Regulatory Approval Pathways

In countries with robust regulatory standards, such as the US, the approval pathway for biosimilars is rigorous and scientifically appropriate. Approval of a biosimilar is based on the totality of evidence generated using a stepwise approach to demonstrate biosimilarity.1 This includes:

  • Comparative analytical characterization
  • Comparative nonclinical studies
  • Comparative clinical pharmacology testing
  • Additional comparative clinical studies

Additionally, pharmacovigilance is essential for all biologics, including biosimilars, to protect patients. Pharmacovigilance tracks adverse events and report/attribute them to the correct product and manufacturer. The ability to identify a biological medicine through systems that contribute to pharmacovigilance is a critical step in promoting patient safety.2


  1. USFDA. Scientific considerations in demonstrating biosimilarity to a reference product. 2015.
  2. Felix, et al. Nat Biotechnol. 2014;32:128-129.