Three years after first issuing draft guidance on biosimilars, the US Food and Drug Administration (FDA) has finally issued three final guidelines for biosimilar applications in the US. The guidances, however, fail to address the issue of interchangeability with reference biologicals, which the agency says it will address in another document.
FDA first published the three draft guidelines in February 2012 [1], following the signing into law of the biosimilars pathway as part of the Biologics Price Competition and Innovation Act (BPCI) in 2010.
The agency issued finalized guidelines on scientific and quality considerations, as well as questions and answers on biosimilars on 28 April 2015:
Scientific considerations in demonstrating biosimilarity to a reference product
Date: April 2015
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product
Date: April 2015
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
Biosimilars: Questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009
Date: April 2015
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444661.pdf
The guidance on scientific considerations is said by FDA to be the key guidance. It outlines what data the sponsor is expected to collect before meeting with FDA. It describes the stepwise and risk-based ‘totality-of-the-evidence’ approach FDA uses to evaluate the data and determines what trials are needed to demonstrate biosimilarity. These include analytical studies and at least one clinical pharmacokinetic study and, if appropriate, at least one pharmacodynamics study.
The second guidance outlines the quality considerations sponsors need to take into account when determining biosimilarity. Specifically, ‘sponsors should use appropriate analytical methodology that has adequate sensitivity and specificity to detect and characterize differences between the proposed product and the reference product.’
The question and answer guidance answers questions on biosimilars commonly asked by industry, and includes issues such as exclusivity, biosimilarity and interchangeability.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA finally issues draft biosimilar guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Guidelines/FDA-finally-issues-draft-biosimilar-guidance
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