Biosimilars set to take center-stage as exclusive biologic bubble bursts

The exponential rise of biosimilars in clinicals trials and applications for US Food and Drug Administration (FDA) approval continues to rise. According to figures from the Biosimilars Council, brand biologic medicines worth an estimated $81 billion in global annual sales will lose their patents by 2020. This provides a significant opportunity for the development of lower cost biosimilar alternatives, with the market expected to expand more than twenty-fold in the next five years. Dr Michelle Maxwell reports.

Biological products are generally derived from a living organism. They come from many sources, including humans, animals, microorganisms or yeast. Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. The Center for Biologics Evaluation and Research (CBER) is responsible for ensuring the safety and efficacy of the biological products.

New biological products, like chemical drugs, are required to go through regulatory approval which involves submission of a full complement of product-specific data, including animal and clinical study data. But the tables turned in the US in 2010, when the President signed legislation creating an abbreviated approval pathway for biosimilar products to promote development and create competition, with the goal of increasing treatment options and reducing healthcare costs. This led to numerous big pharma and biotech companies beginning the production of biosimilars.