The FDA has accepted the Biologics License Application for MYL-14020, a biosimilar to bevacizumab.
If approved, the application would have several indications, including first and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line treatment 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 acceptance comes after a global, randomized controlled phase 3 clinical trial comparing the biosimilar bevacizumab to the branded version. The trial included a total of 671 patients who were randomized to receive either the biosimilar or the brand version along with carboplatin and paclitaxel for 18 weeks. The patients then received monotherapy until week 42.
By week 18, the study met its primary endpoint of best objective response rate with a 90% confidence interval. The safety was also found to be similar to the brand version for the biosimilar. Safety, progression-free survival, and overall survival at weeks 18 and 42 were secondary endpoints for the trial.
If the application is ultimately approved by the FDA, Dr. Christiane Hamacher, CEO of Biocon Biologics, said the biosimilar will “provide an affordable alternative to the branded biologic for the approved indications.”
The biosimilar bevacizumab is currently available in India and other developing markets. The FDA set a goal date of Dec. 27, 2020.