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
Haleon Strengthens Commitment to China as Consumers Focus on Better Everyday Health11.3.2026 11:00:00 EET | Press release
Haleon, a consumer company that is solely focused on better everyday health, is investing £65 million in a new state-of-the-art oral health manufacturing site in Shanghai. The facility will support the expansion of its oral care portfolio – which includes the global brands Sensodyne and parodontax – into China’s fast-growing tier 2 and tier 3 cities, where rising incomes, growing awareness of everyday health and a shift towards trusted, branded products are reshaping consumer behaviour. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311389622/en/ parodontax, Haleon's clinically proven gum health brand, is expanding across China As part of this shift, more consumers are embedding preventative oral care into their daily self-care routines, and demand for premium, science-backed solutions is accelerating at a rapid pace. This investment strengthens Haleon’s local manufacturing footprint and positions the business to capture
Eurofins Biomnis Launches New Clinical LC‑MS/MS Method for the Detection of Cereulide Toxin in Stool Samples11.3.2026 10:00:00 EET | Press release
Eurofins Biomnis, a leading European provider of specialised clinical diagnostics services, and part of the global network of Eurofins laboratories, announces the successful development and validation of a new liquid chromatography tandem mass spectrometry (LC‑MS/MS) method for the detection and quantification of cereulide toxin in human stool samples. This innovation underlines Eurofins Biomnis’ diagnostic innovation, and its commitment to contributing its expertise to reducing diagnostic uncertainty with solutions that support clinicians and laboratories nationwide and internationally. Eurofins Biomnis has fully validated the method for human stool samples, taking into account matrix effects and meeting the requirements of ISO 15189 (with the exception of inter‑method comparison on pathological clinical samples). Cereulide, a toxin produced by specific strains of Bacillus cereus, has recently raised significant public attention following contamination events involving infant formula
1NCE and Netmore Combine Cellular and LoRaWAN Access to Deliver Global IoT Coverage11.3.2026 09:40:00 EET | Press release
1NCE, a company offering a plug-and-play platform for creating and managing the world’s best IoT products, today opened access for its customers to the LoRaWAN® services of Netmore, the world’s leading low power wide area network operator for massive IoT. With growing demand for low power long range connectivity, the Netmore LoRaWAN Network Server (LNS) Plugin provides 1NCE customers access to cellular and LoRaWAN IoT coverage options through one platform. The launch of the Netmore Plugin marks the beginning of strategic collaboration to expand the combined offering of the two biggest massive IoT network specialists — 1NCE, the biggest private IoT network in the cloud and Netmore, the largest LoRaWAN network and platform provider in the world. 1NCE’s software and connectivity platform has become a new industry standard. Working together to support their respective customer bases with both cellular and LoRaWAN technology delivers a powerful layer of redundancy to cover the hardest to re
1NCE and Netmore Combine Cellular and LoRaWAN Access to Deliver Global IoT Coverage11.3.2026 09:40:00 EET | Press release
1NCE, a company offering a plug-and-play platform for creating and managing the world’s best IoT products, today opened access for its customers to the LoRaWAN® services of Netmore, the world’s leading low power wide area network operator for massive IoT. With growing demand for low power long range connectivity, the Netmore LoRaWAN Network Server (LNS) Plugin provides 1NCE customers access to cellular and LoRaWAN IoT coverage options through one platform. The launch of the Netmore Plugin marks the beginning of strategic collaboration to expand the combined offering of the two biggest massive IoT network specialists — 1NCE, the biggest private IoT network in the cloud and Netmore, the largest LoRaWAN network and platform provider in the world. 1NCE’s software and connectivity platform has become a new industry standard. Working together to support their respective customer bases with both cellular and LoRaWAN technology delivers a powerful layer of redundancy to cover the hardest to re
Codethink Opens Early Access to IEC 61508 Mapping for the Eclipse Trustable Software Framework11.3.2026 09:07:00 EET | Press release
EMBEDDED WORLD--Codethink today opened early access to its mapping between the Eclipse Trustable Software Framework (TSF) and IEC 61508, the international standard governing the functional safety of electrical and electronic systems. The mapping establishes a transparent relationship between the engineering principles of the Trustable Software Framework and the objectives defined in IEC 61508. By making this work available as an early preview, Codethink is inviting organisations interested in applying open source approaches to functional safety to review and begin working with the mapping while the work continues to mature. IEC 61508 forms the foundation of many domain-specific safety standards, including ISO 26262 for automotive systems. The early access reflects Codethink’s long-standing commitment to open development of software engineering methods. “This preview release reflects our belief that trust in software must be engineered in the open," said Paul Sherwood, Codethink’s Chair
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