Gottlieb: FDA Working on a Dozen New Biosimilar Policies
FDA commissioner Scott Gottlieb says the agency is working on about a dozen new policies to help the fledgling biosimilar market grow and gain acceptance. “We are going to be advancing new policies to try to stimulate more biosimilar development,” Gottlieb said during a 3/28 keynote address at CNBC’s Healthy Returns conference in New York. “We are taking a hard look at how we determine interchangeability so that we can make determinations that biosimilars can be used interchangeably with the branded drugs.”
Gottlieb told the conference that the new policies are needed to stimulate the biosimilar space and to ensure product developers don’t shy away from opportunities due to increasing hurdles and risks. He reminded the audience that in the early days of the Hatch-Waxman act and traditional generic drug approvals there was a lot of reluctance to use the products initially. “I think we will see a lot of biosimilar competition come onto the market, and I think we will see more consumer and provider acceptance of biosimilars,” Gottlieb predicted.
One policy will compel brand biologic manufacturers to tighten lot-to-lot variability to make it easier for proposed biosimilars to demonstrate sameness or similarity. “When we use our new analytical tools to look at currently marketed biologics, we see a lot of variance in lot-to-lot manufacturing and a lot of variance in the products over time where there is drift in the formulation of these products,” Gottlieb said. The variability could eventually have a “clinical consequence,” he said, adding that the drift also makes it hard to copy those products because the proposed biosimilar will have to be studied in more patients to show similarity. Once the variability is tightened, it is going to be “easier to copy those drugs,” he said.
Opining on the new policies under development, Gottlieb said each should “incrementally move the ball in the direction to create more avenues for biosimilar competition. I think the biggest impediment is market access and the ability for the biosimilars to actually get on the market.” He said impediments such as how branded biologics are reimbursed and “these sort of stacked royalties sitting on top of the branded drugs make it difficult for biosimilars to penetrate the market even at a lower price because they can’t move enough market share in order to offset the benefits that the branded companies are paying to the supply chain through kickbacks or rebates. So, I think the provider community is going to need to make a decision whether or not they are willing to move away from some of those structures in order to create this market,” he said. “If we don’t see soon the ability of the biosimilars to build market share when they come to market, I am worried it will discourage biosimilar prospects from making the investment.”