FDA Issues Biosimilar Interchangeability Guidance

Last month, the FDA released its guidance for drugmakers attempting to gain approval for interchangeability between a biosimilar and reference product. 

The guidance recommends that in order for drugmakers to get a biosimilar approved as interchangeable, they must conduct one or more “switching studies,” demonstrating that patients can alternate between both products without decreases in efficacy or increases in adverse events. 

The guidance notes that interchangeability will be determined on an individual basis, depending on what type of product the biosimilar is and what type of condition it treats. 

According to the guidance: “The data and information to support a showing that the proposed interchangeable product can be expected to produce the same clinical result as the reference product in all of the reference product’s licensed conditions of use may vary depending on the nature of the proposed interchangeable product and may include, but need not be limited to, an evaluation of data and information generated to support a demonstration of a biological product’s biosimilarity.” 

The FDA also outlined a number of different types of data that can be presented when applying for interchangeability approval. The guidance notes that the FDA will consider all of these data together when making its decision.

“FDA intends to consider the totality of the evidence provided by a sponsor when the Agency evaluates the sponsor’s demonstration of interchangeability,” the guidance noted.

Additionally, the guidance states that for products that only require one administration, drugmakers may provide justification for not needing a switching study, in lieu of providing a switching study as evidence of interchangeability. —David Costill