FDA publishes revised Biosimilarity recommendations, offering pathway to more efficient biosimilar approvals
Author:
Erik Doevendans
Chief Technical Officer & Principal Consultant
Key Details
FDA’s draft guidance streamlines biosimilar approval by reducing the need for comparative efficacy studies (CES). The guidance provides revised criteria outlining the circumstances in which conducting CES may be unnecessary for a Biologics License Application submitted through the 351(k) biosimilar and interchangeable biosimilar pathway. Since the introduction of this pathway just over fifteen years ago, the progress of biosimilar development has often been hindered by regulatory requirements that can be overly stringent or redundant. CES in particular has placed significant developmental, financial, and logistical burdens on biosimilar programs.
With the updated framework, the Agency highlights that contemporary orthogonal analytical technologies provide sensitive instruments for high resolution characterization of therapeutic proteins thereby acknowledging that the sensitivity of analytics in detecting differences is superior to that of a clinical trial.
What this means for sponsors:
Under this streamlined approach, when the comparative analytical assessment (CAA) proves that the candidate biosimilar closely resembles its reference product, a CES may not be required, provided three conditions are met:
The reference product and proposed biosimilar product are manufactured from clonal cell lines, are highly purified, and can be well-characterized applying physicochemical and in vitro biological methods;
The relationship between quality attributes and clinical efficacy is generally understood for the reference product, and these attributes can be evaluated by assays included in the CAA; and
A human pharmacokinetic similarity study is feasible and clinically relevant.
How Scendea can support:
At Scendea, we have a team of leading biosimilar experts, with extensive experience supporting a broad range of biosimilar development programs across multiple therapeutic areas.
We offer comprehensive support throughout the development pathway, including assessing the suitability of the CAA, preparing robust immunogenicity risk assessments, and designing scientifically sound comparative pharmacokinetic studies. Our deep regulatory and scientific expertise ensures that your development strategy is fully aligned with current expectations and positioned for efficient, successful progression.
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