FDA Approves Biocon’s Avastin Biosimilar

The FDA has approved the fifth biosimilar of Genentech’s Avastin (bevacizumab). Biocon Biologics' biosimilar Jobevne (bevacizumab-nwgd), like Avastin and other approved biosimilars, is a recombinant humanized monoclonal antibody used to treat several different types of cancer.

Bevacizumab is a vascular endothelial growth factor (VEGF) inhibitor, which blocks blood vessel growth. It is used to treat cancers such as colorectal, lung, glioblastoma, kidney, cervical, and ovarian cancer. Other biosimilars include Mvasi, Zirabev, Alymsys, Vegzelma and Avzivi.

The approval for Jobevne was based on comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data. The data demonstrated that there were no clinically meaningful differences between Jobevne and Avastin in terms of pharmacokinetics, safety, efficacy, and immunogenicity.

Related: Avastin Biosimilars Catching On For Patients With Lung and Colorectal Cancer

The Avastin biosimilars are increasingly being used to treat lung and colorectal cancer, being used by 1 in 5 patients with these cancers, according to a study that was released at the Academy of Managed Care Pharmacy (AMCP) held in Houston last week. This research was conducted based on data from Carelon Research’s Healthcare Integrated Research Data from July 1, 2017, through March 31, 2024. Carelon is a research arm of Elevance Health, formerly known as Anthem.

Across bevacizumab’s cancer indications, the biosimilars have a market share of 89%, according to Samsung Bioepis Biosimilar Market Dynamics report for the first quarter of 2025.

There are an estimated 40 drugs in the bevacizumab biosimilars landscape in the marketed and pipeline stages, according to a 2024 report from market research company DelveInsight.

Bevacizumab is also used off-label to treat patients with wet age-related macular degeneration (wet AMD). For this use, bevacizumab is obtained from compounding pharmacies, which repackage small quantities into syringes for intravitreal injection.

Related: FDA Announces Goal Date for Resubmitted Bevacizumab to Treat Wet AMD

The FDA is currently reviewing an application for an ophthalmic formulation of bevacizumab for wet AMD. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of Aug. 27, 2025, for Outlook Therapeutics’ biologics license application (BLA) for ONS-5010 (bevacizumab-vikg). If approved, the therapy would be branded as Lytenava and is expected to receive 12 years of regulatory exclusivity.