The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.
The FDA has accepted a Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to bevacizumab (Avastin), according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.
“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, MD, CEO of Biocon Biologics, said in a statement.
MYL-1402O is being considered as a treatment for patients with previously untreated metastatic colorectal cancer (CRC) and metastatic CRC in the second-line setting when used in combination with fluorouracil-based chemotherapy; previously untreated nonsquamous nonsmall cell lung cancer (NSCLC); recurrent glioblastoma’ metastatic renal cell carcinoma when used in combination with interferon-alpha; and persistent, recurrent, or metastatic cervical cancer.
The biosimilar was studied in a global, randomized, controlled phase III trial in comparison with bevacizumab in patients with stage IV nonsquamous NSCLC. A total of 671 patients were randomized to receive either the biosimilar or reference bevacizumab in combination with carboplatin and paclitaxel for up to 18 weeks of treatment, followed by bevacizumab/MYL-1402O monotherapy through week 42.
The primary end point of the study was overall response rate (ORR) at week 18 by RECIST 1.1 criteria and second end points included safety, progression-free survival (PFS), and overall survival (OS) at week 18 and at week 42.
The primary objective was achieved with an ORR at week 18 within the prespecified equivalence margin for the 90% confidence interval, according to the press release. Safety of MYL-1402O was also found to be similar to the reference product.
A phase I pharmacokinetic comparability study presented at the 2017 ASCO Annual Meeting demonstrated the biosimilarity of MYL-1402O to both the US and EU bevacizumab reference products in healthy male volunteers.2A total of 110 evaluable patients were randomized between the 3 arms. In each arm, the subjects were given bevacizumab or the proposed biosimilar at 1 mg/kg intravenously over 90 minutes.
Bioequivalence was achieved between the 3 arms with 90% confidence intervals all between 0.80 and 1.25 for each comparison. Secondary pharmacokinetic parameters of AUC0-tand Cmaxwere comparable in terms of 90% confidence intervals for ratios within 80% to 125%.
Treatment-emergent adverse events (TEAEs) were experienced by 89% of the patients who received the biosimilar, 78% who received the US reference product, and by 76% of patients who received the EU reference product, with no unexpected adverse events reported that differed from the known safety profile of bevacizumab. All of the TEAEs were either grade 1 or 2 in severity.
“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 program to date and look forward to advancing the review of our application,” Rajiv Malik, president of Mylan, said in the press release.
MYL-1402O is already approved for use in India and other developing markets.