TORONTO, Jan. 19, 2023 /CNW Telbec/ - Celltrion Healthcare Canada Limited today announced that Health Canada granted a notice of compliance (NOC) on January 3, 2023 for Vegzelma^®, a biosimilar to Avastin^® (bevacizumab for injection).

The Health Canada authorization was based on a comprehensive data package of analytical, preclinical and clinical studies, demonstrating that Vegzelma^® is highly similar to the reference product Avastin^® in terms of efficacy, safety and pharmacokinetics.¹ 

Vegzelma^® is approved for the treatment of five types of cancer, including metastatic colorectal cancer (mCRC); locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC); platinum-sensitive recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer; platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer; and malignant glioma (WHO Grade IV) – glioblastoma.¹

"In cancer treatment, biologics play a key role and are principal components of many therapeutic regimens. However, the high cost of biologics is a burden on the healthcare system. Biosimilars enable access to more affordable medicines. The approval of Vegzelma^® in Canada provides oncologists with another safe and effective option of a bevacizumab biosimilar for patients and for the healthcare community", said Dr. Winson Y. Cheung, Professor at the Departments of Medicine and Oncology, University of Calgary.

"The approval of Vegzelma^® reinforces our commitment to increase accessibility and affordability to medicines," said Glen Choma, Commercial Director at Celltrion Healthcare Canada. "This represents a significant step in expanding access to cancer care. And, as a leading force in the global biopharmaceutical industry, it demonstrates our willingness to strengthen our presence in Canada and contribute to a more sustainable healthcare system for the future. As we continue to grow our biosimilar portfolio in Canada, innovative therapies like Remsima^™ SC, Yuflyma^®, and now Vegzelma^® are helping to make treatments more accessible to Canadians in need."

Celltrion Healthcare Canada is also proud to offer CELLTRION CONNECT^™, a patient-focused program tailored to support patients and healthcare providers. The program provides guidance with reimbursement navigation, financial assistance, injection and nurse support services, as well as pharmacy support services for patients throughout their treatment.

Vegzelma^® is Celltrion's first oncology biosimilar approved for use in Canada. Vegzelma^® was authorized in the EU in August 2022 and the UK, US, and Japan in September 2022. Regulatory reviews are ongoing in additional countries.

Notes to Editors:

About Vegzelma^®

Vegzelma^® is an anti-cancer monoclonal antibody treatment biosimilar to Avastin^® (bevacizumab). Vegzelma^® is a recombinant humanized monoclonal antibody which selectively binds to and neutralizes the biologic activity of human vascular endothelial growth factor (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. In Canada, Vegzelma^® is indicated for the treatment of patients with metastatic colorectal cancer (mCRC); locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC); platinum-sensitive recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer; platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer; and malignant glioma (WHO Grade IV) – glioblastoma.¹

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 Health Canada regulations, the U.S. FDA 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.ca

VEGZELMA is a registered trademark of Celltrion Inc.
AVASTIN is a registered trademark of Genentech Inc.

SOURCE:- Newswire