Factors for manufacturers to consider as they enter the biosimilars space

Biosimilar products, which have been circulating in Europe for about a decade, have emerged as a new category of drug within the USA’s pharmaceutical market – a trend underscored by the Food and Drug Administration’s (FDA) approval of five new biosimilars since 2015 - writes Rich Tremonte, senior vice president of global generic pharmaceuticals at drug wholesaler AmerisourceBergen, in an expert view piece.

Experts project the global market for biosimilars will grow exponentially in the coming years and climb to $15 billion by 2020. In the USA, about $100 billion worth of biologics will lose patent exclusivity during that time frame, creating an opportunity for more product launches and fueling competition among pharmaceutical manufacturers seeking to bring biosimilars to market.

Yet, biosimilars – a hybrid category that occupies a space between innovator brands and generic products – are a new class of medications that requires unique planning and support throughout the development and commercialization process to ensure timely regulatory approval and optimal market access. Biosimilar manufacturers can learn from the 10-plus years of biosimilar post-marketing experience in the European market to make informed decisions when looking at other markets. However, as manufacturers begin to develop the next wave of biosimilars, it’s important they also consider these factors in commercialization.