Growth of Biosimilars: Implications for Safety and Risk Management

Contract Pharma
September, 2015
Suhasini Sharma, Sciformix Corporation

It is now widely acknowledged that the new frontier of biomedical research lies in biologics, which hold the potential to yield, over time, effective treatments for conditions or diseases hitherto considered incurable or untreatable. The fight against cancer has already received a significant boost from developments in biologics and it is expected that they will provide significant therapeutic benefit to a large number of patients with malignancies, chronic inflammatory diseases and autoimmune disorders. However, on the scale of medical development, biologics are a fairly recent innovation and the majority of them are still under patent. Moreover, their unique source materials and complex manufacturing and purification processes make them extremely expensive, thereby limiting their availability to ordinary patients, and in public healthcare systems.

Nevertheless, the global outlook for biologics is positive and it is estimated that approximately two-dozen biological products with global sales of more than $67 billion will come off patent by 2020. Advances in biotechnology and the end of patent exclusivity have resulted in burgeoning opportunities for cost-effective follow-on biologics, commonly known as ‘biosimilars’ to enter the market.

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