US Food and Drug Administration (USFDA) has accepted Biologics License Application (BLA) for Mylan & Biocon’s MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway.
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 (BsUFA) is December 27, 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.
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.
