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Regulatory Focus™ > News Articles > Fresh Insights Into the Practicalities of Developing Biosimilar Biologics

Fresh Insights Into the Practicalities of Developing Biosimilar Biologics

Posted 01 October 2009

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.

 

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