The European Medicines Agency (EMA) has released a revised draft guideline to address the clinical and non-clinical issues relating to biosimilars. The draft guidance is split into two sections: a non-clinical section which addresses pharmaco-toxicological assessment, and a clinical section that addresses the requirements for pharmacokinetic, pharmacodynamic, and efficacy studies.
The draft updates previous guidance from 2006. Since then, the market has developed rapidly and the number of applications being considered by the EMA's Committee for Medicinal Products for Human Use (CHMP) has increased. 14 biosimilars have received market approval since the previous guidance, and on the basis of the experience gained through the process, the current revision provides additional guidance these 5 topics:
A risk-based approach for the design of non-clinical studies
The use of pharmacodynamic markers
Study design, choice of appropriate patient population and choice of surrogate endpoints in efficacy trials
Design of immunogenicity studies
Extrapolation of indication
The EMA is seeking comment on the proposed guidelines over the next 6 months. What do you think? Why not join our discussion on LinkedIn, or leave a comment below. Want more from Total BioPharma? Sign up to our newsletter – it doesn't cost anything and only takes a minute.
If you're interested in hearing more about strategy and innovation in biosimilars, you might be interested in attending the World Biosimilar Congress Europe 2013, 12-13 November 2013.