Momenta gains approval to start biosimilar adalimumab trial in Europe

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Momenta gains approval to start biosimilar adalimumab trial in Europe

Biosimilares/Novedades | Posted 12/12/2014 0 Post your comment

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 December 2014 the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a clinical trial application to initiate a clinical trial for its adalimumab biosimilar, M923.

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF). It is used to treat rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis. The originator product, AbbVie’s Humira (adalimumab), had 2013 worldwide sales of almost US$10.7 billion.

Momenta has developed the adalimumab biosimilar as part of a collaboration agreement with Baxter International (Baxter), with whom it signed a deal in December 2011 to collaborate on a total of six biosimilars. As part of this collaboration Baxter made an upfront cash payment to Momenta of US$33 million. The acceptance of this clinical trial in Europe triggers two milestones with an aggregate payment of US$12 million.

The companies expect to start the clinical study in the first quarter of 2015.

Biotech major Amgen and generics maker Sandoz appear to be the front runners in the race to biosimilar adalimumab, with both companies already carrying out phase III trials with their candidates [1].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab

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Source: Momenta