EMA adopts new guideline on clinical/non-clinical requirements

January 13, 2015 12:54 PM

EMA recently published the Guideline on biosimilars containing biotechnology-derived proteins as active substance: non-clinical and clinical issues which lays down the non-clinical and clinical requirements for a similar biological medicinal product (“biosimilar”).

The non-clinical section addresses the pharmaco-toxicological assessment. The clinical section addresses the requirements for pharmacokinetic, pharmacodynamic, and efficacy studies. The section on clinical safety and pharmacovigilance addresses clinical safety studies, including immunogenicity, as well as the risk management plan.

The current revision covers the following topics: a stepwise approach for the design of non-clinical studies; the use of pharmacodynamic markers; study design, choice of appropriate patient population and choice of surrogate and clinical endpoints in efficacy trials; clinical safety (including design of immunogenicity studies), risk management plan, and pharmacovigilance, and extrapolation of safety and efficacy. The guideline recommends a stepwise conduct of non-clinical and clinical studies.

The guideline which was published on EMA web page will come into effect on  July.

Source: EMA

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