PROPOSED GUIDELINES FOR SIMILAR BIOLOGICS

Central Drugs Standard Control Organization (CDSCO) has notified draft guidelines for biosimilar developers. The guidelines lay down a regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic. The CDSCO has invited suggestions and /or comments of the stakeholders by 30th April, 2016.

We shall upload a digest of these guidelines, especially on how they vary from the existing 2012 guidelines. Stay tuned for more updates on this section.

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