Biosimilars Check In: Vegzelma Launch, BLA Acceptances, China Approval

Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

Vegzelma Launch

Celltrion Healthcare launched Vegzelma (bevacizumab-adcd), a biosimilar referencing Avastin (bevacizumab), for the treatment of several cancers, according to a Big Molecule Watch report.

The biosimilar was approved by the FDA in September 2022 for use alone or in combination with other agents in patients with metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Vegzelma is also available in Canada, Japan, and the European Union. Celltrion said that the biosimilar has been added to the Medicare reimbursement list. Vegzelma is the fourth biosimilar for Avastin to launch on the US market, following Mvasi, Zirabev, and Alymsys, the last of which launched in October 2022. Vegzelma is the first Celltiron biosimilar to launch in the United States.

2 BLA Acceptances

The FDA accepted BLAs for 2 biosimilars: a ranibizumab product and a trastuzumab candidate.

The ranibizumab biosimilar was developed by Xbrane Biopharma and if approved, will be used to treat ophthalmic conditions, including age-related macular degeneration, macular edema, and diabetic retinopathy. The biosimilar references Lucentis (ranibizumab).

Xbrane said that it expects the FDA’s review process will take about 10 months, anticipating a decision on whether the product will be approved during the first half of 2024.

The trastuzumab biosimilar (HLX02) was developed by Shanghai Henlius Biotech and if approved, will be marketed by Accord BioPharma, according to Goodwin. Trastuzumab products reference Herceptin and are used to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer and HER2-overexpressing gastric or gastroesophageal junction adenocarcinoma.

The BLA included safety and efficacy data on HLX02 compared to the originator. HLX02 was also approved by the European Commission and China’s National Medical Products Administration (NMPA) in 2020. In 2021, Shanghai Henlius Biotech granted Accord Biopharma the exclusive rights for the development and commercialization of HLX02 in the U.S. and Canada.

China Approves Denosumab Biosimilar

Mabwell announced that China’s NMPA approved Mailishu, the second denosumab to receive regulatory approval in the world. The approval comes after the NMPA approved Luye Pharma Group’s Boyobei in November 2022.

Denosumab biosimilars reference Prolia/Xgeva and are used to treat and prevent bone loss and fractures associated with osteoporosis.