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
Biocytogen and Acepodia Expand Collaboration Through Option-based Evaluation Framework for First-in-Class Bispecific and Dual-Payload ADCs (BsAD2C)9.1.2026 14:00:00 EET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315) and Acepodia (6976:TT), today announced that the companies have entered into an option and license agreement designed to enable the structured evaluation of bispecific antibody-drug conjugate (BsADC) programs to further advance the development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs). The agreement grants Acepodia an option to obtain an exclusive worldwide license from Biocytogen for two BsADC programs. Under the terms of the agreement, Biocytogen is eligible to receive an upfront option fee and, upon Acepodia’s exercise of the option, additional payments including option exercise fees, development, regulatory, and commercial milestone payments, as well as royalties on future product sales. The financial terms of the agreement were not disclosed. “This new agreement builds upon our recent co-development collaboration with Acepodia, which has focused on the evaluation and selection
Blockstream Capital Partners Announces Strategic Acquisition of Derivatives Trading Team from Numeus Group, Leveraging Strategic Partnership with Komainu9.1.2026 12:08:00 EET | Press release
Blockstream Capital Partners (“BCP”) today announced that it has entered into a strategic agreement to acquire a division within Numeus Group’s digital asset trading and investment business. The transaction includes the absorption of select Bitcoin focused trading strategies with a focus on yield generation as well as a ten person derivatives trading team led by Chief Investment Officer Deepak Gulati, a specialist in volatility and derivatives markets. Deepak Gulati, appointed Co-Chief Investment Officer of Blockstream Capital Management alongside Rodrigo Rodriguez, previously served as Global Head of Proprietary Trading at JPMorgan, before founding Argentiere Capital, a multibillion-dollar volatility-focused hedge fund. With a thesis that derivatives would drive Bitcoin and digital asset market maturity, he co-founded Numeus Group in 2021 to develop institutional-grade trading, risk management and market-structure capabilities. Komainu, an existing BCP strategic investment, has played
Autel Unveils Strategic Shift at CES 2026: Building the AI-Powered Infrastructure of Future Cities9.1.2026 11:44:00 EET | Press release
At the Consumer Electronics Show (CES), Autel Energy is presenting its latest AI-driven smart hardware and software systems for the future of intelligent urban operations. This year’s showcase highlights Autel’s shift from AI concept validation to scenario-based engineering deployment, emphasizing closed-loop execution across real-world infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260101511436/en/ Autel Energy New Product Debut at CES 2026 Focusing on two key domains — Smart Energy and Smart Inspection — the company is unveiling a range of new products. In Smart Energy, Autel is introducing V2G (Vehicle-to-Grid) AC charger for homes and DC charging solution for fleets, strengthening its multi-tier energy touchpoint strategy from households to commercial operations. Live demonstrations at the booth will feature a smart charging robot showcasing automated plug-in capabilities. In Smart Inspection, Autel will
Allianz and Anthropic Forge Global Partnership to Advance Responsible AI in Insurance9.1.2026 11:00:00 EET | Press release
Allianz SE and Anthropic today announced a global partnership to accelerate the adoption of responsible Artificial Intelligence (AI) at Allianz. The collaboration centers on three transformative projects within Allianz Group designed to empower Allianz employees and accelerate operations, while setting new benchmarks for accuracy. “With this partnership, Allianz is taking a decisive step to address critical AI challenges in insurance. Anthropic’s focus on safety and transparency complements our strong dedication to customer excellence and stakeholder trust. Together, we are building solutions that prioritize what matters most to our customers while setting new standards for innovation and resilience,” said Oliver Bäte, CEO of Allianz SE. “Insurance is an industry where the stakes of using AI are particularly high: the decisions can affect millions of people. Allianz and Anthropic both take that very seriously, and we look forward to working together to make insurance better for those w
MRM Health Secures FDA IND Clearance to Launch its Phase 2b Trial of MH002 in Mild-to-Moderate Ulcerative Colitis9.1.2026 08:00:00 EET | Press release
MRM Health NV, a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory diseases and immune-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its lead program MH002. This enables the initiation of the STARFISH-UC Phase 2b clinical trial in patients with mild-to-moderate ulcerative colitis, marking a significant step forward in the development of next-generation therapies for inflammatory bowel diseases (IBD). About the STARFISH-UC Phase 2b Trial The STARFISH-UC trial is a randomized, double-blind, placebo-controlled study designed to confirm the promising efficacy signals and favorable safety profile previously observed in MH002’s Phase 2a studies. MH002, a rationally designed live microbial consortium, is the most advanced Live Biotherapeutic Product (LBP) of its kind, targeting disease-specific mechanisms through a synergistic combination of
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