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FDA approves Mylan’s adalimumab biosimilar Hulio Posted 17/07/2020

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 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.

Related articles
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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