The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is December 27, 2020
Biocon and Mylan announced that the US Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for 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.
Dr Christiane Hamacher, CEO, Biocon Biologics, said, “The US FDA’s acceptance of our BLA for 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. Biocon Biologics’ strong R&D and manufacturing capabilities have enabled us to offer two key biosimilars to cancer patients in the US and bevacizumab will further expand our oncology portfolio.”
Rajiv Malik, President, Mylan commented, “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. We’re encouraged by the results of our scientific programme to date and look forward to advancing the review of our application.”
The BLA is supported by a global randomised, controlled phase 3 clinical trial to evaluate the efficacy, safety and immunogenicity of proposed biosimilar bevacizumab versus Avastin.
The study included patients diagnosed with stage 4 non-squamous non-small cell lung cancer. Eligible patients were randomised to receive either the proposed biosimilar bevacizumab or Avastin along with carboplatin and paclitaxel for up to six cycles (18 weeks). After which the patients continued to receive monotherapy until week 42. Additionally, patients benefitting from the treatment continued on bevacizumab monotherapy. The primary endpoint was an overall response at week 18, using RECIST 1.1. Secondary endpoints included safety, progression-free survival and overall survival at week 18 and 42.
A total of 671 patients were randomised. At week 18, the study met the primary endpoint and the 90 per cent confidence interval for the best ORR (objective response rate) ratio was within the prespecified equivalence margin. The safety which included immunogenicity was found to be similar to Avastin.