European Commission approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the treatment of multiple types of cancer

European Commission approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the treatment of multiple types of cancer

·         Vegzelma™ offers European patients living with certain types of breast, lung, renal, colon, rectum, ovarian and cervical cancers a new, safe, and effective treatment option at an affordable price 

·         Approval is based on clinical trial data demonstrating Vegzelma™ is highly similar to Avastin^®[i] (bevacizumab)

·         Vegzelma™ is Celltrion’s third oncology biosimilar approved by the European Commission

FRIDAY 19 AUGUST, 2022 - INCHEON, SOUTH KOREA – 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.[ii]

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.

[i] Avastin^® is a registered trademark of Genentech Inc.

[ii] 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.