Trastuzumab “can” be sold as a bio similar to Roche’s Trastuzumab

The division bench of the Delhi High Court, of Badar Durrez Ahmed and Sanjiv Sachdeva, has permitted Biocon and Mylan to use Roche’s product data for Trastuzumab. Roche had challenged the approval mechanism adopted by the central drug standards controller (CDSCO) in giving Biocon and Mylan approval for its biosimilar drug and their product inserts containing product data before the single judge.

 Earlier, the Delhi High Court, in a single bench order, had allowed Biocon and Mylan to market their product without any reference to Roche’s product or biosimilarity.

 Stay tuned for a fuller report!

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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.