The bevacizumab biosimilar Vegzelma produced by Celltrion received full label approval from Canada’s drug regulator, Health Canada (HC), on 3 January 2023. Back in November 2022, bevacizumab biosimilar Aybintio by Samsung Bioepis had been launched in Canada by Organon, offering a more affordable treatment for Canadian patients suffering from certain types of aggressive cancer.
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian [1].
Vegzelma (CT-P16) is an anticancer monoclonal antibody treatment biosimilar to Avastin. It is approved for the treatment of five types of cancer, including metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer and glioblastoma.
Vegzelma biosimilar is the sixth bevacizumab biosimilar approved 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. The first biosimilar to receive approval in Canada was Sandoz’s growth hormone treatment Omnitrope in 2009 [2].
The HC 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.
Vegzelma is the fourth bevacizumab biosimilar approved in the US in September 2022. At the same time the oncology biosimilar was also approved in Japan [3]. In August 2022, Vegzelma was authorized in the European Union [4]. Overall, Vegzelma is approved in 35 countries, including the Republic of Korea and the UK.
Hikma Pharmaceuticals has entered into a licencing agreement with Celltrion Healthcare to bring Vegzelma to market. Celltrion will handle the development, manufacturing and supply of Vegzelma while Hikma will be responsible for the marketinging and commercialization of the product in the Middle East and North Africa (MENA) region. This new agreement will help provide improved access to a crucial oncology treatment.
Vegzelma is the seventh biosimilar in HIkma’s portfolio via the long-standing partnership with Celltrion, the other six biosimilars are Celltrion’s Ruxima® (rituximab), Remsima® (intravenous infliximab), Herzuma® (trastuzumab), Remsima® SC (subcutaneous infliximab), YuflymaTM(adalimumab), and CT-P43 (ustekinumab).
On 7 November 2022, Organon Canada, announced the launch and availability of bevacizumab biosimilar Aybintio, a biosimilar of the reference biological Avastin, providing a new treatment option for adult Canadian patients affected also with metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and glioblastoma. Aybintio is developed and manufactured by Samsung Bioepis.
Since November 2021, Canada’s drug regulator, HC approved no less than five biosimilars for the treatment of diabetes, cancer, osteoporosis and autoimmune conditions. The drugs are biosimilars of Roche’s Avastin (bevacizumab), Johnson & Johnson and Merck’s Remicade (infliximab), Sanofi’s Lantus (insulin glargine), Eli Lilly’s Forteo/Forsteo (teriparatide) and Roche’s Herceptin (trastuzumab) [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of Bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 10]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 10]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-canada
3. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab biosimilar approvals and launch in Japan and USA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 10]. Available from: www.gabionline.net/biosimilars/news/bevacizumab-biosimilar-approvals-and-launch-in-japan-and-usa
4. GaBI Online - Generics and Biosimilars Initiative. EC approves bevacizumab biosimilar Vegzelma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 10]. Available from: www.gabionline.net/biosimilars/news/ec-approves-bevacizumab-biosimilar-vegzelma
5. GaBI Online - Generics and Biosimilars Initiative. Canada approves five biosimilars in last seven months [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 10]. Available from: www.gabionline.net/biosimilars/news/canada-approves-five-biosimilars-in-last-seven-months
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