EMA: Guideline on similar biological medicinal products containing interferon beta

This guideline lays down the non-clinical and clinical requirements for interferon beta (IFN-β) containing medicinal products claiming to be similar to another interferon beta already marketed. The non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects.