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
Horizon3 and Pax8 Expand Partnership to Bring Autonomous Security Testing to MSPs Across Europe16.10.2026 09:03:00 EEST | Press release
Horizon3, the AI-Native Proactive Security Company, today announced the expansion of its Pax8 partnership across Europe, bringing the NodeZero® Proactive Security Platform to the region’s managed service providers (MSPs) through the Pax8 Marketplace. The expansion enables partners to build recurring security services that help small and midsized businesses understand how attackers could compromise their environments, prioritize corrective actions, and verify remediation. Building on the companies’ North American marketplace launch, the European expansion makes autonomous offensive security testing accessible to more MSPs and the businesses they protect. Partners can use NodeZero to deliver initial assessments, support remediation engagements, and establish ongoing testing programs without conducting every penetration test manually. “MSPs are accountable for protecting their customers’ security, but a list of vulnerabilities does not tell them what is actually exploitable, and their lev
MSCI Launches a Consultation on a Proposal to Reclassify Indonesia from Emerging Market to Standalone Market Status16.10.2026 00:47:00 EEST | Press release
MSCI announced the launch of a consultation on a proposal to reclassify the MSCI Indonesia Indexes from Emerging Market to Standalone Market status. MSCI will announce its final decision by the end of June 2027 and may provide an interim update on market participant feedback during the consultation period. As part of the June 2026 Market Classification Review, MSCI reported that market participants had raised significant concerns regarding the investability of the Indonesian equity market, including persistent opacity in shareholding structures and suspected coordinated trading behavior. While the Indonesian authorities have announced reforms, including enhanced disclosure of shareholders with ownership above 1%, more granular investor classification disclosure, High Shareholding Concentration (HSC) reporting, and a roadmap towards a minimum free float requirement of 15%, institutional investors have emphasized the need for consistent implementation and evidence of sustained material i
Nekome: Nazi Hunter Unmasks Hitler’s Hyenas in New Trailer Ahead of Steam Next Fest Demo15.10.2026 22:38:00 EEST | Press release
ProbablyMonsters, an independent video game company creating original AA games with AAA sensibilities, today unveiled a new trailer for Nekome: Nazi Hunterat the Galaxies Autumn Showcase, pulling back the curtain on the game’s villains, Hitler’s Hyenas. Alongside the new trailer, ProbablyMonsters announced that Nekome: Nazi Hunter will participate in October’s Steam Next Fest, giving players their first opportunity to experience this violent odyssey of revenge with a free PC demo available on Steam from October 19 through 26. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014661905/en/ “Nekome is Vano’s story: an exploration of a young Romani man who has had everything taken away from him, and who decides to pick up a knife and exact revenge on his family’s murderers,” said Jeronimo Barrera, ProbablyMonsters’ General Manager and Game Director. “Each of Hitler’s Hyenas brandishes their own form of evil and presents a new a
The Estée Lauder Companies Announces BEAUTY&YOU India 2026 Winners and Marks Five Years of Advancing Indian Beauty Entrepreneurship15.10.2026 18:58:00 EEST | Press release
The Estée Lauder Companies, in partnership with Nykaa and Startup India, an initiative of the Department for Promotion of Industry and Internal Trade (DPIIT) within India’s Ministry of Commerce and Industry, announced the winners of BEAUTY&YOU India 2026, the country’s leading beauty entrepreneurship program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015612324/en/ (L to R) BEAUTY&YOU India 2026 Winners Ajaykumar Mehta, Shriya Rambhia, and Dheer Rambhia, Directors, Goyam Green Tech (BREAKTHROUGH), Nirja Bhatt, Founder & CEO, Laani (GROW), Khatija Shabana, CEO, and Syed Mohammad Fouzan, Director, Boldpurity (IMAGINE), Rinzing Choden Bhutia, Founder, Agapi Sikkim (Visionary Women’s Award), and Pankti Sheth, Founder & Creative Director, De Icebreaker Creative Studio (DESIGN). For five years, BEAUTY&YOU India has discovered, supported, and accelerated India’s next generation of beauty entrepreneurs. Since launching in 202
BioLab Holdings Launches EmeraNova™ to Advance the Future of Tissue Restoration15.10.2026 18:00:00 EEST | Press release
BioLab Holdings announced today a new, larger mission with the launch of EmeraNova™, a new corporate identity that reflects a broader ambition to advance tissue restoration across specialties, healing phases, and care settings. The launch marks the company’s efforts to build a global platform focused on identifying promising technologies and accelerating their path into clinical practice. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015721831/en/ EmeraNova seeks partners around the world to bring promising technologies to market quickly and equip clinicians with advanced, effective solutions. EmeraNova represents a vision to pursue emerging (Emer) and new (Nova) technologies by building an expanding toolbox of tissue restoration solutions, world-class support, and ways to bring together expert voices and clinical insights that will help shape what comes next. The company’s roots in chronic wound care will inform its fut
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