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Canada Approves Celltrion Bevacizumab Biosimilar


Health Canada has granted approval for Celltrion Healthcare’s bevacizumab biosimilar (Vegzelma) referencing Avastin for the treatment of multiple forms of cancer.

Health Canada has granted approval for Celltrion Healthcare’s bevacizumab biosimilar, Vegzelma, for the treatment of multiple forms of cancer, according to a report from KoreaBioMed.

The biosimilar represents the fifth bevacizumab biosimilar and fiftieth biosimilar approval in Canada. The other bevacizumab biosimilars include Abevmy, Aybintio, Bambevi, Mvasi, and Zirabev. It is also the second Canadian approval in 2023, following the approval of Samsung Bioepis and Organon’s high-concentration, citrate-free formulation of Hadlima, an adalimumab biosimilar referencing Humira.

Vegzelma, also known as CT-P16, referencing Genentech’s Avastin. Bevacizumab products are inhibitors for vascular endothelial growth factor receptors. The drug is used in the treatment of metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and glioblastoma. Vegzelma was approved for all the same indications as the reference product.

The news comes after the FDA approved Vegzelma as the United States’ fourth bevacizumab biosimilar in September 2022. In August 2022, the European Commission gave its decision granting Vegzelma marketing authorization throughout the European Union. Overall, Vegzelma is approved in 35 countries, including the Republic of Kora, the United Kingdom, and Japan.

“We hope that Vegzelma, the third anti-cancer antibody biosimilar after Truxima and Herzuma, will settle quickly in the Canadian market…. We will do our best to supply high-quality biopharmaceuticals at reasonable prices to provide various treatment options to patients at home and abroad,” a Celltrion representative said.

In January 2023, Celltrion signed an agreement with Hikma Pharmaceuticals for the commercialization of Vagzelma in 17 countries throughout the Middle East and North African region., including Jordan and Morocco, according to the Korea Herald. It would be the sixth drug developed by Celltrion to be distributed by Hikma in the region, a list which includes Truxima (rituximab biosimilar), Remsima (infliximab biosimilar), and Herzuma (trastuzumab biosimilar).

Prior to the approval, Celltrion announced the submission of a biologics license application for the American approval of its infliximab biobetter, Remsima SC. The biobetter references the company’s infliximab biosimilar (Remsima), which references Remicade, and is the only infliximab product in the world that allows for subcutaneous administration.

Additionally, KoreaBioMed reported that in early January 2023, Celltrion signed an development deal with Rani Therapeutics over an oral formulation of the former’s ustekinumab (CT-P43) biosimilar for the treatment of psoriasis, plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. The development would leverage Rani Therapeutics’ RaniPill GO capsule, which could allow for the oral administration of any drug, including large molecules.

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