On 17 April 2022, AbbVie announced that its Rinvoq (upadacitinib) had received European Commission (EC) approval. It is the first and only oral Janus Kinase (JAK) inhibitor approved to treat moderately to severely active Crohn's disease in adult patients. Rinvoq has the potential to rival AbbVie’s own blockbuster drug, Humira (adalimumab) and its biosimilars for inflammatory autoimmune conditions [1].
The EC approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study.
Rinvoq (upadacitinib) has been approved at 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses], for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological agent.
Upadacitinib is a selective and reversible Janus kinase (Jak) inhibitor. Upadacitinib works by blocking the action of enzymes called Janus kinases. These enzymes are involved in setting up processes that lead to inflammation, and blocking their effect brings inflammation in the joints under control.
‘The EC approval of Rinvoq in Crohn's disease is a significant milestone in offering patients the first and only once-daily oral treatment that can provide endoscopic improvement, and sustained symptom relief, making a difference in their daily lives,’ said Dr Thomas Hudson, MD, Senior Vice President, research and development, chief scientific officer, AbbVie. ‘With existing therapies, not all patients are able to achieve adequate disease control to meet their treatment goals, which is why we continue to embrace the challenge of expanding our IBD portfolio with new treatment options.’
Rinvoq has now been approved for the following indications: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis and ulcerative colitis. In contrast, Humira (and its approved biosimilars) is prescribed for ankylosing spondylitis, Crohn's disease, hidradenitis suppurativa, juvenile idiopathic arthritis, plaque psoriasis, psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis. Adalimumab is a tumour necrosis factor (TNF) inhibitor and binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases [2].
A number of biosimilars of Humira are due to launch in 2023, these include: Amjevita (Amgen), Cyltezo (Boehringer Ingelheim), Hadlima (Organon/Samsung Bioepis), Yusimry (Coherus), Hulio (Viatris/Biocon), Hyrimoz (Sandoz) and Abrilada (Pfizer) [1]. These launches come many years after the initial patents on Humira expired in the US (2016) [1] and Europe (2018) [3]. This is because, AbbVie has additional, non-composition of matter patents covering Humira that were not to expire prior to 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis delaying the launch of biosimilars in the US until January 2023 [4, 5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Humira (adalimumab) biosimilars pipeline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 27]. Available from: www.gabionline.net/reports/humira-adalimumab-biosimilars-pipeline
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 27]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
3. 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
4. GaBI Online - Generics and Biosimilars Initiative. The latest biosimilars agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 27]. Available from: www.gabionline.net/Biosimilars/News/The-latest-biosimilars-agreements
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
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