Korea-based biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 24 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (SB5).
Hadlima (adalimumab-bwwd) 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.
Samsung Bioepis submitted its application for approval of Hadlima to FDA in September 2018 [4]. Hadlima has been approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis
The FDA approval was based on data derived from a randomized, double-blind 52-week phase III study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomized to receive either Hadlima or the adalimumab reference product (Humira). At Week 24, the ACR20* response rate was 72.4% in the Hadlima group versus 72.2% in the Humira group. The safety profile of Hadlima was comparable to Humira up to Week 24. At Week 24, 254 patients receiving Humira were re-randomized in a 1:1 ratio to continue on Humira or transition to Hadlima, and 254 patients receiving Hadlima continued to receive Hadlima. Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.
Hadlima 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 Hadlima marks the fourth biosimilar from Samsung Bioepis to be approved by FDA. Renflexis (infliximab-abda) was approved in the US in April 2017 [5], Ontruzant (trastuzumab-dttb) was approved in January 2019 [6] and Eticovo (etanercept-ykro) was approved in April 2019 [7].
Samsung Bioepis has also received approval for its adalimumab biosimilar (SB5) as Imraldi by the European Medicines Agency in June 2016 [8]. Hadlima was also approved by Korea’s Ministry of Food and Drug Safety in September 2017 [9].
*American College of Rheumatology 20% response criteria
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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
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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 Aug 16] Available from: www.gabionline.net/Biosimilars/General/AbbVie-and-Samsung-Bioepis-reach-patent-deal-over-Humira-biosimilar
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8. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilar Imraldi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 16]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilar-Imraldi
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