Posted by Michael Wonder on 09 Mar 2020
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar bevacizumab for review
9 March 2020 - Biocon and Mylan today announced that the U.S. FDA has accepted Mylan’s biologics license application for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway.
The application seeks approval of bevacizumab 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.
The FDA goal date set under the Biosimilar User Fee Act is 27 December 2020.
