Indian drugmakers gearing up for slice of global biosimilars market

20 June 2016

Access to affordable biosimilars is around the corner in India, with the government looking to release guidelines after nearly two years of consultations with the pharma industry and the Central Drugs Standard Control Organization (CDSCO), reports The Pharma Letter’s India correspondent.

The guidelines address the regulatory pathway regarding manufacturing process and quality aspects for similar biologics, as well as pre-market regulatory requirements including comparability for quality, preclinical and clinical studies and post-market regulatory requirements for similar biologics.

Sources in the know pointed out that revized guidelines would be announced early July, and would bring in much clarity and aid the launch of biosimilar drugs in India.

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