FDA issues draft guidance on statistical approaches to evaluating similarity for biosimilars

September 22, 2017 1:09 PM

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US FDA has issued an another guidance on statistical approaches to evaluating similarity for biosimilars this week.

The guidance is intended to provide advice on the evaluation of analytical similarity to sponsors interested in developing biosimilar products for licensure under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). This evaluation is to support the demonstration that a proposed biosimilar is highly similar to a reference product licensed under section 351(a) of the PHS Act. Specifically, this guidance describes the type of information a sponsor of a proposed biosimilar product should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan for the proposed biosimilar, and the statistical approaches recommended for evaluating analytical similarity.

This guidance is one in a series of guidance documents that FDA is developing or has developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). It serves as a companion document to the guidance for industry Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.

Since the passage of the BPCI Act in 2009, FDA has released a number of guidance documents on demonstrating biosimilarity, including the guidances for industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (final issued in 2015) and Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product (final issued in 2015). Based on the statutory definition of biosimilarity, these guidance documents are intended to assist sponsors in demonstrating biosimilarity for submitting a marketing application under section 351(k) of the PHS Act and to describe FDA’s current thinking on scientific principles to be considered in determining biosimilarity. Specifically, in the Scientific Considerations in Demonstrating Biosimilarity to a Reference Product guidance for industry, FDA described the totality-of-the-evidence approach that FDA would use in the review of biosimilar applications. The results of statistical analyses conducted to support a demonstration that a proposed product is “highly similar” to U.S.-licensed reference product are considered within the context of totality-of-the-evidence in determining if a proposed product is biosimilar to a reference product. The Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product guidance for industry describes the Agency’s recommendations to sponsors on the scientific and technical information, for the chemistry, manufacturing, and controls (CMC) section of a marketing application for a proposed product submitted under section 351(k) of the PHS Act.

The objective of this guidance is to assist sponsors in demonstrating, through an evaluation of the analytical similarity of the proposed biosimilar and reference product, that the proposed biosimilar and reference product are highly similar to support licensure under section 351(k) of the PHS Act. In general, an analytical similarity assessment involves a comparison of structural/physicochemical and functional attributes using multiple lots of the proposed biosimilar product and the reference product.

Comments on the draft can be made over the next two months.

Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry: Draft Guidance

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