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 for oncology patients, the FDA acceptance of our application for proposed biosimilar bevacizumab is another important step forward to increase competition, drive health system savings, and expand our growing oncology portfolio to provide a broad range of offerings,” said Rajiv Malik, president of Mylan, in a press release. “We’re encouraged by the results of our scientific program to date and look forward to advancing the review of our application.”
The BLA was supported by findings from a global, randomized, controlled phase III clinical trial, evaluating the efficacy, safety, and immunogenicity of MYL-1402O versus bevacizumab. Patients included in the study were diagnosed with stage IV non-squamous NSCLC and, and 671 eligible patients were randomized to receive either the MYL-1402O or bevacizumab along with carboplatin (Paraplatin) and paclitaxel (Abraxane) for up to 6 cycles (18 weeks). Upon completion, the patients continued to receive monotherapy until week 42. Additionally, patients benefitting from the treatment continued on MYL-1402O monotherapy.
The primary endpoint for the study was overall response at week 18, using RECIST 1.1. Secondary endpoints for the trial included safety, progression free survival, and overall survival at week 18 and 42.
At week 18, the study met the primary endpoint and the 90% confidence interval for the best objective response rate ratio was within the pre-specified equivalence margin. The safety, which included immunogenicity, was found to be similar to the safety profile of bevacizumab.
“The US FDA’s acceptance of our BLA for a proposed biosimilar bevacizumab, co-developed by Biocon Biologics and Mylan, is an important milepost in our journey of enabling access to affordable cancer therapies for patients. Once approved, our proposed biosimilar bevacizumab will provide an affordable alternative to the branded biologic for the approved indications,” Christiane Hamacher, PhD, CEO of Biocon Biologics, said in a press release. “Biocon Biologics’ strong R&D and manufacturing capabilities have enabled us to offer 2 key biosimilars to cancer patients in the US and bevacizumab will further expand our oncology portfolio.”
U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon’s Proposed Biosimilar Bevacizumab for Review. Bengaluru, India, Hertfordshire, England, and Pittsburgh, Pennsylvania. Published March 9, 2020. biocon.com/biocon_press_release_20200309.asp. Accessed March 9, 2020.