CELLTRION-HEALTHCARE
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].
View source version on businesswire.com: https://www.businesswire.com/news/home/20220817005324/en/
Link:
Social Media:
About Business Wire
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
Brown Brothers Media Acquires European Startup Media Platform Silicon Canals24.11.2025 03:23:00 CET | Press release
Brown Brothers Media, a Singapore-based digital publisher, announces the acquisition of SiliconCanals.com, the European technology startup media platform and community founded by Remco Janssen and operated under Proudly Media. The six-figure, asset-based deal marks a new chapter for the 11-year-old Dutch media brand, which has grown into one of Europe’s leading voices in the startup and innovation ecosystem. Founded in 2014, Silicon Canals has established itself as a go-to source for news and insights on Europe’s tech, venture capital, and startup scene. The acquisition follows recent shifts in the European tech media landscape, including the closure of The Next Web’s editorial operations and MeOut Group’s earlier acquisition of EU-Startups. “After more than a decade building Silicon Canals into a trusted platform connecting Europe’s founders, innovators, and investors, it was time to pass the baton to a full-fledged, long-term media house,” said Remco Janssen, founder and CEO of Proud
IFF Introduces Smart Dosing Robot to Transform Fragrance Production24.11.2025 02:00:00 CET | Press release
New technology delivers quicker, more precise creative sampling for IFF customers across Greater Asia. IFF (NYSE: IFF) — a global leader in flavors, fragrances, food ingredients, health and biosciences, has implemented the Colibri robot in its Chin Bee production facility. This advanced industrial dosing system can produce fragrance sample batches on demand in minutes, reimagining and expediting the fragrance development journey for local, regional and global customers in Greater Asia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251123090457/en/ Photo credit: IFF - Colleagues at IFF Chin Bee with the site's new smart-dosing robot. The new robotic system, installed at the company's cross-category Scent and Taste production plant in Chin Bee, Singapore, accelerates the path from ideation to formulation for fragrance creation. Replacing the previous system, it handles multiple ingredients simultaneously, operates four times
Andersen Consulting tilføjer samarbejdspartneren Cloud2321.11.2025 18:45:00 CET | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Cloud23, en næstegenerations konsulentvirksomhed, der integrerer data og kunstig intelligens med henblik på at drive digital transformation. Cloud23 er baseret i Sydafrika og leverer intelligente, platformsbaserede løsninger til kunder inden for sektorer som finans, telekommunikation, sundhedsvæsen og produktion. Virksomhedens ydelser spænder over Salesforce-rådgivning og -implementering, managed services og ai-strategi, hvilket giver organisationer mulighed for at modernisere kundeengagement, optimere driften og skabe målbare resultater. “Vores mål hos Cloud23 har altid været at forenkle transformation gennem smart, skalerbart design,” udtaler Ram Ramakrishnan, stifter og administrerende direktør for Cloud23. “Vi fokuserer på at afstemme teknologi med formål og levere resultater, der understøtter langsigtet vækst, kundeværdi og innovation. Samarbejdet med Andersen Consulting giver os mulighed for at styrke vores mission og opnå en stø
AI Takes Out the Trash: Largest U.S. Recycling Project to Extend Landfill Life for Virginia Residents21.11.2025 13:30:00 CET | Press release
Southeastern Public Service Authority of Virginia contracts with AMP to cost-effectively process municipal solid waste, boost recycling and landfill diversion rates The Southeastern Public Service Authority of Virginia (“SPSA”), the regional waste authority for South Hampton Roads, has signed a 20-year contract with Commonwealth Sortation LLC, an affiliate of AMP Robotics Corporation (together, “AMP”), to provide solid waste processing services for SPSA’s eight member communities and their 1.2 million residents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120330758/en/ Building on a nearly two-year pilot project in Portsmouth—which featured an AMP ONE™ system capable of processing up to 150 tons of locally sourced municipal solid waste (“MSW”) per day—AMP will now scale its technology region-wide. Under this long-term partnership, which will facilitate the largest recycling project in the country, AMP will deploy addit
RSA Recognized for the Second Consecutive Year in the 2025 Gartner® Magic Quadrant™ for Access Management21.11.2025 13:00:00 CET | Press release
RSA, the security-first identity leader, today announced that RSA® ID Plus has been recognized for the second year in a row in the Gartner® Magic Quadrant™ for Access Management. “The RSA Access Management strategy has never been about being everything to everyone,” said Greg Nelson, RSA CEO. “We specialize in protecting organizations where risk tolerance is at its lowest and security requirements are at their highest. Our focus is intentional: providing security-first access management that supports compliance, ensures resilience, and delivers confidence at scale.” “RSA specializes in the workforce access management use cases where security, compliance, and operational resilience are non-negotiables,” said Jim Taylor, RSA President, Chief Product and Strategy Officer. “Our product development strategy will continue to emphasize the key qualities that highly regulated industries prioritize, including user experience, strong support for workforce management, and intelligent posture mana
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