FDA's Scott Gottlieb, MD, Highlights Biosimilars Initiatives in J.P. Morgan Keynote Address

During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, FDA Commissioner Scott Gottlieb, MD, delivered a keynote address encompassing his goals for the direction of the FDA in the coming year.

A main component of Gottlieb’s goals for 2019 include doing his part to address the larger objectives of the Trump administration in bringing down drug prices. For his part, Gottlieb is “focused on bringing product competition. If we bring more products to the market, that will then promote price competition.”

In another effort to bring down drug prices, Gottlieb also remains focused on instilling confidence in the biosimilars market. “I’m optimistic about the trajectory of this market still. It’s been a slow ramp, but I personally always believed it would be slow.” he said. “If you look back at Hatch-Waxman, it took many years for that to become a robust market,” he said, referring to the establishment of the US generics marketplace.

Gottlieb recognized certain “commercial impediments” that could be responsible, in part, for the slow uptake seen in the market thus far. “The fact that there are rebates surrounding legacy products makes it hard to penetrate the market. It’s hard to penetrate and switch enough patients onto a biosimilar even if you discount the biosimilar heavily to offset the rebates on legacy products.”

However, though addressing rebates offered on products does not necessarily lie in the FDA’s purview, Gottlieb explained that he sees certain action items the FDA can take from a regulatory standpoint to help further biosimilar uptake. The FDA Commissioner laid out efforts that biosimilar developers and various other stakeholders can look forward to in the near future, such as finalized interchangeability guidance, the ability to carve out indications in drug applications, and an updated Purple Book, among other deliverables.

In addition to finalizing the long-awaited interchangeability guidance document, Gottlieb stated that the FDA is also looking to develop a structured application for drug manufacturers seeking interchangeability.

In terms of carving out indications, “We’re going to be putting out policy this year to explain how to carve back in indications. It’s fairly clear how indications can be carved out…what isn’t as clear is how you can seamlessly carve it back in without replicating clinical studies. We’re working on defining an efficient way to do that.”

Gottlieb went on to discuss the fact that the FDA is also currently looking at ways to allow biosimilar developers to source products from outside the United States for required biosimilarity studies included in the drug approval application. He explained that there are certain instances in which the US branded product and the ex-US branded product are “effectively the same and manufactured at the same facility, and that knowledge is known.” However, it then becomes a legal question whether this information is able to be shared due to Confidential Commercial Information agreements, though Gottlieb said that the agency is “looking into it.”

“In total, these policies will help facilitate market access for biosimilars. I see this as a market that’s going to be very viable in the future…biosimilars are becoming more physician-accepted, and we’re educating doctors around these products.”