The European Medicines Agency has released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance for a six-month public consultation.
The document lays down the non-clinical and clinical requirements for marketing authorisation of a biosimilar claiming to be similar to a biological product already marketed.
This guideline updates the previous guidance, which came into effect in 2006. Since then, 14 biosimilar medicines have received marketing authorisation in the European Union and the number of scientific-advice requests received by theCommittee for Medicinal Products for Human Use (CHMP) on the development of biosimilar medicines has increased significantly.
On the basis of the experience gained since the release of the initial guideline, the revision provides additional guidance on the following topics:
- the risk-based approach for the design of non-clinical studies;
- the use of pharmacodynamic markers for the demonstration of clinical comparability;
- study design (non-inferiority versus equivalence), choice of an appropriate patient population and choice of surrogate endpoints in efficacy trials;
- the design of immunogenicity studies;
- extrapolation of efficacy and safety from one therapeutic indication to another.
This guideline is one of three overarching biosimilar guidelines, which are complemented by product-specific biosimilar guidelines. The other two overarching guidelines are:
- the guideline on similar biological medicinal products, which describes the concept of biosimilars and the general principles to be applied in demonstrating biosimilarity. A revision of this guideline was released for public consultation in May 2013;
- a guideline addressing the quality issues related to biosimilar development. Arevision of this guideline was released for a six-month public consultation in May 2012.