Adalimumab biosimilar meets primary endpoint in pharmacokinetic study

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Adalimumab biosimilar meets primary endpoint in pharmacokinetic study

Biosimilars/Research | Posted 12/02/2016 0 Post your comment

On 21 December 2015, Baxalta, a spinoff company from Baxter International, and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced positive results from a pharmacokinetic study with their candidate adalimumab biosimilar M923.

According to Baxalta’s press statement, M923 met the primary endpoint, which was to evaluate the pharmacokinetics of M923 compared to both US and EU sourced Humira (adalimumab) reference products.

The trial was a randomized, double-blind, three-arm, parallel group, single-dose study, which enrolled 324 healthy volunteers. In addition to ‘showing bioequivalence in pharmacokinetics’, the study also evaluated safety, tolerability and immunogenicity following single doses of M923 given by injection.

Dr Jim Roach, Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals said of the results that they ‘further validate our ability to develop high quality biosimilar candidates using our complex systems analysis platform’. He expects the results seen to date and ‘the data we generate from our ongoing pivotal trial in patients with chronic plaque psoriasis will continue to support the demonstration of biosimilarity of M923 to branded Humira’.

Baxalta and Momenta also announced the start of a phase III trial with M923 in patients with chronic plaque psoriasis in October 2015 [1]. The companies aim to have their first regulatory submission in 2017 and to launch the biosimilar as early as 2018.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Baxalta and Momenta start phase III trial for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 12]. Available from: www.gabionline.net/Biosimilars/News/Baxalta-and-Momenta-start-phase-III-trial-for-adalimumab-biosimilar

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Source: Baxalta