The purpose of this guidance is to assist biosimilar sponsors pursuing approval through the 351(k) pathway in demonstrating adequate biosimilarity of a biologic product to its reference product.

Specifically the draft guidance describes: The draft guidance indicates that FDA will use a risk-based approach when assessing a sponsor’s data demonstrating biosimilarity, considering the totality of the data and information submitted. FDA suggests use of a “fingerprint-like” analysis algorithm that includes a large number of product attributes and their combinations with “orthogonal methods” in order to demonstrate similarity to a reference product.

• The role of clinical pharmacology studies in the demonstration of biosimilarity.
• Critical considerations in the use of clinical pharmacology studies to support biosimilarity.
• Developing clinical pharmacology data to support a demonstration of biosimilarity.
• Utility of simulation tools in study design and data analysis.

The draft guidance also discusses specific safety and immunogenicity recommendations for approval of biosimilar products – useful additions to find included in a guidance focusing on clinical pharmacology. FDA notes that data may need to be collected through additional studies at either pre- or post-approval phases.

This draft guidance is the first of five promised FDA guidances this year as they implement the Biologics Price Competition and Innovation Act of 2009 (BCPI Act), and releasing this draft guidance demonstrates FDA’s commitment to the biosimilar pathway. The lack of finalized biosimilar guidances does not preclude sponsors from filing biosimilar applications with FDA.

Sponsors of biosimilars are likely to take this guidance’s recommendations seriously as they develop their clinical study plans, and sponsors of originator biologics could also find FDA suggestions on study designs useful. FDA invites comments on the draft guidance. Comments are to be submitted to FDA either in written or electronic format by Aug. 12.

View the FDA’s draft guidance.