European Commission Approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer
14.9.2022 16:04:00 EEST | Business Wire | Press release
Celltrion Healthcare announced today that the European Commission (EC) has approved Vegzelma™ (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin®, 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,” said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. “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.”
The EC approval of Vegzelma™ follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2022.
Today’s approval is based on the totality of evidence, including the phase III pivotal trial in patients with metastatic or recurrent non-squamous non-small cell lung cancer. Results showed that, as a first-line treatment, Vegzelma™ is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.2
Vegzelma™ (CT-P16) is Celltrion’s third oncology biosimilar approved for use in the EU, following the approval of Truxima® (biosimilar rituximab) and Herzuma® (biosimilar trastuzumab). Vegzelma™ was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA) in September 2021. Approval is expected during the third quarter of 2022.
- ENDS -
Notes to Editors:
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com
About Vegzelma™ (CT-P16, biosimilar bevacizumab)
Vegzelma™ is an anti-cancer monoclonal antibody treatment biosimilar to Avastin® (bevacizumab). Vegzelma™ is a recombinant humanised monoclonal antibody which binds to VEGF, the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (KDR) (VEGFR-2), on the surface of endothelial cells. Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.3 In the EU, Vegzelma™ is indicated for the treatment of patients with metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell carcinoma, ovarian cancer, advanced cervical cancer and metastatic breast cancer.
References
1 Avastin is a registered trademark of Genentech Inc.
2 Ohe Y et al., Randomized Phase III Study Comparing the Efficacy and Safety of CT-P16, a New Biosimilar, to Reference Bevacizumab (Avastin) In Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC). Proceedings: American Association for Cancer Research (AACR) Annual Meeting 2022; April 8-13, 2022 New Orleans, Louisiana.
3 European Medicines Agency Summary of Product Characteristics (SmPC), Avastin. Available at https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf [Last accessed August 2022].
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220817005324/en/
Contact information
Holly Barber
hbarber@hanovercomms.com
+44 (0) 07759 301620
Donna Curran
dcurran@hanovercomms.com
+44 (0) 7984 550312
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Echodyne to Open Major New Manufacturing Facility to Meet Rapidly Growing Global Demand11.2.2026 14:00:00 EET | Press release
Echodyne, the radar platform company, today announces a major near-term expansion in its advanced radar production capacity. Echodyne’s new 86,350-square-foot facility will provide enough manufacturing and warehouse space to produce and ship more than 30,000 radars per year. The company’s modular manufacturing approach allows production capacity to flex to match varying demand across product lines as well as seamlessly introducing new product lines and capabilities. The investment reflects Echodyne’s continued commitment to: enhancing security and safety as UxS become ubiquitous on the battlefield and in society in general, staying ahead of the accelerating demand in the U.S. and in Allied countries around the globe, and strengthening America’s defense industrial base. Counter-UAS (C-UAS), beyond visual line of sight (BVLOS) operations for drone-as-first-responders (DFR), force protection, border security, and on-the-move (OTM) are among the applications and capabilities driving accele
Americhem Recognized Among Top 5% Globally for Sustainability Performance with EcoVadis Gold Rating11.2.2026 14:00:00 EET | Press release
Americhem, a globally recognized designer and manufacturer of custom color masterbatch, functional additives, engineered compounds, and performance technologies, has earned the EcoVadis Gold rating, placing the company among the top 5% of organizations assessed globally for sustainability performance in their sector. EcoVadis is one of the world’s most widely used business sustainability assessment platforms, evaluating companies across Environment, Labor & Human Rights, Ethics, and Sustainable Procurement. The Gold rating reflects not only the presence of sustainable policies but also the robustness of management systems, documentation, and implementation practices, as evaluated by EcoVadis across Americhem’s global operations. The EcoVadis Gold rating follows Americhem’s prior Silver ratings in recent years and reflects continued strengthening of environmental stewardship, governance, and management systems across the organization. “This recognition reflects how our teams run the bus
4Moving Biotech Announces the Closing of a €12 Million Financing to Advance a First-in-Class DMOAD in Knee Osteoarthritis11.2.2026 13:30:00 EET | Press release
4Moving Biotech (4MB), a clinical-stage biotechnology company and a spin-off of 4P-Pharma, developing a first-in-class disease-modifying osteoarthritis drug (DMOAD) for knee osteoarthritis, today announced the closing of a €12 million financing, completed through a structured and coordinated funding process. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260209500141/en/ Francis Berenbaum (Left) Luc Boblet, Revital Rattenbach, Jérôme Vailland (Right) This financing was secured from a pool of private investors and family offices, who chose to reinforce their commitment by investing directly at the subsidiary level in 4MB. The round includes a combination of equity and loans, reflecting a flexible capital structure aligned with long-term value creation. This closing forms a natural continuum following the €7.6 million France 2030 i-Démo grant announced last year, and the very recent transatlantic extension of the INFLAM-MOTION
Agentic AI Consulting: Sia Accelerates Its Development with More Than 400 Agents on Its Agent Store11.2.2026 13:17:00 EET | Press release
Sia, an international consulting group specializing in strategy, management, and AI, has reached a milestone in its Agentic AI journey. Born in the digital era, the firm now leverages the expertise of more than 3,000 consultants in 19 countries to help organizations scale AI-driven transformation. From GenAI to an Agent Store for All Industries and Functions After unveiling its Generative AI platform to clients in June 2023, the firm announced the launch of its Agent Store in September 2025. Built on a learn-by-design approach, Sia’s Agent Store grew from 50 AI agents to over 400 available for direct consultation, with over a dozen Minimum Viable Products ready for demonstration. Originally introduced as SiaGPT, the platform is now accessible via siagents.ai, reflecting the transition from custom GPTs to fully agentic services. Sia’s AI agents cover a wide range of industries such as Finance, Energy, Public Sector, Healthcare, and Retail and Consumer Goods, and address all corporate fu
BeOne Medicines to Announce Fourth Quarter and Full Year 2025 Financial Results on February 2611.2.2026 13:00:00 EET | Press release
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will report its fourth quarter and full year 2025 financial results on Thursday, February 26, 2026 before the financial markets open. Following the release of the financials, the Company will host a live webcast with management at 8:00 a.m. ET. The live webcast of this event can be accessed from the investors section of the Company’s website at https://ir.beonemedicines.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the Company’s website. About BeOne Medicines BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics thro
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom