Poor reputation and lack of regulatory framework hindering Indian biosimilars potential

As some of the world’s best-known biologics continue to face patent expiration, the biosimilars market faces a major haul of opportunities. However, though Indian firms have launched around 50 such products in the domestic market, a new report suggests certain regulatory framework concerns for biopharmaceuticals need to be addressed, reports The Pharma Letter’s India correspondent.

Analysts suggest as many as nine drugs in the biologics category have either gone off patent or will do so by 2025. Their total revenue was $62 billion in 2018, foretelling the major opportunity for respective biosimilars.

But the Indian market’s ambivalent reputation with its 'low quality' of biologics manufacturing and biologics innovation is set to upset the apple cart.