FDA Issues Two Important New Biosimilar Guidances

January 17, 2017: “FDA released Draft Guidance for Industry: “Considerations in Demonstrating Interchangeability With a Reference Product.” The guidance provides an overview of important scientific considerations in demonstrating interchangeability and is intended to assist applicants in demonstrating that a proposed therapeutic protein product (e.g., monoclonal antibodies) is interchangeable with a reference product under section 351(k) of the PHS Act.

Among other things, this guidance contains information on:

  • Factors impacting the type and amount of data and information needed to support a demonstration of interchangeability;
  • The data and information needed to support a demonstration of interchangeability;
  • Considerations for the design and analysis of a switching study or studies to support a demonstration of interchangeability;
  • Recommendations regarding the use of U.S.-licensed reference products in a switching study or studies; and
    Considerations for developing presentations (e.g. container closure systems) for proposed interchangeable products.”

December 2016: Finalizes Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.

The new guidance replaces a draft guidance issued in May 2014. The new guidance “pertains to those products—such as therapeutic biological products—for which pharmacokinetic (PK) and pharmacodynamic (PD) data are needed to support a demonstration of biosimilarity. Specifically, the guidance discusses some of the overarching concepts related to clinical pharmacology testing for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials.” Click here to view the full guidance or if you are considering a biosimilar development program and would like to discuss contact PDG.



Made from living organisms, biologics are relatively large and complex molecules compared to conventional chemical drugs.  Biologics tend to be made up of proteins (and/or constituent amino acids), carbohydrates (e.g. sugars), nucleic acids (e.g. DNA), or combinations thereof, and also include cells or tissues used in transplantation. Because of their relatively complex chemical structure and method of manufacture, biosimilars (aka follow-on biologics) are never identical to the brand-name product, but will instead be shown to be highly similar.

In April 2006, the European Medicines Agency (EMA) approved Europe’s first ever biosimilar, Omnitrope®, a human growth hormone.  Since that time, the EMA has authorized a total of 20 biosimilars.  FDA also approved Omnitrope® in 2006, but it followed an April 2006 court ruling that the agency must review the application.  In doing so, FDA stated that the approval did not establish a pathway for approval of other follow-on biologics and that Congress would need to change the law in order for the agency to continue doing so.

On March 23, 2010, the President signed the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) into law, which amended the Public Health Service Act (PHS Act) and created an abbreviated review pathway for biosimilars.  The legislation required that sponsors submit a 351(k) Biologics License Application (BLA) that includes, inter alia, evidence that the compound is interchangeable with an already approved biological product.