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EC Grants Celltrion Avastin Biosimilar Marketing Authorization
The European Commission (EC) authorized Celltrion Healthcare’s bevacizumab biosimilar referencing Avastin for marketing across the European Union, making it the seventh bevacizumab biosimilar to be approved in the region.
The European Commission authorized Celltrion Healthcare’s bevacizumab biosimilar for marketing across the European Union, making it the seventh bevacizumab biosimilar to be approved in the region.
Vegzelma (CT-P16) was authorized for the treatment of metastatic breast cancer, non–small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.
“The European Commission’s approval of Vegzelma™ will increase access to treatment for patients living with certain types of cancer at an affordable price….With proven similarities in efficacy and safety compared to the reference product Avastin®, Vegzelma™ will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year,” said Kevin Byoung Seo Choi, senior vice president and head of marketing at Celltrion Healthcare.
The approval came after the European Committee for Medicinal Products (CHMP) recommended Vegzelma for authorization in June. Celltrion said that the approval was based on evidence from a phase 3 pivotal trial involving patients with metastatic or recurrent nonsquamous non–small cell lung cancer. The trial compared effects of Vegzelma with the reference product (Avastin). The results showed that as a first-line treatment, the biosimilar was “highly similar” to the originator in safety, efficacy, and pharmacokinetics.
CT-P16 is the third oncology biosimilar developed by Celltrion to be approved in the European Union. Truxima (rituximab biosimilar) and Herzuma (trastuzumab biosimilar) were approved in February 2017 and February 2018, respectively.
The biologics license application for Vegzelma is currently under review with the FDA, which is expected to make a decision on approval in the third quarter of 2022. The United States has 3 FDA-approved bevacizumab biosimilars, 2 of which are on the market.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
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Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
