Canada approves adalimumab and bevacizumab biosimilars

Biosimilars/News | Posted 22/10/2021 post-comment0 Post your comment

Canada’s drug regulator, Health Canada, has approved the bevacizumab biosimilar Bambevi and the adalimumab biosimilar Abrilada (PF-06410293).

Health Canada V13I20

Bambevi is a biosimilar of Roche’s Avastin (bevacizumab). 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.

Apobiologix, a division of Apotex, announced on 27 September 2021 that Bambevi had been approved by Health Canada to be used in combination with chemotherapy to treat specific types of colorectal, lung, brain and ovarian cancer.

Abrilada is a biosimilar of AbbVie’s Humira (adalimumab). Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, and ulcerative colitis.

Pfizer’s Abrilada was approved on 29 June 2021 as a solution for subcutaneous injection at a dose of 20 mg/0.4 mL. It has been approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, psoriasis and uveitis.

These approvals mean that Apotex now has four biosimilars approved in Canada and Pfizer has five [1].

Editor’s comment
Readers interested to learn more about Health Canada’s view on the clinical development of biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

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LATIN AMERICAN FORUM

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

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LATIN AMERICAN FORUM

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de esta semana: Grupos de gastroenterólogos argentinos emiten su posicionamiento sobre el uso de biosimilares

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 22]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-canada

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Source: Apotex, Health Canada

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