The New Frontier for Improved Access to Medicines

What is the FDA’s Role?

In the United States, the FDA is the government agency responsible for reviewing and approving new medicines. Because of FDA’s experience with advanced medical products and its deep scientific expertise, under the BPCIA, the FDA is responsible for implementing the approval framework and for reviewing and approving applications for interchangeable biological products and biosimilar medicines. FDA approval is the gold standard for any medicine sold in the United States.

The FDA has taken significant steps to further develop the biosimilar approval process. The Agency has provided guidance documents on the steps that manufacturers should follow when seeking approval for their new medicines, such as securing meetings with the FDA team and demonstrating biosimilarity, so that biosimilars can be approved and sold in the U.S.

In March of 2015, the FDA approved the first biosimilar medicine, Zarxio® a Sandoz biosimilar for the reference brand Neupogen® approved for each of the five indications sought in its application. Subsequently, five additional biosimilars have been approved in the U.S., and five proposed biosimilars are under FDA review and more than 60 biosimilars are in the pipeline of the FDA’s Biosimilar Product Development Program.

As of late 2018, the following guidance documents and development plans have been released by FDA:

  • Guidance for Industry on Biosimilars: Q&As Regarding Implementation of the BPCI Act of 2009
  • Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
  • Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to Reference Protein Product
  • Guidance for Industry on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
  • Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under Section 351 (a) of the Public Health Service Act
  • Guidance for Industry on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
  • Draft Guidance for Industry on Labeling for Biosimilar Products
  • Draft Guidance for Industry on Considerations in Demonstrating Interchangeability with a Reference Product
  • Guidance for Industry on Nonproprietary Naming of Biological Products
  • Draft Guidance for Industry on Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
  • Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry 
  • Biosimilars Action Plan: Balancing Innovation &. Competition

Bringing Biosimilars to Patients in the U.S.