Mylan, Biocon: FDA Accepts BLA for Proposed Avastin Biosimilar
March 09 2020 - 8:54AM
Dow Jones News
By Colin Kellaher
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.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 09, 2020 08:39 ET (12:39 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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