The Committee for Medicinal Products for Human Use adopted the guideline on ‘Similar Biological Medicinal Products Containing Monoclonal Antibodies’ at its meeting on 15–18 November 2010.

The guideline lays down the nonclinical and clinical requirements for biosimilar monoclonal antibody-containing medicines and was published on the agency’s website on 26 November 2010 for a 6-month public consultation period (up to 31 May 2011).

The guideline aims to reduce the regulatory hurdles for biosimilar manufacturers advocating a process based on relatively small comparability studies. The approval process will then be based on mechanistic studies and surrogate endpoints for efficacy rather than on hard endpoints, such as survival, which require large and expensive trials.

EMA has also released a related guideline on the immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use for consultation until the same date, and has already approved 13 biosimilars, including generic versions of human growth hormone, erythropoietin, and G-CSF and biosimilar medicines currently contribute savings of Euros 1.4 billion per year to European healthcare systems.

So far, EMA has received requests for scientific advice on only six biosimilar antibodies, and only expects two or three applications per year. This reflects the difficulties with making such biosimilars, despite the substantial economic opportunities due to patents on key brand products expiring.

Israeli generics giant Teva, is among the brave, however, and is already conducting clinical studies comparing its biosimilar version to Roche’s antibody drug Rituxan (rituximab), who’s patent expires in 2014. Rituxan had sales last year of US$6.2 billion (Euros 4.5 billion).

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