EXPEDITING APPROVALS OF SAFE & AFFORDABLE BIOSIMILARS

While the world is discussing and troubled over 100 per cent tariffs on medicines announced just over a month back by the US administration, there is a music played to the ear of pharma producers in Asia. This music was played by the US Food and Drug Administration (FDA) last week when it made a major announcement over approvals of biosimilars, generic versions of complex biological drugs, that treat serious and chronic diseases.

- Dr Milind Kokje

The FDA announced that it has overhauled the sanction process of biosimilars to expedite their approval. In overhauling the process, the FDA will cut unnecessary red tapism which will include reduction in the human clinical studies for the drugs when other advanced testing has already established the biosimilar work as well as the regular drug. This will be a major relief to the biosimilar producers since they will no longer have to conduct comparative efficacy studies on their prospective drugs. Instead, the FDA officials will use their experience in assessing applications through comparative analytical and clinical studies to decide if their efficacy and safety is as like its branded counterpart. These moves will enable innovators to introduce safe and affordable drugs. As per the new guidelines, the pharmacists are given authority to suggest biosimilars to the patients as a more affordable option of medicines. The FDA decision is likely to accelerate access, reduce costs and expand the market.