USFDA Accepts Biocon’s Cancer Drug Application For Review

The US drug regulator has accepted Biologics License Application (BLA) for Mylan and Biocon’s proposed biosimilar Bevacizumab for review.

Biocon and Mylan N.V. announced on Monday (9 March) that the US Food and Drug Administration (USFDA) 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 biologics license application (BLA) seeks approval of bevacizumab for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; firstline use for patients with non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma in combination with interferon alfa; and persistent, recurrent or metastatic cervical cancer.

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 27 December 2020.

Biocon and Mylan’s proposed biosimilar bevacizumab is expected to be the third biosimilar from the partnered portfolio for the cancer patients in the US. It is currently available in India and other developing markets.

Dr Christiane Hamacher, CEO, Biocon Biologics, said: “The US FDA’s acceptance of our BLA for a proposed biosimilar bevacizumab co-developed by Biocon Biologics and Mylan is an important milepost in our journey of enabling access to affordable cancer therapies for patients. Once approved, our proposed biosimilar bevacizumab will provide an affordable alternative to the branded biologic for the approved indications. Biocon Biologics’ strong R&D and manufacturing capabilities have enabled us to offer two key biosimilars to cancer patients in the U.S. and bevacizumab will further expand our oncology portfolio.”

Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar bevacizumab is one of the 11 biologic products being co-developed by Mylan and Biocon for the global marketplace.

Biocon is an innovation-led global biopharmaceuticals company.

Shares of Biocon were currently down 1.66% at Rs 304.65. The stock has traded in the range of Rs 302 and Rs 308.05 so far during the day.-Business Standard