In the first half of 2023, South-Korea based Celltrion Biologics announced the approval of their Yuflyma (adalimumab-aaty) biosimilar in the US, the winning of a bid to supply Italy and Belgium with bevacizumab biosimilar Vegzelma.
Yuflyma approval
In May 2023, Celltrion announced the US Food and Drug Administration (FDA) approval of biosimilar Yuflyma® (adalimumab-aaty), a high-concentration and citrate-free formulation of Humira (adalimumab) biosimilar.
Yuflyma was the first high-concentration and citrate-free adalimumab biosimilar to gain EU marketing authorization. FDA has now granted approval for the treatment of eight conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. Yuflyma will offer patients pre-filled syringe and autoinjector administration options to meet different preferences and needs. Yuflyma becomes the ninth adalimumab biosimilar approved in the US.
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 [1].
The originator product, AbbVie’s Humira (adalimumab), was approved by FDA in December 2002 and by the European Medicines Agency (EMA) in September 2003 [2].
Vegzelma news
Vegzelma, a biosimilar of bevacizumab, is approved in several jurisdictions, including Canada, the US, Japan and the EU [3-6].
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. The originator product, Avastin, is sold by Roche/Genentech [7].
Also in May 2023, Celltrion Healthcare has won bids to supply Vegzelma in Italy and Belgium to treat metastatic colorectal and breast cancer. Celltrion says that it will supply three Italian provinces (Lombardy, Emilia Romagna and Toscana), making up ~40% of the Italian market, for two to three years. It will also now supply two Belgian hospital groups (Brugge Regional Hospital Group and Onze-Lieve-Vrouw General Hospital) for two years.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 20]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab biosimilar Vegzelma approved and Aybintio launched in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 20]. Available from: www.gabionline.net/biosimilars/news/bevacizumab-biosimilar-vegzelma-approved-and-aybintio-launched-in-canada
4. GaBI Online - Generics and Biosimilars Initiative. New and upcoming biosimilars launches in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 20]. Available from: www.gabionline.net/reports/new-and-upcoming-biosimilars-launches-in-the-us
5. 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 Jun 20]. Available from: www.gabionline.net/biosimilars/news/bevacizumab-biosimilar-approvals-and-launch-in-japan-and-usa
6. GaBI Online - Generics and Biosimilars Initiative. EC approves bevacizumab biosimilar Vegzelma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 20]. Available from: www.gabionline.net/biosimilars/news/ec-approves-bevacizumab-biosimilar-vegzelma
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
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