Mylan, Biocon: FDA Accepts BLA for Proposed Avastin Biosimilar

Mylan N.V. and Biocon Ltd. on Monday said the U.S. Food and Drug Administration accepted Mylan’s biologics license application for MYL-1402O, a proposed biosimilar to Genentech’s cancer drug Avastin, in several forms of cancer.
The companies said the agency set a target action date of Dec. 27 for the application.
U.K.-based Mylan and India’s Biocon, which are exclusive partners on a broad portfolio of biosimilar and insulin products, said MYL-1402O, if approved, would be the third biosimilar from the partnered portfolio for cancer patients in the U.S.
Biosimilar products are the generic equivalents of biologic drugs, which are created from living cells.
The companies said the application seeks approval of MYL-1402O for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line 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.
Genentech is a unit of Roche Holding AG.
https://www.marketscreener.com/MYLAN-N-V-21077045/news/Mylan-Biocon-FDA-Accepts-BLA-for-Proposed-Avastin-Biosimilar-30130372/