John Gabrielson Explains Impact of Clinical Efficacy Tests, Government Policies on Biosimilar Development

Clinical efficacy testing may be more unreliable for assessing biosimilars than previously thought, and the FDA is looking into doing away with the requirement for approval, according to John Gabrielson, senior vice president at JSR Life Sciences and head of Similis Bio.

Transcript

Lately, there have been calls for the FDA to stop requiring clinical efficacy testing for the approval of biosimilars, and some FDA representatives have started softening to the idea of doing away with the requirement. What are some of the challenges that clinical efficacy tests pose to companies and what is Similis Bio’s perspective on this issue?

Gabrielson: I'll start by saying that I'm not an expert in clinical regulation or policy, but I did recently attend an FDA public workshop where this was directly addressed. Actually, it was a very interesting discussion. The FDA is actively looking at ways to reduce and even eliminate phase 3 clinical efficacy studies for biosimilars. If such a policy is eventually enacted, Similis will be very supportive of this because it pushes the burden of proof earlier into development, even to the preclinical stage, making the demonstration of analytical similarity even more important.

Compared to when biosimilars were first approved in the US. The sensitivity of our analytical methodologies have greatly improved, to the point now where we can detect differences between reference and biosimilar molecules that have no clinically meaningful impact.

So, this points to clinical trials being comparatively insensitive studies, leading to large trial requirements and extraordinarily high costs to bring biosimilars to market with really questionable value. Ultimately, we'll need well controlled manufacturing processes and information-rich methods to enable a future state without clinical efficacy requirements.

In September, President Biden signed an executive order for the increased investment in the development of biopharmaceutical and biotechnology industries. Why do you think more leaders are paying attention to this development space and what more needs to be done to ensure efficient development of biopharmaceutical products, including biosimilars?

Gabrielson: Our leaders are rightly paying attention to this space. I think there's ample opportunity to increase access to high-quality biologics and, at the same time, reduce patient costs. I don't think anyone is satisfied with the current state of our health care system in the US. Although only a very small part of that system, CMC [chemistry, manufacturing, and control] development of biosimilars does offer some intriguing opportunities, things like higher success rates through flexible program purchase rights, more efficient data usage through reusability of data, and better commercialization decisions through more choice in the marketplace. And Similis is directly involved in all of those opportunities.

What do you wish more stakeholders in the biosimilar sector knew about biosimilar development?

Gabrielson: I think we need to encourage creative disruption. Even after a decade of having an abbreviated pathway available for biosimilar development in the US, many people still apply traditional development paradigms to biosimilar development, and we really don't need to.

In some cases, the development of a biosimilar does mirror that of a novel biologic, but we often miss some big opportunities to accelerate biosimilar development because we're sort of stuck with a frame of reference that's too focused on traditional development approaches. There are opportunities to accelerate every aspect of biosimilar development—CMC, nonclinical, and clinical—and I've highlighted a few of those in my other responses. Similis is continuously striving to be part of the creative solutions that we need to make these products more accessible to patients.