EMA revises guidance on biosimilar medicines
The Agency has given pharmaceutical companies six months to comment on the new advice
The European Medicines Agency has released revised guidance advising pharmaceutical manufacturers on the clinical and non-clinical issues that they should address when developing biosimilar medicines containing biotechnology-derived proteins as the active substance.
The EMA has given pharmaceutical companies six months to comment on the new advice, laying down guidelines on when the Agency should grant a marketing authorisation for a medicine when the manufacturer claims it is similar to a biological product already marketed. The guidance replaces 2006 advice, which has underpinned 14 biosimilar medicine marketing approvals. It includes new advice on:
- Using risk-based approaches when designing non-clinical studies;
- Employing pharmacodynamic markers for demonstrating clinical comparability;
- How to design studies regarding whether to use non-inferiority versus equivalence assessments, choosing appropriate patient populations for tests and identifying surrogate endpoints in efficacy trials;
- The design of immunogenicity studies; and
- Extrapolating efficacy and safety from one therapeutic indication to another.
EMA said the new guidance had been developed ‘on the basis of the experience gained since the release of the initial guideline’. The advice should be combined with two other existing sets of EMA advice on biosimilars. First, these describe the concept of biosimilars and general principles for demonstrating biosimilarity (a new version of this advice was released in May); and second, they offer guidance on quality issues related to biosimilar development, which was revised last year.
EMA said more advice was available from its officials and that companies developing biosimilars should contact regulators for more detailed information.
Consultation for the latest guidance ends on 31 October.
