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.
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.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability
April 16th 2024Magnus Bodin, senior director and head of international access and policy at Biogen, presented warning signs for unsustainable biosimilar markets as well as key factors needed to create effective policies and future-proof biosimilar markets globally.