Dr Scott Gottlieb Describes Biosimilar Challenges and Opportunities, FDA Releases New Guidance

Scott Gottlieb, MD, Commissioner of the FDA, has signaled that while biosimilars are on the rise, they need a boost from stakeholders if development of these therapies will continue to grow. Speaking to health and medical reporter Laurie MicGinely at The Washington Post’s Chasing Cancer Summit, Gottlieb said that the FDA is currently reviewing 10 applications for biosimilars, and that 27 biosimilar developers have asked for guidance concerning their applications.

While those numbers are comparatively low, Gottlieb sees the potential for greater movement in the biosimilars industry soon. “We’re going to see a real pickup in the rate of biosimilar development. I think we’re at the early stages of biosimilar, similar to where we were 30-years ago with generic drugs,” he said.

As it did with generics, the uptake of biosimilars will depend on overcoming provider and patient resistance to switching treatments: “There is reluctance on the part of providers to switch over…especially if you’re thinking about curative therapy. And so, we’re going to have to continue to educate providers. We’re spending some money on the part of FDA to go out and do some public education campaigns to educate providers about the robustness of the process that biosimilars go through, but I think it’s going to be slow adoption.”

Payers have an opportunity to play a key role in both spurring biosimilar adoption and also encouraging further biosimilar development, said Gottlieb. “If [biosimilar developers] don’t think that they can capture [20%] or 30% market share within the first [5] years of being on the market or whatever the economic model is, they might say, ‘You know what? This is a category we’re going to stay away from.’ So, I think the payers have an opportunity to perhaps think about guaranteeing some market share, and then putting the obligation on themselves for having to drive adoption.” Insurers could help to spur uptake and secure the future of biosimilar therapies by “guaranteeing perhaps a market share to some of the biosimilars that are coming onto the market.”

Meanwhile, under Gottlieb’s leadership, the FDA itself has been working to better facilitate the entry of biosimilars in the marketplace; this week, the agency released new biosimilar draft guidance titled “Statistical Approaches to Evaluate Analytical Similarity.” The guidance, a companion document to the existing “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product,” focuses on providing biosimilar developers with advice on demonstrating similarity between their proposed biosimilars and their reference drugs.

The guidance recommends that a minimum of 10 product lots representative of the variability of the reference product be sampled, and that 10 biosimilar lots be included in analytical similarity assessments. Developers should also account for all reference product lots available to them, even if the lots were not used in the final similarity assessment, and should provide data to support comparability of any materials manufactured with different processes or scales. Developers should determine a plan for addressing changes in attributes over the shelf-life of a reference product, and should pre-specify which results from multiple tests will be selected for analytical similarity data.

The FDA reiterated that the reference product should be US-licensed, and that if a developer sought to use data derived from products approved outside of the United States, it should consult with the FDA first. Combining data from a US-licensed product and a product licensed in another territory would “not be expected to support a determination that the proposed biosimilars is highly similar to the US-licensed reference product.”

The guidance also calls for a 4-stage analytical similarity assessment plan (development of risk-ranking attributes, determination of statistical methods to be used, development of a statistical analysis plan, and finalization of the analytical similarity plan) and describes formal methods of testing statistical equivalence.

The FDA will receive comments on the draft guidance until November 21, 2017.