You are here: Home » Companies » News
Business Standard

USFDA accepts proposed biosimilar application by Mylan, Biocon for review

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

Press Trust of India  |  New Delhi 

drugs, medicines, USFDA
File photo

The US Food and Drug Administration (USFDA) has accepted biologics license application by and for 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 were trading at Rs 302.80 a piece on BSE ,down 2.26 per cent from the previous close.

First Published: Mon, March 09 2020. 10:56 IST
RECOMMENDED FOR YOU