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
WHOOP Raises $575 Million at $10.1 Billion Valuation to Advance Global Health Platform31.3.2026 13:00:00 EEST | Press release
WHOOP, the human performance company, today announced it has raised $575 million in Series G funding at a $10.1 billion valuation, advancing its global expansion and long-term vision for personalized health. The round was led by Collaborative Fund and includes global participation from 2PointZero Group, Qatar Investment Authority (QIA), Mubadala Investment Company, Abbott, Mayo Clinic, Macquarie Capital (entities administered by Macquarie Capital), Glade Brook, B-Flexion, IVP, Foundry, Accomplice, Affinity Partners, Promus Ventures, and Bullhound Capital alongside a group of prominent global athletes and individual investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260331399622/en/ WHOOP Raises $575 Million at $10.1 Billion Valuation to Advance Global Health Platform Individual investors in the round include Cristiano Ronaldo, LeBron James, Rory McIlroy, Reggie Miller, Niall Horan, Karen Wazen, Virgil van Dijk, Mathie
CORRECTING and REPLACING Lenovo Announces Global Partnership With David Beckham31.3.2026 12:28:00 EEST | Press release
Last paragraph before boilerplate should read: “David is not only a global figure across football, business, and culture, but is someone who understands the power of innovation to transform the world. That makes him the perfect partner to help us demonstrate how Smarter AI can drive better life and more efficient work for all." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330443523/en/ Lenovo Announces Global Partnership With David Beckham The updated release reads: LENOVO ANNOUNCES GLOBAL PARTNERSHIP WITH DAVID BECKHAM Lenovo today announced a global partnership with David Beckham, bringing together one of the world’s most recognized cultural figures and one of the world’s leading technology companies. The collaboration builds on Lenovo’s expanding role in global football, including its position as the Official Technology Partner of FIFA World Cup 2026™ and the FIFA Women’s World Cup 2027™. This first of its kind Lenov
Interactive Brokers Launches Crypto-Asset Trading for Individual Investors in the European Economic Area31.3.2026 12:00:00 EEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the launch of crypto-asset trading for eligible individual investors in the EEA through Interactive Brokers Ireland Limited, which is an authorised crypto-asset service provider in the EEA. Many European investors face challenges managing multiple crypto apps, understanding unclear fees, or navigating security concerns. Interactive Brokers now offers a solution. Starting today, eligible individual investors in the EEA can trade 11 leading crypto-assets directly on the same platform they already use for stocks, options, futures, currencies, bonds, and mutual funds. This integrated approach gives clients a unified view of their entire portfolio. With one login, they can manage both traditional and crypto-assets, backed by the control, low pricing, and global reach that Interactive Brokers is known for. “Our clients want the flexibility to diversify into crypto-assets while maintaining the tools, pricing, and
Philip Morris International Presents its Value Report 2025: change in motion31.3.2026 11:30:00 EEST | Press release
Philip Morris International (NYSE: PM) today released its Value Report 2025, offering a holistic perspective on the company’s approach to sustainable value creation. The report marks the completion of PMI’s 2025 Roadmap, communicating achievements for each aspiration introduced by the company in 2020, and introduces its Value Plan 2030+, set to guide the company’s continued path to sustainable growth. “For more than a decade, PMI has pursued an industry-leading shift away from cigarettes—a transformation that goes far beyond product innovation to encompass how we allocate capital, engage stakeholders, and measure success,” said Jacek Olczak, Group Chief Executive Officer. “‘change in motion’ captures the reality that transformation is not a project with a defined end date, it is the continuous work of improvement, innovation, and adaptation that keeps us relevant and resilient. We transform continuously because markets evolve, science advances, stakeholder expectations rise, and new op
BarmeniaGothaer Modernizes Front-to-Back Investment Platform with Bloomberg and Clearwater Analytics31.3.2026 11:00:00 EEST | Press release
Bloomberg and Clearwater Analytics (NYSE: CWAN) today announced that BarmeniaGothaer Asset Management AG, one of Germany’s top 10 insurance asset managers managing more than 50 billion euros in assets, has gone live on Bloomberg’s buy-side solutions and has selected Clearwater Analytics as its middle- and back-office management platform, including accounting and data management, completing its front-to-back investment transformation across the organization. The merger of Barmenia and Gothaer in 2024 has created the opportunity to successfully unite two distinct technology and data environments, thereby advancing investment management to a new level. By integrating Bloomberg’s buy-side solutions and Clearwater Analytics into its operations, BarmeniaGothaer Asset Management AG is creating a future-proof investment management workflow that meets the organization’s efficiency goals in an increasingly dynamic capital market, and provides cutting-edge technologies for the entire investment l
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