One of the main thrusts of the recently passed BsUFA III legislation was to continue the evolution towards streamlining the clinical trial requirements for new biosimilar candidates. That process is seemingly moving forward with the request for funding opportunity proposals from the Food and Drug Administration (FDA) that “enhance biosimilar and interchangeable product development and regulatory science, specifically in the areas of (1) improving the efficiency of biosimilar product development and (2) advancing the development of interchangeable products.”
The funding opportunity announcement specifically suggests that the efficiency of biosimilar development can be improved through:
- Scientific advancements in analytical (including physical, chemical and biological function), and pharmacological assessments
- Improving the identification and risk assessment of relevant product, excipient, and container closure attributes
- Better defining acceptable product quality attribute differences
- Advancing analytical tools to detect relevant differences and use of statistical methodologies that are demonstrated to facilitate the comparative analytical assessment
- Scientifically appropriate methodologies to inform clinical trial design as it relates to biosimilarity
- Predicting comparative immunogenicity assessment using in silico and in vitro methodologies
- Developing broadly applicable approaches for the use of pharmacodynamic markers that support biosimilar product development
- Advances in statistical methods to streamline clinical trial design
To advance the development of interchangeable products, the FDA hopes to elicit “Developing alternative approaches than a switching study to meet the standard for interchangeable products administered more than once to a patient (e.g., real-world evidence such as health data from medical claims, electronic health records, data captured using digital tools, data from registries, and other sources, in vitro and in silico methods that predict immunogenicity risk associated with switching).”
The FDA is seeking to not only improve the capability and applications of its analytical characterization of biosimilar candidates but also to streamline the size of clinical studies required or alternatives to them. Any of these evolutionary improvements can significantly lower the cost of biosimilar development and likely shorten the time to FDA 351(k) submission (or supplemental submissions).
The due date for funding applications is April 26.
