Key Considerations for Biosimilar Product Development
Recent U.S. Food and Drug Administration (FDA) guidelines on biosimilars recommend taking a stepwise approach to minimize residual uncertainty and the evaluation of biosimilarity based on the totality of the data. The new guidelines provide a foundation for overall program design without addressing product-specific questions.
A stepwise approach
The stepwise approach starts with extensive physical, chemical and biological characterization of the proposed biosimilar, followed by comprehensive structural and functional comparability assessment of the biosimilar to the reference product. These initial assessments provide the foundation for the remaining development program. Biosimilars that are highly comparable to the reference product using a “fingerprint” comparison may require less extensive clinical data packages for approval.
Minimizing residual uncertainty
As companies search for ways to shorten the biosimilar development process, while ensuring they meet scientific and regulatory requirements, researchers should view the development process as a way to reduce residual uncertainty at each step as they conduct development programs. Companies should start this process in the analytical comparability phase of development and strive to meet with the FDA early in the process to discuss preclinical and clinical programs.
The right reference
The choice of reference product used in similarity assessments is another critical element to the development process. Current guidance from the European Medicine Agency (EMA) states that the reference product used for similarity assessments must be a product approved in the EMA’s jurisdiction. The FDA will assess data submitted in the marketing application in totality, allowing for data generated by either U.S. approved or non-U.S. approved reference products.
In summary, the FDA’s draft guidances provide the industry with significant insight into the agency’s expectations for conducting biosimilar development programs along with the data required for demonstrating similarity. It also outlines how the agency will review data during the development phase and marketing application review process.
The preceding article is drawn with permission from “Implications of Biosimilar Development,” from a recent issue of Applied Clinical Trials. Read the full article here.