Gottlieb: FDA Working on "A Dozen Policies" on Biosimilars

In an interview today with CNBC’s Meg Tirrell at the Healthy Returns conference, FDA Commissioner Scott Gottlieb, MD said that early estimates of savings that could be garnered through biosimilars in the United States “probably weren’t realistic.” That said, “I think we will see a lot of biosimilar competition come on to the market. And I also think we're going to see more consumer and provider acceptance of using biosimilars.”

Gottlieb explained that the FDA is working on “advancing new policies to try to stimulate more biosimilar development. We're taking a hard look at how we determine interchangeability so that we can make determinations that biosimilars can be used interchangeably with the brand of drugs.”

Notably, Gottlieb said that, in looking at currently marketed biologics, “We see a lot of variants in lot-to-lot manufacturing of existing biologics and also a lot of variance in the products over time where there's drift in the sort of formulation of the biologics that are currently on the market. And those don't seem to have clinical consequence. But they could have clinical consequence.”

Product drift also makes biosimilar development more challenging, because “you have sort of a moving target on the market and you want to come in and create a biosimilar to copy it, you have to study your biosimilar against more drugs, more patients, because there's more variability in the currently marketed brand of drugs.”

Gottlieb indicated that the agency would be putting forward policies that would compel branded drug makers to “tighten up their manufacturing, to have less variance of their biologics that are currently on the market.” In theory, this change could make it easier to develop a biosimilar using smaller studies, he said.

When asked whether these policies will stimulate greater development of biosimilars, Gottlieb said that biosimilars would be “slow build,” but that the FDA is working on about “a dozen policies” concerning biosimilars. Yet there remain impediments to biosimilars, “whether it's distributive PBM or the health plan with these kickbacks, these rebates.” Providers, he said, will have to decide whether they will help to create a robust market, “Because if we don't see soon the ability of the biosimilars when they come to market to actually build market share, I'm worried that when manufacturers look at this market, they're going to say: ‘Look, this is too hard.’ We can't get more than 10 percent market share, so we're not going to make the investment.”

These comments come just weeks after Gottlieb addressed America’s Health Insurance Plans at its National Health Policy Conference, saying that “The economics of development are currently unstable; and the pipeline of biosimilar products that we hope for could be dramatically affected by the weakening of market incentives to bring these products to patients.”