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
Westinghouse and Hungary Establish Landmark Nuclear Fuel Partnership8.11.2025 15:00:00 CET | Press release
First Contract Signed with MVM Group to Deliver VVER-440 Fuel to Paks Nuclear Power Plant Westinghouse Electric Company and MVM Group signed a contract to ensure diversification of fuel supply in Hungary. This partnership brings to Paks Nuclear Power Plant (NPP) reliable supply with Westinghouse VVER fuel, manufactured in Europe. The Westinghouse VVER-440 fuel reload deliveries will start in 2028, subject to licensing activities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251107682814/en/ Westinghouse Nuclear Fuel Senior Vice President Aziz Dag, left, and Károly Mátrai, CEO of the MVM Group, signed the Paks VVER-440 contract, Nov. 7, 2025. “Our agreement with Westinghouse is a clear response to today's energy challenges and further strengthens the role of Hungary's leading base power plant in the domestic energy supply. This strategically important step will make the operation of Paks Nuclear Power Plant safer and more f
OMRON Releases the “Medium-Term Roadmap SF 2nd Stage”8.11.2025 07:00:00 CET | Press release
OMRON (TOKYO: 6645) has announced its “Medium-Term Roadmap Shaping the Future 2nd Stage (“SF 2nd Stage”),” covering from FY2026 to FY2030, on November 7, 2025 (JST). This Roadmap presents the Group’s vision and growth strategies through 2030, which are disclosed on our corporate website. Overview of the “Medium-Term Roadmap SF 2nd Stage” Since April 2024, OMRON has been implementing a Structural Reform Program “NEXT 2025” aimed at rebuilding our foundation for profitability and growth. With the completion of this Program in September 2025, we have shifted into a growth phase and formulated a new Roadmap looking ahead to 2030. This Roadmap identifies Business Portfolio Restructuring as a core strategy. We have defined Thirteen Focus Businesses to drive the Group’s future growth. By accelerating our selection and concentration efforts, we aim to build a “distinctive” business portfolio that maximizes overall Group growth. Furthermore, to maximize the growth potential of our Focus Busines
26th UN Tourism General Assembly kicks off in Riyadh7.11.2025 22:13:00 CET | Press release
UN Tourism marks 50 years of global cooperation as leaders from across the industry gather to shape the future of tourism. His Excellency Ahmed Al Khateeb, Minister of Tourism – “The Kingdom will play an integral part in ensuring one of the world’s most powerful generators of jobs and GDP grows in harmony with the Sustainable Development Goals.” UN Tourism Secretary-General ZurabPololikashvili – “The UN Tourism General Assembly brings together tourism leaders from across the world to set the agenda and build a more innovative and inclusive sector. From Riyadh, we will set the agenda for tourism for the years ahead.” The 26th session of the UN Tourism General Assembly opened today in Riyadh, marking a historic first for the Gulf Cooperation Council (GCC) region and the largest Assembly since UN Tourism was founded 50 years ago. Around 160 delegations from member states including ministers, senior officials, and leaders from across industry and civil society are coming together to celebr
Xsolla Partners With Deloitte Turkiye and Lorien Accelerator as Category Sponsor for Gaming Awards at Fast 50 Türkiye 2025 Program7.11.2025 19:11:00 CET | Press release
Celebrating Turkey’s Gaming Industry with High-Impact Sponsorship and Industry Panel Xsolla, a leading global video game commerce company that helps developers launch, grow, and monetize their games, is proud to announce its sponsorship of the Gaming Awards segment at the Deloitte Technology Fast 50 Türkiye 2025 Program, organized in collaboration with Lorien Accelerator. The event will take place on December 10, 2025, and will recognize Turkey’s top high-growth companies across various industries, with a special focus on the dynamic gaming sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251107671030/en/ Graphic: Xsolla As the Gaming Awards category sponsor, Xsolla will receive significant brand exposure through prominent logo placements across all event materials, including digital platforms, official event signage, and other promotional materials. In addition to this visibility, Xsolla’s participation includes an ex
Takeda Presents New Data Showing Mezagitamab (TAK-079) Sustained Effect on Kidney Function 18 Months After Treatment in Primary IgA Nephropathy7.11.2025 17:00:00 CET | Press release
− Phase 1b, Open-Label Study Follow Up Shows Stable Kidney Function (eGFR) in Patients Treated with Investigational Mezagitamab Through Week 96 – 18 Months After Last Dose1− Rapid Reductions in Proteinuria and Serum Gd-IgA1 Levels Were Sustained Through Week 961− No Serious Adverse Events or Opportunistic Infections Were Observed Through Week 961− Takeda Initiated Pivotal Phase 3 Clinical Trials Evaluating Mezagitamab in Primary IgA Nephropathy and Immune Thrombocytopenia with Patient Enrollment Ongoing Takeda (TSE:4502/NYSE:TAK) today announced new interim data from the Phase 1b, open-label, proof-of-concept study of subcutaneous mezagitamab (TAK-079), an anti-CD38 monoclonal antibody with disease-modifying potential, in primary immunoglobulin A (IgA) nephropathy. Data from the study showed that kidney function (eGFR) remained stable in patients with IgA nephropathy through Week 96 – up to 18 months after the last mezagitamab dose.1 The results were presented at the American Society o
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