Key to biosimilar competition will come from interchangeability, FDA officials say

With the growth in biologics spending, the biosimilar market is going to have to find new ways to keep up.

One avenue may open up with new interchangeable biosimilars that can be substituted without a doctor’s note, and which could help bring costs down for some pricier, patient-administered therapies. FDA officials discussed key flexibilities that they can make around the development of interchangeable biosimilars at an Association for Accessible Medicines’ industry conference yesterday in Bethesda, Md.

Jacqueline Corrigan-Curay

While the FDA has only signed off on three interchangeable biosimilars so far — Viatris’ insulin Semglee, Boehringer Ingelheim’s Humira interchangeable Cyltezo (launching next year), and Coherus’ Lucentis interchangeable Cimerli — Jacqueline Corrigan-Curay, CDER’s principal deputy center director, explained to the Association of Accessible Medicines’ industry conference yesterday that the agency is willing to work with industry where the science is justified.

She noted that in the case of Semglee, a clinical immunogenicity study comparing its insulin glargine product with Sanofi’s reference product Lantus was not considered necessary before earning the interchangeable tag. Likewise, Cimerli won approval as an interchangeable biosimilar without first running switching studies.

But as proof of how wonky the biosimilar reimbursement landscape can be, and how even an interchangeability designation doesn’t necessarily mean immediate uptake, Viatris had to launch multiple versions of Semglee, one with a modest discount and one that’s more expensive but with a higher rebate.

“What we’re going to really focus on in BsUFA III is how to develop an interchangeable product,” Corrigan-Curay, who’s also leading the search for a new director of FDA’s Office of Generic Drugs, explained.

Sarah Yim

Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, also offered attendees a deeper look into the BsUFA III updates and enhancements.

“The biggest change is we are now accommodating shorter timeline goals for labeling supplements. Specifically, for category A through C supplements. It isn’t that easy to do,” she said.

Those shorter timelines will expand to other supplements and BLA goals, but Yim noted that right now, they’re beginning with iterative changes.

“The biosimilar marketplace is at an inflection point, with good progress being made particularly with products administered in hospital and infusion setting,” Yim said, pointing to oncology. “It’s still early for patient self-administrated drugs, i.e. Medicare Part D drugs, but 2023 will be a big year for the market and we’re looking at that carefully.”

The first Humira biosimilars are set to launch in 2023, cutting into AbbVie’s mega-blockbuster sales, but it’s still been more than 5 years since some of this new competition first won FDA approval.

But Yim explained the extent to which FDA is looking help the industry and better align with global regulators on less onerous and more harmonized rules and regs, noting:

Because if we move to a comparator clinical trial that’s not needed but there’s a major regulatory agency that does say that’s needed, it sort of minimizes the benefit. Because y’all will still have to go out and do the comparative clinical trial for that one agency. So we’re taking a two-pronged approach for that. We held a workshop in September on increasing the efficiency of clinical trials when they aren’t needed and using innovative approaches, including statistical approaches to reduce sample size.”

And while drug pricing doesn’t fall under FDA’s purview, Yim also said FDA is now conducting regular meetings with CMS on implementing the Inflation Reduction Act. CMS negotiations over price don’t begin until 2026, but drugmakers are already beginning to point to the IRA as the reason behind dropped development programs.

fda
clinical trials