European Institute

Article Information

Category: Roundtables

Created on 10 May 2007

Georgette Lalis, Director for Consumer Goods, DG Enterprise and Industry, European Commission, outlined the European Union’s policy on the authorization of bio-similars and expressed her wish to continue and improve transatlantic dialogue on the subject. Dr. Murray Lumpkin, Deputy Commissioner for International and Special Programs, U.S. Food and Drug Administration presented the U.S. perspective was. The discussion was centered on the topic of regulatory frameworks for authorizing the marketing of follow-on biologics, referred to in Europe as bio-similars. The meeting was moderated by Charles Ludolph, Senior Vice President of Stonebridge International, LLC.