the distinction until 2010. For countries in the region that have regulations for the approval of biosimilars, World Health Organization (WHO) guidelines have been adopted, but there are still countries in the region that do not differentiate between generics and ‘follow-on biologics’.
In Mexico, until recently, the approval of an intended copy of a biological drug followed the same criteria as that for a generic – so preclinical and clinical data were not required. This means that, although more than 100 million doses of copy drugs were sold between 1993 and 2012, it has not been possible to establish the risk of using these inadequately evaluated drugs.
The expert panel, whose discussion on this topic is published in the Generics and Biosimilars Initiative Journal (GaBI Journal), propose six recommendations they say will significantly enhance the safe use of biosimilars across Latin America (summarized below) [1]:
- Enhanced training of regulatory authorities on how to evaluate biosimilars.
- Establishment of a region-wide working group to share regulatory experience and plans related to biosimilars (through the WHO Regional Office for the Americas – the Pan American Health Organization [PAHO])
- Establishment of a separate working group in each country in Latin America.
- Setting up of a dedicated portion on the PRAIS website (PAHO’s Regional Platform on Access and Innovation for Health Technologies) to promote discussion on biosimilars.
- Improved pharmacovigilance and training of regulatory staff.
- Re-evaluation of products previously approved as ‘intended copy’ biological drugs according to regulations specific to biosimilars.
The panel members hope these recommendations will be implemented widely in order to facilitate the appropriate review, approval and safe use of biosimilars across Latin America.
Editor’s comment
It should be noted that ‘follow-on biologics’ approved in Latin America might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
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Reference
1. Azevedo VF, Mysler E, Álvarez AA, Hughes J, Flores-Murrieta FJ, Ruiz de Castilla EM. Recommendations for the regulation of biosimilars and their implementation in Latin America. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(3):143-8. doi:10.5639/gabij.2014.0303.032
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