US-based pharma giant Pfizer announced on 25 February 2022 that the US Food and Drug Administration (FDA) had accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab).
Abrilada (PF 06410293) was approved in the US as a biosimilar in November 2019 [1].
The patents on Humira expired in Europe in June 2017 [2]. However, in the US AbbVie has stated that although the composition of matter patent covering Humira expired in December 2016, non-composition of matter patents covering Humira expire no earlier than 2022. The company has therefore made settlement agreements with eight companies delaying the launch of biosimilars in the US until January 2023 [3, 4].
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.
If approved as interchangeable, Abrilada will be the second interchangeable adalimumab biosimilar and the third interchangeable biosimilar to gain FDA approval in the US. The landmark decision to approve an interchangeable insulin glargine biosimilar was made by FDA in July 2021 [5]. This was followed by the approval of Cyltezo (adalimumab-adbm) as interchangeable in October 2021 [6].
The application for interchangeability was supported by positive data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with Abrilada and its reference product, Humira, both of which were administered with methotrexate in adult patients with moderate to severe rheumatoid arthritis. The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines [7].
According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
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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 2022 Mar 18]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-adalimumab-biosimilar-Abrilada
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. AbbVie makes more deals delaying adalimumab biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 18] Available from: www.gabionline.net/Pharma-News/AbbVie-makes-more-deals-delaying-adalimumab-biosimilars-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Coherus sign licensing deal for Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 18] Available from: www.gabionline.net/Pharma-News/AbbVie-and-Coherus-sign-licensing-deal-for-Humira-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 18]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo as interchangeable [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 18]. Available from: www.gabionline.net/biosimilars/news/fda-approves-adalimumab-biosimilar-cyltezo-as-interchangeable
7. GaBI Online - Generics and Biosimilars Initiative. Positive results for Pfizer’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 18] Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Pfizer-s-adalimumab-biosimilar
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