USFDA accepts proposed biosimilar application by Mylan, Biocon for review

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The US Food and Drug Administration (USFDA) has accepted biologics license application by Mylan and Biocon for a proposed biosimilar to Bevacizumab for review, according to a regulatory filing. The application seeks approval of Bevacizumab for the first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, among other related-ailments.

The two firms said that "the US Food and Drug Administration has accepted Mylan's biologics license application (BLA) for MYL-14020, a proposed biosimilar to Avastin (bevacizumab) for review under the 351(k) pathway".

The shares of Biocon were trading at Rs 302.80 a piece on BSE , down 2.26 per cent from the previous close. 

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