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Results: 1-7 of 7

State momentum to restrict use of biosimilars slows
  • Shook Hardy & Bacon LLP
  • USA
  • February 21 2013

Legislation in Mississippi that would have allowed pharmacists to substitute biosimilars only if they are deemed interchangeable with the prescribed


States consider bills to allow biosimilar substitution for brand-name biologics
  • Shook Hardy & Bacon LLP
  • USA
  • January 24 2013

In the absence of U.S. Food and Drug Administration (FDA) rules providing a pathway of approval for biosimilar drugs, legislators in several states


Pharmacists focus on biosimilar substitutions in FDA draft guidance comments
  • Shook Hardy & Bacon LLP
  • USA
  • June 7 2012

Pharmacy trade groups have urged the Food and Drug Administration (FDA) to allow pharmacists to substitute biosimilar drugs for their biologic counterparts without physician approval if the agency has already determined that they are interchangeable


FDA considers expanding the definition of OTC drugs
  • Shook Hardy & Bacon LLP
  • USA
  • March 29 2012

Seeking input from consumers, pharmacists, health care providers, regulators, and insurers, the Food and Drug Administration is considering expanding the definition of nonprescription drugs


FDA personnel comment on U.S. biosimilars program in NEJM perspective article
  • Shook Hardy & Bacon LLP
  • USA
  • August 18 2011

Food and Drug Administration (FDA) officials have published an article in the New England Journal of Medicine (NEJM) that discusses some of the issues facing the agency in establishing a regulatory framework under the Biologics Price Competition and Innovation Act of 2009 for the approval of biologic drugs that are “biosimilar” to already-approved products



Chris A. Johnson
  • Shook Hardy & Bacon LLP