The FDA accepted a biologics license application (BLA) for MYL-1402O, a proposed biosimilar to bevacizumab (Avastin), for review under the 351(k) pathway, according to Biocon Biologics and Mylan, the agent’s developer.
The BLA is seeking approval of MYL-1402O for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, as well as first-line use for patients with non-squamous non-small cell lung cancer (NSCLC), recurrent glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa, and persistent, recurrent, or metastatic cervical cancer.
A goal date under the Biosimilar User Fee Act (BsUFA) was set for December 27, 2020. The proposed biosimilar is currently available in India and other developing markets.
“As we continue toward our goal of expanding access to cancer treatments…