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
Venture Global Announces Final Investment Decision and Financial Close for Phase 2 of CP2 LNG13.3.2026 16:23:00 EET | Press release
Today, Venture Global, Inc. (NYSE: VG) is announcing a final investment decision (FID) and successful closing of an $8.6 billion project financing for the second phase of the company’s third project, Venture Global CP2 LNG (CP2). When combined with the Phase One financing for CP2 announced July 2025, this milestone represents the largest standalone project financing in the U.S. bank market.The transaction garnered enormous interest from the world’s leading banks, resulting in over $19 billion of commitments for Phase Two in addition to the previous $34 billion of commitments for Phase One, and required no outside equity investment. “We are extremely proud to have taken FID on the second phase of CP2, our third greenfield project, bringing Venture Global’s executed capital markets transactions to more than $95 billion,” said Venture Global CEO Mike Sabel. “The tireless dedication of our team has enabled us to reach five final investment decisions in less than seven years, positioning us
NIQ Launches Beta of New AI-Powered Analytical Capabilities in Ask Arthur13.3.2026 13:00:00 EET | Press release
NIQ (NYSE: NIQ), a global leader in consumer intelligence, has launched new AI-powered analytical capabilities in beta within Ask Arthur on the NIQ Discover platform. The expanded experience guides users through end-to-end analysis—helping them identify what matters in the data, understand why trends are occurring, and turn insights into clear, shareable narratives with recommended next steps. As organizations navigate increasing data complexity, the ability to move quickly from insight to action has become essential. Ask Arthur helps shorten analytical processes that once took days or weeks into minutes by surfacing the key drivers behind performance changes and generating decision-ready insights directly within Discover. By connecting analysis, explanation, and storytelling in a single experience, users can move seamlessly from understanding what is happening in the data to determining what to do next. “These new analytical capabilities represent an important step forward in how we b
Reply at NVIDIA GTC: Digital Twins and Physical AI Driving the Next Stage of Industrial Value Creation13.3.2026 12:24:00 EET | Press release
Reply [EXM, STAR: REY] will be present at NVIDIA GTC from 16 to 19 March 2026 in San Jose, California, showcasing how companies can optimise production and logistics processes, scale robotics and sustainably increase industrial performance using digital twin technology and physical AI. The conference is regarded as the most important international meeting point for AI developers, researchers and decision makers. This year, more than 30,000 participants from over 190 countries are expected to attend. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260313000399/en/ By attending NVIDIA GTC, Reply is showcasing how digital simulation and physical automation are already being integrated in practice. Projects for the Otto Group and the industrial edge domain show how physical AI and precise digital twins work together to create new opportunities for industrial value generation. The focus will be on two concrete use cases that demon
Klarna Board Chair Michael Moritz Acquires 3.47 Million Shares for $50 Million13.3.2026 12:05:00 EET | Press release
Klarna Group plc (NYSE: KLAR) today discloses the following transactions by the Chair of its Board of Directors and Chief Product & Design Officer, filed with the U.S. Securities and Exchange Commission on Form 3. Share Purchases Michael Moritz, Chairman, through an associated entity, purchased 3,472,845 ordinary shares between March 3 and March 11, 2026, at an aggregate consideration of $49,913,138.73. David Fock, Chief Product & Design Officer, purchased 27,000 ordinary shares on March 9, 2026, for an aggregate consideration of $388,552.14. Share Sales David Sandström, Chief Marketing Officer, sold 32,703 shares on March 9, 2026, pursuant to a Rule 10b5-1 trading plan, established in 2025. David Sykes, Chief Commercial Officer, sold 23,799 shares on March 13, 2026, pursuant to a separately established Rule 10b5-1 trading plan, established in 2025. Form 3 filings for all transactions are available on the SEC's EDGAR database atwww.sec.gov. Forward-Looking Statements This press release
Intertek Launches Comprehensive Digital Product Passport Services13.3.2026 11:00:00 EET | Press release
Intertek, a leading Total Quality Assurance provider to industries worldwide, has announced the launch of its enhanced Digital Product Passport (DPP) suite of services. This includes a comprehensive advisory service designed to help manufacturers, brands and retailers navigate the fast-evolving regulatory and sustainability landscape associated with digital product passports and circular economy compliance. Mark Thomas, Executive Vice President, Global Sustainability, Assurance, Agri World and Food at Intertek, said: “With the introduction of regulatory frameworks for improving the sustainability performance of products, companies are facing mounting pressure to implement robust systems for transparency, traceability and sustainability reporting globally. This shift marks a significant regulatory milestone, requiring organisations to strengthen data governance, engage suppliers more effectively and demonstrate credible, verifiable sustainability performance across the full product life
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