Baxalta and Momenta start phase III trial for adalimumab biosimilar

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Baxalta and Momenta start phase III trial for adalimumab biosimilar

Biosimilares/Novedades | Posted 16/10/2015 0 Post your comment

Baxalta – a spinoff company from Baxter International – and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 5 October 2015 that they had started a phase III clinical trial for their adalimumab biosimilar (M923) in patients with chronic plaque psoriasis.

The study will be carried out in 516 patients and will evaluate the efficacy, safety and immunogenicity of Baxalta and Momenta’s biosimilar adalimumab (M923) compared to AbbVie’s Humira (adalimumab) in patients with moderate to severe chronic plaque-type psoriasis.

The psoriasis trial is a multicentre, double-blind, randomized, active controlled, three-arm study. The primary objective of the study is to demonstrate equivalent efficacy between M923 and Humira in terms of improvement in the Psoriasis Area and Severity Index 75% (PASI75) response rate at Week 13. Secondary objectives for the trial include comparative analysis of safety, immunogenicity and tolerability. The interchangeability of M923 compared with Humira based on efficacy, safety and immunogenicity after repeated switching will also be compared to continuous use of Humira. The trial will be carried out across 68 different sites in Bosnia and Herzegovina, Bulgaria, Canada, Czech Republic, Estonia, Germany, Hungary, Latvia, Poland, Serbia, Slovakia, Turkey and the US in patients, aged 18–64 years and is expected to last one year seven months and 20 days.

MabThera/Rituxan had sales of US$12.5 billion in 2014, making it the best selling therapeutic on the market today. The patents on Humira expire in the US in December 2016 and in Europe in April 2018 [1]. Companies with biosimilars in the pipeline include Amgen, Fujifilm Kyowa Kirin Biologics and Sandoz (the generics division of Novartis) [2].

A ‘similar biologic’ of adalimumab (Exemptia) was launched by Zydus Cadilla in India in December 2014 [3].

Baxalta and Momenta are planning to have their first regulatory submission in 2017 and launch the biosimilar in 2018.

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.

Baxter and Momenta make biosimilars deal

References
1.   GaBI Online - Generics and Biosimilars Initiative. Biological patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 16].
2.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
3.   GaBI Online - Generics and Biosimilars Initiative. Adalimumab similar biologic launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 16]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-similar-biologic-launched-in-India

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Source: Baxalta, EU Clinical Trials Register,Momenta