FDA grants interchangeable designation to adalimumab biosimilar Abrilada

Biosimilars/News | Posted 10/10/2023 post-comment0 Post your comment

US-based pharma giant Pfizer announced on 5 October 2023 that the US Food and Drug Administration (FDA) has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). The interchangeable designation applies to all approved indications of Abrilada, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. 

Adalimumab V13F21

The Abrilada biosimilar was first approved in the US in November 2019 [1]. In mid-2022, the FDA accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Abrilada as an interchangeable biosimilar to Humira [2]. Now, as an interchangeable biosimilar, Abrilada may be substituted at the pharmacy for the reference product without the intervention of the prescribing healthcare provider, depending on state pharmacy laws [3]. The interchangeability designation application was supported by positive data from the REFLECTIONS B538-12 study [4, 5].

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 [6]. It is used to treat all indications as stated above. It is hoped that, with the interchangeable designation, Abrilada will facilitate greater access to this treatment option. 

Abrilada will be available later in 2023 at two price points, aiming to achieve the broadest possible access for patients. Starting in late October 2023, it will be available at a list price (Wholesale Acquisition Cost) 5% below the Humira list price. Then, later in 2023, Abrilada will be available at a second list price 60% below the Humira list price.

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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 2023 Oct 10]. Available from:
www.gabionline.net/biosimilars/news/FDA-approves-adalimumab-biosimilar-Abrilada
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for interchangeability of adalimumab biosimilar Abrilada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 10]. Available from: www.gabionline.net/biosimilars/news/fda-accepts-application-for-interchangeability-of-adalimumab-biosimilar-abrilada
3. GaBI Online - Generics and Biosimilars Initiative. 45 US states have passed biosimilar substitution laws [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 10]. Available from: www.gabionline.net/policies-legislation/45-US-states-have-passed-biosimilar-substitution-laws
4. Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study. Prof Roy M Fleischmann, MD; Wassim Saikali, MD; Prof Sharad Lakhanpal, MD; Daniel F Alvarez, MD; Donna S Cox, PhD; Claudia Ana Ianos, MD; et al. DOI:https://doi.org/10.1016/S2665-9913(23)00161-3
5. GaBI Online - Generics and Biosimilars Initiative. Positive results for Pfizer’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 10]. Available from: www.gabionline.net/biosimilars/research/Positive-results-for-Pfizer-s-adalimumab-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 10]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab

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