Biosimilars Get Bespoke Service: EMA To Pilot Tailored Scientific Advice
Quality data will be focus of ‘extra advice’ offered by European Medicines Agency’s pilot, which will suggest directions for sponsors’ next steps but stop short of formal data evaluation.
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Amgen’s first biosimilar – a competitor to AbbVie’s Humira – and three would-be competitors to Amgen’s own Neulasta are among the 17 biosimilar products that are under evaluation at the European Medicines Agency.
FDA will have a total of 12 months to review 351(k) applications and additional time to schedule certain product development meetings under the Biosimilar User Fee Act II agreement; measures to enhance management of user fee resources and improve hiring will carry over from PDUFA VI.
Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”