Hikma Discusses Quality Vs Quantity Approach At Jefferies

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.

The EMA’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam. Generics Bulletin discusses the new draft reflection paper and its significance for industry, reports on reactions from the event, and reveals the next steps unveiled by EMA officials.