European Commission Approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer
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
OPPO Joins VVC Advance Patent Pool as a Licensee and Extends HEVC Advance License9.1.2026 04:00:00 EET | Press release
Access Advance LLC and Guangdong OPPO Mobile Telecommunications Corp., Ltd. (OPPO) today announced that OPPO has joined the VVC Advance Patent Pool as a Licensee and renewed its HEVC Advance License. OPPO, one of the world's largest smartphone manufacturers with operations in more than 70 countries, has been a valued participant in Access Advance's HEVC patent pool since 2020, and more recently joined the Advance Video Distribution Patent (VDP) Pool as a Licensor. These latest agreements mark a new milestone in a broad and deepening relationship between the two companies, with OPPO now participating across all three of Access Advance's video codec licensing programs. The VVC Advance Patent Pool licenses patents essential to the VVC/H.266 standard, which delivers remarkable improvement of video compression performance over HEVC, enabling higher-quality video experiences including 4K, 8K, and HDR content with faster downloads and lower latency. The pool currently includes over 4,500 worl
Cessna Citation CJ3 Gen2 Enters Into Service, Delivering the Most Significant Gen2 Updates to Date8.1.2026 23:30:00 EET | Press release
The Cessna Citation CJ3 Gen2 has entered into service, setting a new standard for the Citation Gen2 family. Launch customers and longtime Citation owners Dave Mecartney and Shannon Day took delivery of their new aircraft this week. Mecartney—an experienced aviator with nearly two decades flying Citation light jets and a member of Textron Aviation’s Customer Advisory Board—helped shape the enhancements that elevate the CJ3 Gen2 experience. Key upgrades include Garmin autothrottle technology, added pilot legroom and a fully customizable cabin environment, all driven by customer feedback. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108455097/en/ Cessna Citation CJ3 Gen2 enters into service, delivering the most significant Gen2 updates to date (Photo credit: Textron Aviation). The Cessna Citation CJ3 Gen2 is designed and manufactured by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company. “The Citation CJ3 Gen2 deliv
SPIE, the International Society for Optics and Photonics, Announces Its 2026 Society Awards8.1.2026 19:26:00 EET | Press release
Today, the Awards Committee of SPIE, the international society for optics and photonics, announced the recipients of its prestigious annual awards. Honoring transformative advancements across a range of professional areas — including medicine, astronomy, lithography, optical metrology, optical design, and community leadership — the Society's awards recognize technical accomplishments as well as committed service to SPIE and support of its organizational mission. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108227351/en/ SPIE, the international society for optics and photonics, awarded their Gold Medal to Maryellen Giger (pictured here with her team) for pioneering work in computer-aided diagnosis and image analysis/AI, significant impact on clinical translation, and supporting the next generation of medical-imaging scientists and the SPIE community. SPIE Gold Medal: Maryellen Giger For pioneering work in computer-aided
PUMA Appoints Nadia Kokni as Vice President Global Brand Marketing8.1.2026 17:30:00 EET | Press release
Sports company PUMA has appointed Nadia Kokni as Vice President, Global Brand Marketing, effective January 1, 2026. Nadia joins PUMA’s global leadership team and reports directly to Chief Brand Officer Maria Valdes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108099913/en/ Sports company PUMA has appointed Nadia Kokni as Vice President, Global Brand Marketing, effective January 1, 2026. Nadia joins PUMA’s global leadership team and reports directly to Chief Brand Officer Maria Valdes. In her new role as PUMA’s most senior global marketing leader, Nadia will oversee brand marketing strategy, brand marketing creative direction, integrated marketing and communication globally. Her appointment comes as PUMA accelerates its global brand ambition and sharpens storytelling around its product icons and innovation pipeline. Nadia brings deep international experience shaping and transforming leading global brands across the spor
Xsolla Kicks Off Two Weeks of Industry Programming, Community Events, and Expanding Support for Global Developers Across the UK at the Industry’s Biggest Winter Event8.1.2026 17:00:00 EET | Press release
Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, today announces a comprehensive program of events and activations across the United Kingdom taking place from January 10 to 22, 2026. This coordinated programming schedule reflects Xsolla’s continued investment in the UK and European games ecosystem. Capitalizing on a pivotal moment in the global games calendar, Xsolla is bringing developers, partners, and creators together through partnerships, live events, thought leadership, and community building. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108943976/en/ (Graphic: Xsolla) “Pocket Gamer Connects London brings together one of the most diverse and forward-thinking communities in the mobile global games industry,” said Berkley Egenes, Chief Marketing and Growth Officer. “We’re here to build all the things for the video game industry by helping developers turn grea
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