RAPS: India Releases New Biosimilars Guidance

India’s Central Drugs Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India\'s regulators look to develop more specific guidance on postmarketing studies. The new document is a slight tweak of previous guidance issued in 2012, but includes several important changes that are now up for discussion through 30 April.

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