Panelists Discuss Biosimilar Regulatory Standards Divergence

Panelists at the recent Festival of Biologics USA conference debated the worth of clinical efficacy studies for evaluating biosimilar equivalence. A Center for Biosimilars online post says that while many experts have said the clinical studies are not sensitive enough in comparison with other tests to provide convincing evidence of biosimilarity, regulators in the U.S. and UK have continued to assert the right to require such tests. Thus, they said, a recent UK decision not to require such tests is revolutionary.

“This is the way the future will look,” said Sandoz Regulatory Affairs Policy head Martin Schiestl. “We will see more complex biologicals, which can be developed as biosimilars, without the need for these very large efficacy studies, and the evidence to ensure the safety and effectiveness of biosimilars will be collected by other means” such as pharmacokinetic studies.

Other panelists said such regulatory changes can significantly improve the landscape for biosimilar development and acceptance, while too much divergence between national policies can hinder development as it adds complexity.

Amgen executive director of Global Biosimilars Regulatory Affairs and Regulatory and Research and Development Policy Leah Christl, who previously led the therapeutic biologics area at FDA, said that the agency tended not to provide micro-level, rigid guidance about biosimilar approval requirements because it makes sense to remain flexible so that it is possible to adapt to changing needs and situations.

“You can target the data you need to look at — are there clinically meaningful differences between the products — and look across the spectrum of different scientific studies, whether they are in the analytical space, looking at functional data or pharmacodynamic endpoints, versus those traditional clinical endpoints,” she said. “I expect that FDA is going to keep moving forward with that same type of approach.”