Biologics

​PS1: Tailored development of biosimilars without efficacy and safety studies – Is this the future?

By 2025-11-18T09:58:00

Nils Jost

Key points: 

  • Regulatory thinking regarding biosimilars has evolved since the first biosimilars were approved in the EU in 2006 
  • Improved analytical technologies and understanding of modes of action and structure-function relationships, coupled with an excellent safety record, now enable the waiver of clinical efficacy studies

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