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
Uniswap Labs and Securitize Collaborate to Unlock Liquidity Options for BlackRock’s BUIDL11.2.2026 16:00:00 EET | Press release
Uniswap Labs, the leader in decentralized finance, and Securitize, the leader in tokenizing real-world assets (RWAs), today announced a strategic integration to make BlackRock USD Institutional Digital Liquidity Fund (BUIDL) shares available to trade via UniswapX technology. This integration will enable onchain trading of BUIDL, both unlocking new liquidity options for BUIDL holders, and marking a significant step in bridging the gap between traditional finance and DeFi. “Our mission at Labs is simple: make exchanging value cheaper, faster and more accessible,” said Hayden Adams, Uniswap Labs Founder and CEO. “Enabling BUIDL on UniswapX with BlackRock and Securitize supercharges our mission by creating efficient markets, better liquidity, and faster settlement. I’m excited to see what we build together.” Securitize Markets will facilitate trading for any BUIDL investor who elects to participate through UniswapX’s RFQ framework. The automated system enables participants to identify the
Energy Vault and Crusoe Announce Strategic Framework Agreement for Deployment of Crusoe Spark Modular AI Factory Units to Deliver Crusoe Cloud11.2.2026 15:30:00 EET | Press release
Energy Vault Holdings, Inc. (NYSE: NRGV) (“Energy Vault”), a global leader in grid-scale energy storage solution infrastructure, and Crusoe, the industry’s first vertically-integrated AI infrastructure provider, today announced a strategic framework agreement for the phased deployment of Crusoe Spark modular data centers at Energy Vault’s technology center in Snyder, Texas. The initial program is scalable up to 25 megawatts (MW) of total load to be operated inside Crusoe’s proprietary Spark modular AI factory product. The companies plan to begin deployments in 2026, enabling Crusoe Cloud to expand available computing capacity, including its new Managed Inference services, to meet customer demand. The initiative represents a significant expansion of Crusoe’s Spark program, a demonstration of rapidly deployable modular AI inference capacity, and a continuation of Crusoe’s commitment to innovative energy-first AI infrastructure development. This press release features multimedia. View the
Corpay Cross-Border Extends Exclusive Partnership with LIV Golf11.2.2026 15:30:00 EET | Press release
Corpay, Inc.* (NYSE: CPAY), a global leader in corporate payments, today announced that its Cross-Border business has entered into a multi-year agreement to extend its successful and exclusive collaboration with LIV Golf, as its Official Corporate Foreign Exchange (FX) Provider. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211636852/en/ Since 2024, Corpay Cross-Border has delivered a range of corporate foreign exchange payment solutions to LIV Golf. With this multi-year extension, the League will continue to benefit from Corpay’s comprehensive currency risk management solutions and award-winning global payments platform. “Over the past two seasons, we’ve had the privilege of being the Official Corporate FX Provider for LIV Golf,” said Brad Loder, Chief Marketing Officer, Corpay Cross-Border Solutions. “We take great pride in the trust that the League’s Finance and Partnership teams have placed in us, and we are thrilled
Calvin McDonald Joins The Wella Company as CEO11.2.2026 15:30:00 EET | Press release
The Wella Company, an innovative global beauty leader, today announced that Calvin McDonald has been chosen as the company’s next Chief Executive Officer, effective April 2, 2026. Calvin will also be appointed to the company’s Board of Directors and will be based in New York. Glenn Murphy will remain as Executive Chair to provide continuity as well as strategic advice to the new CEO and the leadership team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260210093439/en/ Calvin McDonald “We are delighted to welcome Calvin to The Wella Company,” said Glenn Murphy, Executive Chair. “As a three-time CEO, he brings decades of experience at industry-leading global consumer brands and retail businesses. Calvin’s proven ability to drive results through product differentiation, category expansion, and smart investments will help us win in the dynamic beauty sector.” Under KKR’s ownership, The Wella Company has been transformed into a
INNIO Secures Additional Major Order from VoltaGrid: 1.5 GW for Behind-the-Meter Power Generation11.2.2026 15:00:00 EET | Press release
INNIO Group today announced a major order from VoltaGrid for 1.5 gigawatts (GW), reinforcing the companies’ collaboration in behind‑the‑meter (on-site) power generation for AI and high‑performance computing infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211822384/en/ INNIO's Jenbacher J624 gas engine Under the agreement, INNIO expects to supply a total of 300 Jenbacher gas engines from its Type J624 and Type J620 series. The J624 series is integrated into VoltaGrid’s proprietary QPac™ platform. The engines are packaged into 25 MW units, enabling rapid, scalable deployment for data center customers across the United States. Delivery is scheduled by 2028. “This landmark order underscores the strength of INNIO’s technology and our commitment to power the growth of AI,” said Dr. Olaf Berlien, President and CEO of INNIO Group. “We are proud to deepen our collaboration with VoltaGrid as we help shape the evoluti
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