FIFARMA’s take on transparency of regulatory approval of biosimilar products in Latin America

Published on: 15 November 2016


A must hear! If you are interested in biosimilar products and how these are approved in Latin America, take some minutes to listen to Thomas Shreitmuller’s take. Thomas Schreitmueller is the Global Lead for Regulatory Policy for Biologics – F. Hoffmann-La Roche. In this capacity he represents his company in various WHO, ICH, IFPMA, EFPIA, EBE, and BIO-biotech working groups. He is also a member of the Organizing Committee of the CMC Strategy Forum Europe. He gives here Fifarma’s position on “transparency” in regulatory decision making on the approval for biosimilar products.