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
Align Partners Issues Third Public Shareholder Letter and Submits Formal Shareholder Proposals to Coway14.2.2026 13:31:00 EET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Coway Co., Ltd. (“Coway” or the “Company”), has submitted formal shareholder proposals for the Company’s upcoming 37th Annual General Meeting (“AGM”) and issued its third public shareholder letter to Coway’s Board of Directors. Coway is South Korea’s leading home appliance rental platform, supported by a strong global brand and sales network. Since Netmarble became the largest shareholder in 2020, Coway has delivered steady operating growth, with revenue and operating profit increasing at compound annual rates of 8.9% and 7.7%, respectively, reaching KRW 5.0 trillion in revenue and KRW 878.7 billion in operating profit in 2025. However, Coway’s share price remains materially undervalued, declining 16% from 2019 levels as of February 6, 2026, despite a 155% increase in the KOSPI 200 index over the same period. Over this period, valuation multiples have also compressed significantly, with NTM PER declining from 1
HM King Mohammed VI Presides Over the Launch Ceremony of the Aircraft Landing Gear Production Plant Project, Representing an Investment of €280 million by the Safran Group in Morocco13.2.2026 22:10:00 EET | Press release
His Majesty King Mohammed VI, may God assist Him, accompanied by HRH Crown Prince Moulay El Hassan, chaired on Friday at the Royal Palace in Casablanca the presentation and launch ceremony of the project to build a landing gear production factory for Safran in Nouaceur, a project that reinforces Morocco as a destination of choice and a true integrated industrial actor at the heart of the global economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213269786/en/ His Majesty King Mohammed VI, accompanied by HRH Crown Prince Moulay El Hassan, chaired on Friday at the Royal Palace in Casablanca the presentation and launch ceremony of the project to build a landing gear production factory for Safran in Nouaceur Considered one of the largest manufacturing centres in the world for Safran Landing Systems, the plant will represent an investment of more than EUR 280 million, create 500 jobs, and operate on 100% decarbonised energ
Sultan bin Ahmed visits Huawei R&D Centre and SMG in China13.2.2026 19:52:00 EET | Press release
His Highness Sheikh Sultan bin Ahmed bin Sultan Al Qasimi, Deputy Ruler of Sharjah and Chairman of the Sharjah Media Council, visited the Huawei Research and Development Centre and Shanghai Media Group (SMG) in Shanghai, People’s Republic of China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213682693/en/ Sultan bin Ahmed visits Huawei R&D Centre and SMG in China (Photo: AETOSWire) His Highness toured Huawei Village, which spans 2.2 million square metres and comprises over 100 buildings and laboratories, employing more than 30,000 staff. He observed the master plan of the village and its key facilities that support the company’s business strategy and product development. He also reviewed the specifications of the buildings, constructed to the highest standards, and the diverse services provided to employees, including restaurants, cafes, entertainment venues, and rest areas. The center also offers easy access via train
Volue Welcomes TA Associates as New Strategic Investor13.2.2026 12:15:00 EET | Press release
Volue, a global leader in electrification and energy technology, today announced that TA Associates (“TA”), a leading global private equity firm, has joined as a new strategic investor alongside Advent International (“Advent”), Generation Investment Management (“Generation”) and Arendals Fossekompani. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213436945/en/ Over the past 18 months, Volue has undergone a strategic transformation to sharpen its focus on the energy sector. During this period, Volue divested non-core activities and invested in targeted R&D innovation and strategic acquisitions to further position Volue as a leading provider of integrated technology solutions for power trading and generation, grid optimization, and energy market intelligence. Operating at the center of one of the most mission-critical markets of our time, Volue provides technology that enables utilities, grid operators, traders, and energy
ABB strengthens electrical engineering advisory capabilities in Europe with Premium Power acquisition13.2.2026 11:30:00 EET | Press release
ABB today announced it has entered into an agreement to acquire Premium Power, a leading electrical engineering consultancy headquartered near Dublin, Ireland. For more than two decades, Premium Power has established its reputation as a trusted advisor to large customers, particularly in data centers, pharmaceutical manufacturing and other mission-critical sectors where electrical resilience, uptime and regulatory compliance are essential. The transaction is expected to close in the first quarter of 2026. Financial terms were not disclosed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213161407/en/ Paula O'Neill, Managing Director, Premium Power (L) and Owen Flood, Local Division Manager, ABB Electrification Service (R) As demand for electrification accelerates and power systems become more complex due to digitalization, renewable integration and grid constraints, customers increasingly require specialist advisory suppo
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