Germany’s Merck KGaA (Merck Group) announced on 2 March 2016 that it had started a phase III clinical trial for its adalimumab biosimilar (MSB11022) in patients with chronic plaque psoriasis.
The global clinical trial will be carried out in 406 patients and is designed to compare the safety, efficacy and immunogenicity of MSB11022 versus blockbuster arthritis and psoriasis drug Humira in patients with moderate to severe chronic plaque type psoriasis.
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.
The AURIEL-Psoriasis (PsO) trial is a double-blind, randomized, active controlled, two-arm study. The primary objective of the study is to demonstrate equivalent efficacy between MSB11022 and Humira in terms of the number of subjects with Psoriasis Area and Severity Index 75% (PASI75) response at Week 16. Secondary objectives for the trial include comparative analysis of the per cent change from baseline in PASI75 response at Week 16, as well as comparative analysis of safety, immunogenicity and pharmacokinetics. The trial will be carried out across Europe, Asia, and North and Central America and is expected to be completed in September 2017.
The originator biological, AbbVie’s Humira (adalimumab), had worldwide sales of almost US$12.5 billion in 2014, making it a lucrative target for biosimilars. The patents on Humira expire in the US in December 2016 and in Europe in April 2018 [1].
‘Similar biologics’ of adalimumab have been launched by Zydus Cadilla (Exemptia) and Torrent Pharmaceuticals (Adfrar) in India in December 2014 and January 2016, respectively [2]. Amgen submitted its applications for approval of its adalimumab biosimilar (ABP 501) to the US Food and Drug Administration in November 2015 [3] and to the European Medicines Agency in December 2015 [4].
Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 18]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 18]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
3. GaBI Online - Generics and Biosimilars Initiative. Amgen submits biosimilar adalimumab application to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 18]. Available from: www.gabionline.net/Biosimilars/News/Amgen-submits-biosimilar-adalimumab-application-to-FDA
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar adalimumab application submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 18]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-adalimumab-application-submitted-to-EMA
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Source: ClinicalTrials.gov, Merck Group
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