Canada’s drug regulator, Health Canada, has approved the bevacizumab biosimilar Bambevi and the adalimumab biosimilar Abrilada (PF-06410293).
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.
Related article
Canada approves rituximab biosimilar Riabni
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.
Source: Apotex, Health Canada
0
Post your comment