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Tweaks In Indian Biosimilar Guidelines Target ‘Residual Risk’

 
• By Anju Ghangurde

India's latest set of guidelines for biosimilars seeking market authorization in the country has specified additional post marketing study requirements to "further" reduce the "residual risk" of similar biologics.

India has issued new guidelines for biosimilars, which largely build on the 2012 guidance in the area, and note that additional safety data "may need to be collected" after market approval through a pre-defined single arm study of "generally more than 200 evaluable patients" and compared to historical data of the reference product.

"The study should be completed preferably within two years of the marketing permission/manufacturing license unless otherwise justified," it says.

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