Fresh Insights Into the Practicalities of Developing Biosimilar Biologics

Biotech products coming off patent afford a window of opportunity to obtain a marketing approval for a “follow-on biologic” by a new product developer. If the supporting data are sufficient to authorize interchangeability and
substitution, the new product is defined as a similar biologic or “biosimilar.” Europe is leading the way in defining the regulatory pathway for biosimilars.  This article shares lessons learned that can provide strategic insights to guide biosimilar development plans. Read More: 2009 10 Focus Dowlat