Australia approves adalimumab biosimilar Abrilada

Biosimilares/Novedades | Posted 21/05/2021 post-comment0 Post your comment

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA), has approved the adalimumab biosimilar Abrilada (PF-06410293).

Adalimumab 2 V14A10

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].

Related article
Australia approves three biosimilars in first half of 2019

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To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

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Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

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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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Source: TGA

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