US-based pharma giant Pfizer announced on 18 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (PF 06410293).
Abrilada (adalimumab-afzb) is a proposed biosimilar to AbbVie’s Humira (adalimumab), which had worldwide sales of US$18.4 billion in 2017. The patents on Humira expired in the US in November 2017 and in Europe in June 2017 [1]. 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 Amgen and Samsung Bioepis delaying the launch of biosimilars until January 2023 [2, 3].
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.
Abrilada has been approved for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.
The FDA approval was based on the review of a comprehensive data package, which, according to Pfizer, demonstrated the biosimilarity of Abrilada to the reference product. It included results from the REFLECTIONS B538-02 clinical comparative study, which evaluated the efficacy, safety and immunogenicity of Abrilada and found no clinically meaningful differences in efficacy, safety or immunogenicity compared to the reference product, each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis [4].
Abrilada has been approved as a biosimilar, not as an interchangeable product. 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.
The approval of Abrilada marks the sixth biosimilar from Pfizer (and its subsidiary Hospira) to be approved by FDA. Inflectra (infliximab-dyyb) was approved in the US in April 2016 [5], Ixifi (infliximab-qbtx) was approved in December 2017 [6], Nivestym (filgrastim-aafi) in July 2018 [7], Retacrit (epoetin alfa-epbx) in May 2018 [8] and Trazimera (trastuzumab-qyyp) in March 2019 [9].
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Biosimilars of adalimumab
References
1. 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
2. GaBI Online - Generics and Biosimilars Initiative. Amgen’s adalimumab biosimilar will only be launched in US in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22] Available from: www.gabionline.net/Biosimilars/News/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023
3. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22] Available from: www.gabionline.net/Biosimilars/General/AbbVie-and-Samsung-Bioepis-reach-patent-deal-over-Humira-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Positive results for Pfizer’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22] Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Pfizer-s-adalimumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves infliximab biosimilar Inflectra [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-infliximab-biosimilar-Inflectra
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar infliximab Ixifi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-infliximab-Ixifi
7. GaBI Online - Generics and Biosimilars Initiative. FDA approves filgrastim biosimilar Nivestym [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-filgrastim-biosimilar-Nivestym
8. GaBI Online - Generics and Biosimilars Initiative. FDA approves epoetin alfa biosimilar Retacrit [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-epoetin-alfa-biosimilar-Retacrit
9. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Trazimera [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Trazimera
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