The FDA deferred action on the Biologics License Application for the potential biosimilar of bevacizumab, MYL-1402O, due to travel restrictions related to COVID-19 that prohibited the agency from completing an inspection of the manufacturing facility, as required by the standard review process.
The FDA has deferred action on the Biologics License Application (BLA) for the potential biosimilar of bevacizumab (Avastin), MYL-1402O, due to travel restrictions related to coronavirus disease 2019 (COVID-19) that prohibited the agency from completing an inspection of the manufacturing facility, as required by the standard review process, Biocon Biologics Limited announced in a press release.1
The BLA for the proposed biosimilar was accepted by the FDA in March 2020, with an action date goal of December 27, 2020. The company currently awaits dates for the inspection. No additional observations were made related to the BLA.
MYL-1402O is under consideration for the treatment of patients with previously untreated metastatic colorectal cancer (CRC) and metastatic CRC in the second-line setting in combination with fluorouracil-based chemotherapy, as well as for the treatment of previously untreated nonsquamous non–small cell lung cancer (NSCLC), recurrent glioblastoma, and metastatic renal cell carcinoma when used in combination with interferon-alpha. It is also being considered as treatment of patients with persistent, recurrent, or metastatic cervical cancer.2
The agent was evaluated in a global, randomized, controlled phase 2 study in comparison with bevacizumab as treatment of patients with stage IV nonsquamous NSCLC. Approximately 671 patients were randomized to receive either MYL-1402O or bevacizumab in combination with carboplatin and paclitaxel for up to 18 weeks followed by bevacizumab/MYL-1402O monotherapy through week 42.
The primary end point was objective response rate at week 18 by RECIST 1.1 criteria, which was achieved within the prespecified equivalence margin for the 90% confidence interval. Secondary end points included safety, progression-free survival, and overall survival at weeks 18 and 42.
In regard to safety, MYL-1402O was found to be similar to bevacizumab.
1. Biocon Biologics Statement on the Status of Bevacizumab FDA Action Date in Dec 2020. News Release. Biocon Biologics. December 25, 2020. Accessed January 5, 2021. https://bit.ly/3hIMPRD
2. U. S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Bevacizumab for Review. News Release. Biocon Biologics. March 9, 2020. Accessed January 5, 2021. https://bit.ly/38AHuWb.