Celltrion Healthcare today received European Commission (EC) approval for Vegzelma ® (CT-P16). Vegzelma ® is a bevacizumab biosimilar that is highly comparable to the EU-approved reference drug Avastin ® . Approval was granted for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced 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 improve access to treatment for patients suffering from certain types of cancer at a cost-effective price," said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. " Due to the proven biosimilarity in terms of efficacy and safety compared to the reference product Avastin ® , Vegzelma ® will be available in the future to treat some of the most commonly diagnosed cancers, affecting hundreds of thousands of patients in Europe every year."

The EC approval of Vegzelma ® by the European Commission follows the recommendation of the CHMP from June 2022.

Today's approval is based on the body of evidence, including the pivotal phase III study in patients with metastatic or recurrent non-small cell non-squamous cell lung cancer. The results were able to prove that first-line treatment with Vegzelma ® is very similar to the reference drug in terms of efficacy, safety and pharmacokinetics. 2

Vegzelma ® (CT-P16) is Celltrion's third oncology biosimilar to be approved in the EU, following approval of Truxima ® (rituximab biosimilar) and Herzuma ® (trastuzumab biosimilar). In addition, a Marketing Authorization Application for Vegzelma ® was submitted to the US Food and Drug Administration (FDA) in September 2021. Approval is expected in the third quarter of 2022.

About Celltrion Healthcare

Celltrion Healthcare is focused on providing innovative and affordable medicines to improve patient access to advanced therapies. The company's products are manufactured in state-of-the-art mammalian cell culture manufacturing facilities designed and built in accordance with US FDA cGMP guidelines and EU GMP standards. Celltrion Healthcare offers high-quality, cost-effective solutions through an extensive global network that spans more than 110 countries. Visit https://www.celltrionhealthcare.com for more information

About Vegzelma ® (CT-P16, bevacizumab biosimilar)

Vegzelma ® is a biosimilar to Avastin ® (bevacizumab). Bevacizumab Vegzelma ® is a recombinant humanized monoclonal antibody that binds to the growth factor VEGF (the main driver of vasculogenesis and angiogenesis). This inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1) and the kinase insert domain receptor (KDR) (VEGFR-2) on the surface of endothelial cells. The neutralization of the biological activity of VEGF regresses the vascularization of tumors, normalizes the remaining blood vessels supplying the tumor, inhibits the formation of new blood vessels supplying the tumor and thus prevents further tumor growth. 3 In the EU, Vegzelma ® indicated for the treatment of patients with metastatic colon cancer, non-small cell lung cancer, metastatic renal cell cancer, ovarian cancer, advanced cervical cancer and metastatic breast cancer.

Credits

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; 8.-13. April 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].

The source language in which the original text is published is the official and authorized version. Translations will be included for a better understanding. Only the language version that was originally published is legally valid. Therefore, compare translations with the original language version of the publication.

Contacts
Holly Barber
hbarber@hanovercomms.com
Tel.: +44 (0) 07759 301620

Donna Curran
dcurran@hanovercomms.com
Tel.: +44 (0) 7984 550312

 

Source:businesswire.com

Report Abuse