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Positive phase III results for Sandoz etanercept biosimilar Posted 23/09/2016

Results of a study of Sandoz’s etanercept biosimilar (GP2015) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) have shown ‘equivalent efficacy’, according to the company.

Sandoz, the generics division of Novartis, announced on 4 July 2016 that the phase III EGALITY trial has met its primary endpoint ‘demonstrating equivalent efficacy of Sandoz biosimilar etanercept candidate to the originator product at week 12’.

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Rheumatoid arthritis and psoriasis are estimated to affect around 1.3 million and 7.5 million people, respectively, in the US.

The phase III EGALITY trial evaluated the efficacy, safety and immunogenicity of GP2015 compared to Enbrel in patients with moderate to severe chronic plaque-type psoriasis. The primary endpoint was the Psoriasis Area and Severity Index (PASI) 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment. Secondary endpoints included PASI 50, 75 and 90 response rates, time-based response on PASI score, as well as safety and immunogenicity.

The randomized, double-blind, multicentre, phase III study was started in June 2013 and planned to enrol 531 adults with moderate to severe chronic plaque-type psoriasis. It was carried out at 74 centres in Bulgaria, Czech Republic, Estonia, Germany, Hungary, Poland, Romania, Russia, Slovakia, South Africa, Ukraine and the UK and was expected to be completed in March 2015.

‘The EGALITY data, showing our biosimilar etanercept to be bioequivalent to the originator product, was part of the comprehensive data package submitted to the EMA [European Medicines Agency] and FDA [US Food and Drug Administration]’ according to Malte Peters, Head Global Clinical Development, Biopharmaceuticals, Sandoz.

EMA accepted Sandoz’s application for its proposed etanercept biosimilar (GP2015) on 8 December 2015 [1]. While FDA approved the company’s biosimilar Erelzi (etanercept) on 30 August 2016 [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 23]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar etanercept Erelzi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 23]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-etanercept-Erelzi

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Source: ClinicalTrials.gov, Sandoz

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