Biosimilars: The US Regulatory Framework.

  title={Biosimilars: The US Regulatory Framework.},
  author={Leah A Christl and Janet Woodcock and Steven de Kozlowski},
  journal={Annual review of medicine},
With the passage of the Biologics Price Competition and Innovation Act of 2009, the US Food and Drug Administration established an abbreviated pathway for developing and licensing biosimilar and interchangeable biological products. The regulatory framework and the technical requirements of the US biosimilars program involve a stepwise approach that relies heavily on analytical methods to demonstrate through a "totality of the evidence" that a proposed product is biosimilar to its reference… CONTINUE READING

From This Paper

Topics from this paper.


Publications referenced by this paper.
Showing 1-10 of 28 references

Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product

  • Christl ·Woodcock · Kozlowski
  • 2015
Highly Influential
5 Excerpts

Has IBD specialists ’ awareness of biosimilar monoclonal antibodies changed ? Results from a survey amongst ECCO members

  • R Anour
  • 2016

Biosimilars versus “biobetters”—a regulator’s perspective

  • R. Anour
  • Eur. Generics Biosimilars Initiat. J
  • 2014
1 Excerpt

Similar Papers

Loading similar papers…