Phase III results of adalimumab biosimilar demonstrate equivalence

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Phase III results of adalimumab biosimilar demonstrate equivalence

Biosimilars/Research | Posted 04/09/2015 0 Post your comment

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 6 July 2015 phase III data demonstrating the ‘clinical equivalence’ of their adalimumab biosimilar (SB5) compared to the originator biological, Humira.

The randomized, double-blind, parallel group, multicentre clinical study evaluated the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy.

The study, which was carried out in Lithuania and Poland, planned to enrol 490 patients and the primary endpoint was the American College of Rheumatology 20% response criteria (ACR20), at week 24. Secondary endpoints included ACR20 at week 52, ACR50 and disease activity score based on a 28 joint count (DAS28).

Samsung Bioepis reported that at week 24, the ACR20 improvement from baseline was within the pre-specified equivalence margin for SB5 compared to Humira, leading the company to conclude that the biosimilar is ‘clinically equivalent’ to Humira.

The originator product, AbbVie’s Humira (adalimumab), is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis. Humira was approved by the US Food and Drug Administration in December 2002 and by the European Medicines Agency in September 2003 [1]. Humira had worldwide sales of almost US$12.5 billion in 2014 [2].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab

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Source: ClinicalTrials.com