FDA has accepted Mylan’s Biologics License Application or MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway.
Mylan and Biocon sponsor MYL-1402O.
The BLA 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 Dec. 27, 2020.
Mylan and Biocon’s proposed biosimilar bevacizumab is expected to be the third biosimilar from the partnered portfolio for cancer patients in the U.S. It is currently available in India and other developing markets.
