Australia’s regulatory agency, the Therapeutic Goods Agency (TGA), has approved the adalimumab biosimilar Abrilada (PF-06410293).
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 adalimumab biosimilar was accepted for review by the TGA on 2 June 2020 and was approved on 22 February 2021. Abrilada is indicated for the treatment of ankylosing spondylitis, Crohn's disease, hidradenitis suppurativa, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis. Abrilada was also approved by the US Food and Drug Administration (FDA) in November 2019 [1]. While Pfizer’s adalimumab biosimilar (PF-06410293) was approved as Amsparity in Europe in February 2020 [2].
Abrilada is the third adalimumab biosimilar to be approved in Australia. Amgen’s Amgevita and Hadlima from Samsung Bioepis were approved by the TGA in October 2017 and January 2018, respectively [3]. The biosimilar is also the third from Pfizer to be approved in Australia. The company received approval for its trastuzumab biosimilar, Trazimera, and for its bevacizumab biosimilar, Zirabev, in 2019 [2].
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Abrilada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Abrilada
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia
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