Biosimilars Get Bespoke Service: EMA To Pilot Tailored Scientific Advice
Executive Summary
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.
You may also be interested in...
Blockbuster Competitors Figure Large Among Biosimilars Under Review in EU
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.
Biosimilars Will Get PDUFA-Style Reviews Under New User Fee Plan
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.
EU Group Facilitates Switching Multinational Trials To CTR
Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”