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Positive phase III results for Sandoz’s adalimumab biosimilar Posted 02/06/2017

A phase III study of a proposed adalimumab biosimilar (GP2017) from Sandoz has met its primary endpoint ‘demonstrating equivalent efficacy’ to AbbVie’s Humira (adalimumab).

Sandoz, the generics division of Novartis, announced on 14 March 2017 that the phase III confirmatory efficacy, safety and immunogenicity study for its adalimumab biosimilar, GP2017, had met the primary endpoint of the study, i.e. proportion of patients who achieved a 75% improvement at Week 16, as measured by the Psoriasis Area and Severity Index (PASI 75).

The randomized, double-blind, multicentre, phase III trial evaluated the efficacy, safety and immunogenicity of biosimilar adalimumab (GP2017) Humira in patients with moderate to severe chronic plaque-type psoriasis. The trial, which planned to enrol 465 adults was started back in December 2013 and was planned to be completed in February 2016.

Data from the study, according to Sandoz, ‘confirmed equivalent efficacy by demonstrating PASI 75 response rates of 67% for GP2017 and 65% for Humira in patients with moderate to severe, chronic plaque psoriasis’. Results at Week 17 also ‘demonstrated similar safety and immunogenicity’ between GP2017 and Humira. Reported adverse events (AEs) and anti-drug antibodies were also similar across both treatment groups and observed AEs were in line with Humira’s known safety profile.

Sandoz is playing catch up when it comes to adalimumab biosimilars. Amgen’s adalimumab biosimilar Amjevita/Amgevita/Solymbic (ABP 501) was approved by the US Food and Drug Administration (FDA) in September 2016 [1] and by the European Medicines Agency (EMA) in January 2017 [2]. Boehringer Ingelheim submitted applications for marketing approval for its adalimumab biosimilar (BI 695501) to EMA and FDA in January 2017 [3].

Editor’s comment
It should be noted that data of the study presented in this article was published as a press release. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 2]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Amgevita and Solymbic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 2]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Amgevita-and-Solymbic
3. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 2]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-submits-biosimilar-adalimumab-application-to-both-EMA-and-FDA 

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Source: ClinicalTrials.gov, Sandoz

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