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
Cyclic Materials Secures USD $75M Series C Funding to Fast-Track Local and Resilient Rare Earths Supply at Global Scale23.1.2026 13:00:00 CET | Press release
New equity investment will accelerate deployment of resilient, locally anchored rare earths recycling infrastructure enabling new streams of heavy rare earths supply for AI, robotics, defense and advanced manufacturing critical to the future of Western industry Cyclic Materials today announced it has closed an over-subscribed USD $75 million Series C equity round, its largest to date, scaling up operations across the US and Europe and accelerating Canada-based research and development footprint. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260123519008/en/ Cyclic Materials’ Mesa, Arizona site, the very first scale-up of a commercial plant for recycling and local production of rare earths in the US, with a focus on heavy and light rare earth magnets. The recycling of magnet-containing end-of-life (EOL) scrap and magnet production waste is the fastest way to the production of magnet rare earth elements (REEs) in Western coun
SLB Announces Fourth-Quarter and Full-Year 2025 Results, Increases Dividend and Commits to Return More Than $4 Billion to Shareholders in 202623.1.2026 12:50:00 CET | Press release
Fourth-quarter revenue of $9.75 billion increased 9% sequentially and 5% year on year Fourth-quarter GAAP EPS of $0.55 increased 10% sequentially and decreased 29% year on year Fourth-quarter EPS, excluding charges and credits, of $0.78 increased 13% sequentially and declined 15% year on year Fourth-quarter net income attributable to SLB of $824 million increased 12% sequentially and decreased 25% year on year Fourth-quarter adjusted EBITDA of $2.33 billion increased 13% sequentially and decreased 2% year on year Fourth-quarter cash flow from operations was $3.01 billion and free cash flow was $2.29 billion Board approved a 3.5% increase in quarterly cash dividend to $0.295 per share Full-year revenue of $35.71 billion decreased 2% year on year Full-year GAAP EPS of $2.35 decreased 24% year on year Full-year EPS, excluding charges and credits, of $2.93 decreased 14% year on year Full-year net income attributable to SLB of $3.37 billion decreased 24% year on year Full-year adjusted EBIT
“And I Chose to Live” The Blind Sailor Mitsuhiro Iwamoto Takes the Stage at WEF23.1.2026 09:00:00 CET | Press release
- “HIRO’s CHOICE”: A Solo, Non-Stop Crossing of the Pacific Ocean- Mitsuhiro Iwamoto, a blind Japanese sailor based in San Diego, delivered a speech at the World Economic Forum Annual Meeting 2026 on January 21 (local time). He is undertaking the world’s first solo, non-stop trans-Pacific crossing by a blind person as part of the “Blind Sailor Single-Handed Pacific Crossing Project 2027.” WEF URL: https://www.weforum.org/ This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260121469502/en/ Hiro Iwamoto / Global Keynote Speaker, First Totally Blind Sailor to Cross the Pacific In the spring of 2027, he will attempt a solo, non-stop trans-Pacific crossing, sailing a 28-foot yacht single-handedly from San Diego on the U.S. West Coast to Amakusa, Kumamoto Prefecture, Japan, without making any port calls. Project URL: https://hiros-choice.com/ The theme of his speech was “Sailing Through Barriers.” He spoke about how, since losing his
BitGo Holdings fejrer sin børsnotering på New York Stock Exchange23.1.2026 03:52:00 CET | Pressemeddelelse
BitGo Holdings, Inc. ("BitGo", "virksomheden", "vi"), en virksomhed inden for digital infrastruktur til aktiver, fejrer i dag sin lancering på New York Stock Exchange ("NYSE") som et børsnoteret selskab under tickersymbolet "BTGO". Medlemmer af BitGos ledelsesteam vil i dag kl. 09:30 ET ringe med åbningsklokken på NYSE. "I dag markerer et afgørende øjeblik for BitGo," udtaler Mike Belshe, administrerende direktør og medstifter af BitGo. "Vores indtræden på de offentlige markeder vil gøre det muligt for os yderligere at accelerere det finansielle systems overgang til en gennemsigtig og troværdig digital aktivøkonomi, samtidig med at vi fortsat kan levere enestående sikkerheds-, depot- og likviditetsløsninger til vores kunder. Vi er overbeviste om, at potentialet forude er stort, og at vi er unikt positioneret til at hjælpe institutioner med at gå fremtiden i møde." Belshe fortsætter: "Jeg er utroligt stolt af den virksomhed, vi har opbygget, og dybt taknemmelig for vores teams hårde arb
Tinaba with Banca Profilo Strengthens Its Global Positioning and Launches Digital Payments in the Chinese Mainland with Alipay+23.1.2026 02:41:00 CET | Press release
Through the “Pay Worldwide with Alipay+” feature available in the App, users can pay in the Chinese mainland at over 80 million merchants Tinaba with Banca Profilo announces the launch of digital payments in the Chinese mainland through the extension of its strategic partnership with Alipay+, Ant International’s global wallet gateway solution, bringing a simple, cashless and local payment experience to Italian travellers in the world’s largest digital market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260122062969/en/ Matteo Arpe, President of Tinaba with Banca Profilo, announces the expanded partnership with Alipay+ in Milan, Italy Starting today, users can pay in the Chinese mainland at over 80 million merchants simply by scanning a QR code directly from the Tinaba App. This innovation is particularly significant in a country where digital payments are the everyday standard and cash is increasingly less used. The servi
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