Raymond A Huml
Quintiles, Inc., USA
Title: Evolution of the global biosimilars market: Lessons learned
Biography
Biography: Raymond A Huml
Abstract
Driving the burgeoning biosimilars industry is the lucrative biologics market, worth billions, with multiple patents expiring or set to expire soon. Historically, European and Canadian regulatory authorities have taken global leadership roles in biosimilars drug development. For example, EMA published test procedures and acceptance criteria for biological products in 1999. Europe leads the pack with the most advanced and detailed biosimilar regulatory guidance - spearheading a “totality of evidence” approach - and has granted the most approvals. Other countries are moving ahead rapidly to provide cheaper copies of biologics to their citizens. The US has made significant advances towards issuing draft guidance, though it still appears that near-term, approvals will be made on a case-by-case basis. Commensurate with limited guidance and extensive innovator lobbying, the FDA has granted only one biosimilars approval – a less complex protein (filgrastim-sndz or “Zarxio” from Novartis) - in March, 2015 under the 351(k) registration pathway approved under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. Further hampering progress towards US approval of a monoclonal antibody biosimilar, an FDA Advisory Committee meeting on a Remicade biosimilar from Celltrion was recently delayed. CDER recently announced that four additional biosimilar documents are set to be published in 2015. This presentation will describe the evolution of http://biosimilars-biologics.pharmaceuticalconferences.com/biosimilar development over the last 15 years, discussing key milestones leading to the first approvals in various markets. Outstanding issues will also be addressed relating to the race to identify and obtain the patients needed for global biosimilar registration trials.
