CELLTRION-HEALTHCARE
19.8.2022 04:49:05 CEST | 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].
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
Philip Morris International Presents its Value Report 2025: change in motion31.3.2026 10:30:00 CEST | Press release
The company’s annual disclosure unveils its Value Plan 2030+ Philip Morris International (NYSE: PM) today released its Value Report 2025, offering a holistic perspective on the company’s approach to sustainable value creation. The report marks the completion of PMI’s 2025 Roadmap, communicating achievements for each aspiration introduced by the company in 2020, and introduces its Value Plan 2030+, set to guide the company’s continued path to sustainable growth. “For more than a decade, PMI has pursued an industry-leading shift away from cigarettes—a transformation that goes far beyond product innovation to encompass how we allocate capital, engage stakeholders, and measure success,” said Jacek Olczak, Group Chief Executive Officer. “‘change in motion’ captures the reality that transformation is not a project with a defined end date, it is the continuous work of improvement, innovation, and adaptation that keeps us relevant and resilient. We transform continuously because markets evolve
BarmeniaGothaer Modernizes Front-to-Back Investment Platform with Bloomberg and Clearwater Analytics31.3.2026 10:00:00 CEST | Press release
Unified data and a total portfolio view across public and private assets improves transparency, risk oversight, and investment decision-making Bloomberg and Clearwater Analytics (NYSE: CWAN) today announced that BarmeniaGothaer Asset Management AG, one of Germany’s top 10 insurance asset managers managing more than 50 billion euros in assets, has gone live on Bloomberg’s buy-side solutions and has selected Clearwater Analytics as its middle- and back-office management platform, including accounting and data management, completing its front-to-back investment transformation across the organization. The merger of Barmenia and Gothaer in 2024 has created the opportunity to successfully unite two distinct technology and data environments, thereby advancing investment management to a new level. By integrating Bloomberg’s buy-side solutions and Clearwater Analytics into its operations, BarmeniaGothaer Asset Management AG is creating a future-proof investment management workflow that meets th
TREASoURcE Final Conference: 14 April 2026, Brussels – Circular Systemic Solutions: From Demos to Deployment31.3.2026 09:32:00 CEST | Press release
The EU-funded project brings policymakers, industry and cities together to discuss how circular economy solutions can scale beyond pilots. The EU-funded TREASoURcE project will present its key results and policy messages at the Final Conference on 14 April 2026 in Brussels, bringing together policymakers, industry representatives, researchers, cities and civil society actors from across Europe. The full-day conference focuses on how circular economy solutions can move from pilot projects to broader deployment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260331360899/en/ Join us in Brussels for the TREASoURcE Final Conference on circular solutions. Over four years, TREASoURcE has developed and tested scalable circular solutions across three value chains: plastics, batteries, and biobased side and waste streams. From demonstrations to deployment: addressing Europe’s scaling challenge The final conference responds to one of
Thermochemical Energy Storage Leader Redoxblox Rebrands as Tempo31.3.2026 09:00:00 CEST | Press release
Breaking the heat barrier: Tempo advances towards commercial rollout of continuously delivered electrified industrial heat at up to 1,200°C Redoxblox, a leader in thermochemical energy storage (TCES) on a mission to electrify the world with technology that shifts the power dynamic, today announced its rebrand to Tempo. The new identity marks the company’s transition from technology development to the commercial scaling of its breakthrough electrified heat platform. The rebrand, developed in partnership with renowned creative agency Red Antler, aligns Tempo’s strategic identity with its unique ability to meet the rigorous demands of heavy industry. The name Tempo is a nod to three core pillars of the company’s value proposition: Temperature leadership, the time-shifting of energy, and the pace of both continuous industrial heat delivery and rapid innovation. “As we move from technical validation toward large-scale commercial rollout, our brand must reflect the scale of the challenge we
Allshares Acquires Technology Company Amalia to Accelerate Innovation in Ownership and Incentive Management31.3.2026 09:00:00 CEST | Press release
Allshares, a global equity and ownership management platform, today announced the acquisition of Amalia, a France-based company specializing in sales commission and performance management software. The acquisition strengthens Allshares' platform, adding a sophisticated, rules-based engine that expands and enhances its end-to-end ownership offering. Founded in 2020, Amalia was built technology-first. Its software is centered on a powerful rules engine that enables intuitive compensation plan design, giving organizations the flexibility to model incentive structures in a fully self-service environment, unlocking new possibilities for incentive management at scale. Supporting more than 40 organizations, including Nespresso, TheFork, and Rakuten, Amalia provides real-time visibility into performance and incentive data, enabling companies to operate complex compensation programs with greater control and efficiency. “From day one, our focus has been to bring clarity to performance-based comp
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