In January 2023, Alvotech-Bioventure, Sandoz and Samsung Bioepis announced advances for their adalimumab biosimilars in Saudi Arabia, Europe and Canada, respectively.
Adalimumab is a monoclonal antibody used to treat a range of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and inflammatory bowel disease (IBD) [1]. The reference product is AbbVie’s Humira.
The Alvotech adalimumab biosimilar, AVT02, has already received approval in many countries across the world as a high-concentration low-volume version of adalimumab, including Europe [2], Japan, Canada and Switzerland [3], under different partnerships and with brand names including Hukyndra, Libmyris and Simlandi. The Alvotech-Bioventure partnership now sees AVT02 approval by the Saudi Food and Drug Authority (SFDA) on 24 January 2023, where it will be marketed as Simlandi.
Sandoz announced on 30 January 2023 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), adopted a positive opinion for the marketing authorization of their citrate-free high concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab), the application was submitted on 17 June 2022 to EMA [4]. The authorization includes all indications covered by the reference medicine (Humira): rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and uveitis. Also, FDA has accepted Sandoz’s application for HCF of its adalimumab biosimilar Hyrimoz (GP2017) (adalimumab-adaz) on 21 July 2022 [5].
Samsung Bioepis announced on 3 January 2023 that Health Canada approved its HCF adalimumab biosimilar Hadlima (also known as SB5). Hadlima is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, adult Crohn’s disease, ulcerative colitis, adult and adolescent hidradenitis suppurativa, plaque psoriasis, adult and paediatric uveitis. Now, both high- and low-dose formulations of the product are available in Canada [6].
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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 Feb 17]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of two adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/news/ema-recommends-approval-of-two-adalimumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Advances for Alvotech’s partnerships in Japan, Canada and Switzerland [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/news/advances-for-alvotech-s-partnerships-in-japan-canada-and-switzerland
4. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for high concentration adalimumab biosimilar[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/news/ema-accepts-application-for-high-concentration-adalimumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for high concentration adalimumab biosimilar[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/news/fda-accepts-application-for-high-concentration-adalimumab-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis launches Hadlima in Australia and Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/news/Samsung-Bioepis-launches-Hadlima-in-Australia-and-Canada
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