USFDA accepts proposed biosimilar application by Mylan, Biocon for review

USFDA accepts proposed biosimilar application by Mylan, Biocon for review

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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