Author Archives: Richard Johnson

The Evolving Manufacturing Landscape: Reflections from PDA President and CEO

The past 20 years have been a period of rapid change and development in the world and in the biopharmaceutical industry. One of the biggest changes has been the introduction of a pathway for biosimilars in the decade after 2010. Before that, no provision for “generic” versions of biologics existed. The European Medicines Agency (EMA) approved the first monoclonal antibody biosimilar in 2013, and the US Food and Drug Administration (FDA) followed with its first approval in 2015. Those approvals…