FDA is stressing the abbreviated part of the biosimilar development pathway, assuring sponsors that they can limit their required clinical demonstration with early analytical work. Rather than clinical evidence, characterization data will play a more significant role since (according to the agency) the purpose of a biosimilar development program is to establish a product’s similarity to the reference product, not safety and efficacy
The nascent pathway has “created cognitive dissonance in industry,” said Janet Woodcock. “People are going to have trouble with this.”
This represents, according to the Pink Sheet, “a tonal shift” for officials, who for most of the pathway’s young life emphasized the complexity of biosimilar products and how clinical studies were expected to be a key part of applications.
Woodcock said sponsors can limit their required clinical programs by bringing extensive characterization data early in the development process.
“The amount of clinical evidence needed, we conceive, is related to the amount of residual uncertainty that remains after you’ve done those less costly, actually more quantitative, and less time-consuming analytical and functional studies.”
According to Kathleen Uhl, deputy director in CDER’s Office of Medical Policy, “The product development for a biosimilar is not a one-size-fits-all. Agency scientists will evaluate the applicant’s integration of [these] various type[s] of data and information to then provide an overall assessment that the biological product is biosimilar to a reference product.”
“What’s most important to illustrate here is the foundational elements of the analytics,” Uhl said. “The more extensive the analytical and functional comparative characterization, then it’s likely to permit a selective and targeted approach to subsequent non-clinical and clinical studies in order to determine biosimilarity.”
Predictability, as with biosimilarity, is in the eyes of the beholder.