Streamlining Biosimilar Approvals by Balancing Safety, Speed

Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center acknowledged the responsibility of the FDA regarding safety and efficacy in drug approvals in an interview with The Center for Biosimilars^®.

Abraham does not advocate for adopting the World Health Organization (WHO) guidelines entirely but sees promise in recent FDA movements on interchangeability since they propose the use of statistical modeling and shifting the clinical evidence burden to post-approval safety monitoring to expedite approval.

This transcript has been lightly edited for clarity.

What specific regulatory roadblocks are hindering the rapid approval of biosimilars, and how can we collaborate with regulatory bodies to streamline the process?

What we need to remember is that the FDA is the watchdog for everything that is related to drugs. It has an enormous responsibility and accountability, also to Congress, in terms of providing safe—in first instance—and then also effective drugs and that applies to biosimilars as well.

In a certain way, I expect the changes in terms of approval processes, and market entry, and post-approval monitoring will gradually, in an incremental way, stepwise, loosen up, for lack of a better word. So, biosimilar approval 2.0 will emerge at some point in time.

I'm not ready to be quoted saying that the FDA should adopt the WHO guidelines because the influence of the FDA and the European Medicines Agency (EMA) is global. Yes, we need to provide access to biosimilars in the rest of the world as well, but it needs to come from a very high level of standards related to quality and equivalence.

If you look, for instance, at issues—and that's an area where we see some movements within the FDA, and that has to do with interchangeability—there's a recent document that came out, and getting the interchangeability may, at some point in time, become a lot easier.

It can actually be done much easier because interchangeability can be modeled statistically. We have developed—while it's still in the prototype phase—a model that you could statistically create scenarios of interchangeability, take the data that are available, whether they're just pre-approval data, whether they're real-world clinical data, safety and effectiveness data, and model whether there is a risk and what that risk is of an adverse outcome related to interchangeable use of biosimilars.

It's also important then to shift the clinical evidence burden to safety post-approval. We can accelerate the process, for instance, as we do for some other drugs, and say, "Okay, we'll approve your biosimilar, but you are going to be watching yourself and reporting data to us based upon your biosimilars." In that process to develop—and I think that it is critical to develop channels for post-approval monitoring that go beyond voluntary reporting—make it required for the first 2 years on the market.

It doesn't mean that biosimilar companies would need to start sponsoring post-approval prospective studies or whatever because those are expensive. But you can do that to some extent with claims databases, electronic health records, to see what pops up in terms of safety signals as we use biosimilars.