Drugs

Biosimilar Interchangeability Guidance Outlined

An online National Law Journal post says that a January FDA draft guidance on considerations in demonstrating interchangeability with a reference product outlines the nature and quality of the evidence biosimilar applicants should expect the agency to demand before making a finding of interchangeability for a biosimilar. “Because of the practical impossibility in creating ‘bioequivalent’ biopharmaceuticals,” the post says, “the determination of ‘biosimilarity’ under the Biologics Price Competition and Innovation Act (BPCIA) requires a showing of both high structural similarity and high functional similarity.

While biosimilarity is the minimum showing required for FDA approval, according to the article, it will not result in regulatory exclusivity under the BPCIA, which is limited to the first interchangeable biosimilar. Interchangeability, which is not the same as bioequivalence, requires a showing that the biosimilar “can be expected to produce the same clinical result as the reference product in any given patient” and that “for a [biosimilar] that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the [biosimilar] and the reference product is not greater than the risk of using the reference product without such alteration or switch.”

The post says the guidance included these key points:

the more complex the product, the more comparative and functional characterization will be necessary to support a demonstration of interchangeability;
if a biosimilar is intended to be administered to an individual more than once, FDA expects the sponsor to conduct a “switching study” or studies to show that there is no diminished risk in terms of safety or efficacy in alternating or switching between the biosimilar and the reference product;
biosimilars using reference products with known immunogenicity issues will require more data to support interchangeability than those not using such reference products; and
post-marketing data without corresponding data derived from an appropriately designed, prospective, controlled switching study or studies generally is not sufficient to show interchangeability.

The guidance also sets forth protocols for integrated study designs for sponsors interested in showing biosimilarity along with interchangeability, and it describes the delivery device and labeling comparison between the biosimilar and the reference product.

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