FDA approves Mylan’s adalimumab biosimilar Hulio

Biosimilars/News | Posted 17/07/2020 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has approved Mylan/Fujifilm’s adalimumab biosimilar Hulio (adalimumab-fkjp) on 7 July 2020. The product is the sixth adalimumab biosimilar to be approved by FDA and is manufactured by Japan-based Fujifilm Kyowa Kirin Biologics.

Adalimumab V13F21

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.

Mylan’s Hulio is the sixth adalimumab biosimilar to be approved by FDA and overall the 28th biosimilar to be approved by FDA. The approval is based on a number of clinical studies in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Adalimumab was the first human monoclonal antibody to be approved by FDA and has been marketed as Humira by AbbVie since 2003. Although the patent on Humira expired in the US in 2016 and a number of biosimilars have since been approved by FDA [1-3], none are yet available on the US market.

Biosimilar versions of adalimumab will not be available in the US until 2023 due to patent disputes. AbbVie has made agreements with biosimilar developers to give them sequential launch dates, beginning with Amgen’s biosimilar Amjevita on 31 January 2023, see Table 1.

Table 1: FDA approved adalimumab biosimilars and their licence date
Manufacturer/ Company name Product name (Active substance) FDA authorization date Licence date
Amgen Amjevita (adalimumab-atto) 23 Sep 2016 31 Jan 2023
Samsung Bioepis Hadlima (adalimumab-bwwd) 23 Jul 2019 30 Jun 2023
Boehringer Ingelheim Cyltezo (adalimumab-adbm) 25 Aug 2017 1 Jul 2023
Mylan Hulio (adalimumab-fkjp) Jul 2020 31 Jul 2023
Fresenius Kabi To be advised To be advised 30 Sep 2023
Sandoz Hyrimoz (adalimumab-adaz) 30 Oct 2018 30 Sep 2023
Momenta To be advised To be advised 20 Nov 2023
Pfizer Abrilada (adalimumab-afzb) 15 Nov 2019 20 Nov 2023
Coherus To be advised To be advised 15 Dec 2023

Hulio is approved for a dosage of 20 mg/0.4 mL and for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. It is not indicated for the treatment of paediatric Crohn’s disease, hidradenitis suppurativa or uveitis however, which Humira is approved for.

Hulio currently has a launch date of 31 July 2023 in the US. In Europe, Hulio was approved back in September 2018 [4] and launched in several major European markets in October of the same year [5]. A recent study of adalimumab biosimilars in the Danish market revealed savings of over 80% [6], demonstrating the high cost saving potential of these biosimilars.

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Japanese approval for first adalimumab biosimilar

Mylan launches adalimumab biosimilar Hulio in Spain

Biosimilars of adalimumab

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Cyltezo
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Hadlima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Hadlima
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Abrilada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Abrilada
4. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-and-pegfilgrastim-biosimilars-Hulio-and-Udenyca
5. GaBI Online - Generics and Biosimilars Initiative. Mylan gains nod for Ogivri and launches Hulio in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/News/Mylan-gains-nod-for-Ogivri-and-launches-Hulio-in-Europe
6. GaBI Online - Generics and Biosimilars Initiative. Denmark achieves 83% reduction in adalimumab costs through switching [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/Research/Denmark-achieves-83-reduction-in-adalimumab-costs-through-switching

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Source: US FDA

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