FDA's Leah Christl Provides an Agency Perspective on the Biosimilars Landscape

Over time, the United States will see a dramatic increase in the number of biosimilar approvals based on the quantity of applications that the FDA is currently receiving, said Leah Christl, PhD, associate director for therapeutic biologics at the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, at the National Policy and Advocacy Summit on Biologics and Biosimilars held in Washington, DC, on April 17.

Christl kicked off the discussion by taking a look at where the biosimilar industry is 8 years after the implementation of the Biologics Price Competition and Innovation Act. She noted that the United States had preconceived notions of how biosimilar approval and uptake would proceed based on how the biosimilar approval process was going in Europe.

“We came in to having this approval pathway later than other areas of the world, and the expectation was that we would have companies bring to us the products that they had approved in other areas and would just seek approval here,” explained Christl. “But, we didn’t see that. What we saw was the global development programs were ongoing, and they were bringing monoclonal antibodies.”

Christl pointed to Europe, where the bulk of initial biosimilar approvals were for therapeutic protein products, such as filgrastim. While the United States’ first approved biosimilar was a filgrastim, the approvals that followed were for monoclonal antibodies, which Christl described as a “much more complex biologic space.”

However, currently, the United States is seeing the same applications that Europe is seeing, the US approval pathway is well established, and there exists a robust pipeline in regard to the applications being submitted for approval, said Christl.

Brian Kennedy, executive director for Alliance for Patient Access, pointed out that there is a natural hesitancy the United States concerning biosimilars, and Christl agreed, noting the need for both provider and patient outreach and the responsibility of the FDA to not merely approve safe and effective products, but also to explain the standards for approval and instill confidence in the pathway program.

The longevity the European Union’s biosimilar approval pathway also translates into different attitudes toward biosimilars in Europe, not just from a regulatory standpoint, but also from a prescribing and community standpoint, said Christl. There have been studies from government agencies on switching from a reference product to a biosimilar, patients are familiar with the data, and they’ve had more exposure.

“It’s not just enough to say, ‘trust us, we got this, it’s different, and you don’t need to understand why,’” said Christl. “It’s really important to explain what we’re doing, how we’re doing it, and what we’re looking for in our scientific standards. That then gives people the information to understand the underpinnings of the approval of those products and have confidence that they will be safe and effective products.”

Initially, the FDA focused its outreach on health providers, particularly prescribers, developing fact sheets to answer the common questions that they received and that prescribers may still seek clarification on. In turn, the agency hopes that the providers and organizations will take and modify the fact sheets for use in communicating with patients.

Christl ended the talk by offering an update on the FDA’s draft guidance on interchangeability: she explained that the agency has a commitment to issue either a revised draft or final guidance for demonstrating interchangeability no more than 2 years after the comment period closed. As the comment period closed in May 2017, the FDA has until May 2019, but understanding the importance of this guidance, the agency is trying to expedite the process.