Understanding variations in biosimilars: Correlation with risk and regulatory implications

Abstract

A second wave of blockbuster products will go off-patent between 2012–2016 in Europe and USA, triggering a rush for the approval of biosimilars or follow-on biologics. Biosimilars are approved through an abbreviated route which relies on a limited safety and efficacy data enabling biogeneric companies to develop these products at lower cost giving a price benefit to the payer. This advantage needs to be weighed against the potential risk that any variation could have with respect to safety and efficacy, especially from long-term use. The paper attempts to rationalize the current “risk” perceptions regarding biosimilars, which have been in existence over a decade in the Indian market. The differences from the Reference product are substantial yet their safety record over a long use warrants a more “realistic” rather than “speculative” assessment, keeping cost-to-benefit as an important criteria and identify ways of mitigating potential risk that are perceived for biosimilar products.