The agreement between the two CROs, named ‘The Biosimilars Alliance’, aims to provide early assessment of the viability of candidate biosimilars before entering into costly clinical trials. These early assessment services will include in vitro and in vivo pharmacological assessments of activity and toxicological and immunotoxicological studies.

The alliance also aims to provide bioanalytical assay development to enable pharmacokinetic (PK) and pharmacodynamic (PD) assessments in animal and human studies, PK/PD modelling, immunogenicity screening during clinical studies and the regulatory and integrated project management support to ensure timely results for strategic decision-making.

The biosimilars business has been characterised by partnerships, which is not surprising considering that the costs of developing a typical biosimilar are estimated to be more than US$100 million and that they may take five to six years to develop–much more than a small molecule generic–reflecting the complexity of the molecules in question [1].

According to Celerion, the market for biosimilars is forecast to grow from US$2.4 billion in 2012 to US$44 billion by 2020, making it a lucrative market despite the costs.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Partnerships will drive biosimilar development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 9]. Available from: www.gabionline.net/Biosimilars/News/Partnerships-will-drive-biosimilar-development