Is FDA Streamlining Regulations in the Biosimilar Space?

Pharmaceutical Executive: Is FDA streamlining regulations in the biosimilar space?
Gillian Woollett: FDA’s approach to streamlining has been in the works for a while. We’re seeing it portrayed as if we’re seeing something sudden happening, but this has been gained through the experience either of 30 years of comparability or 20 years of biosimilars.

FDA is ultimately aiming to be science-based and consistent. The experience with biosimilars has been good, they’ve done exactly what they were expected to do.

There seemed to be a goal of being more efficient while also dealing with the biosimilars void. A recent report says that abut 90% of biologics facing a loss of exclusivity in 10 years have no biosimilars at all in development.

Unlike the generics-space, you expect a generic for every drug when exclusivity expires, we only have that for 10% of biologics and that’s a very serious concern globally.

PE: How will recent regulatory developments at FDA impact feasibility assessments in clinical planning?
Woollett: It’s important, but by the time guidance comes out, it often reflects a lot of discussions. The agency already had the authority to waive the comparative effectiveness studies.

The issue with the new guidance is the predictability. How much can sponsors know when they start looking at developing a biosimilar if they will or won’t need to do that comparative effectiveness study.

This is FDA learning from industry and vice versa. FDA has learned that sponsors aren’t doing the step-wise development and waiting for analytical results before planning a clinical study. That created a conundrum because even if the analytics were extremely good, a financial commitment had already been made.

That’s where the biggest realization has been for the opportunity to know from the beginning that the analytics, functional studies, and PK are good, you won’t need clinical comparative efficacy study, that changes the paradigm.

PE: How are global regulatory agencies adjusting their policies for biosimilars?
Woollett: The clear leaders in the space of biosimilar development have been the European agency, the UK, and US FDA. There’s leadership across the most conspicuous markets and they’ve been working together forever. There’s a shared innovative history.

Also, there’s the question of access, which has raised issues globally by other regulators (some more sophisticated than others) as to what is actually needed to have a biosimilar available.

For some of those markets, it’s a bit tenuous. For major markets, they want to be consistent regulatorily, but they also want to promote biosimilar development. It’s generally recognized that they’ve been conservative with biosimilar development for the first decade or so.