The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use adopted a positive opinion on 26 April 2023 recommending Novartis' Cosentyx (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults.
The potential approval of Cosentyx to treat HS is an extension of the indications for which it is already approved and makes the drug the first treatment option to treat HS in nearly a decade.
Secukinumab is a human IgG1κ monoclonal antibody that binds to and inhibits the protein interleukin (IL)-17A, an important cytokine involved in inflammation. In Europe, secukinumab is prescribed for the following indications: adult and paediatric plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA), ankylosing spondylitis (AS, radiographic axial spondyloarthritis), non-radiographic axial spondyloarthritis (nr-axSpA), juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA), juvenile psoriatic arthritis (JPsA), and HS. In the US, it is approved for indications mirroring the above [1].
The recommendation of Cosentyx to treat HS was based on data from two late-stage trials that enrolled approximately over 1,000 patients from 40 countries, with over 55% of patients experiencing an HS clinical response measure by Week 52 and about 50% of Cosentyx-treated patients achieving a relevant reduction in pain due to HS during the same period.
In late 2022, China’s Bio-Thera Solutions announced that dosing has begun in a phase III clinical study for BAT2306, a biosimilar of Cosentyx (secukinumab). The study is a randomized, double-blind, parallel group, active control study to compare the efficacy and safety of their copy biological product with Cosentyx in patients with moderate to severe plaque psoriasis [1]. Luye Pharma Group is also developing a secukinumab copy biological in China.
Other biological drugs used in treatment of HS include adalimumab, a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. The reference product of this is Humira but a number of biosimilars have been approved [2].
The patents for Cosentyx expired in the US on 8 October 2020; in Europe, Cosentyx was first approved and launched in May 2015 [3]. Currently, there is no biosimilars secukinumab approved globally.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Advances for Bio-Thera’s secukinumab and mepolizumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 19]. Available from: www.gabionline.net/biosimilars/news/advances-for-bio-thera-s-secukinumab-and-mepolizumab-copy-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 19]. 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
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