One week after releasing its 11-part biosimilar action plan, the US Food and Drug Administration (FDA) announced it will hold a public hearing to gather input on how it can facilitate the development of biosimilars and ensure they enter the market in a timely fashion.
At the hearing, set to take place on 4 September 2018 at FDA's White Oak headquarters, FDA will solicit input from stakeholders on nine questions on the scientific and legal challenges to bringing biosimilars to market and how to reduce barriers to competition once they are on the market.
While FDA has approved a total of 12 biosimilars since the creation of an abbreviated pathway for such products under section 351(k) of the Public Health Service Act, only a fraction of them have seen commercial launches.
Despite the promise of biosimilars to provide lower cost competition to some of the top selling biologics on the market, legal challenges and hesitancy from insurers and healthcare providers have led biosimilars to make a relatively minor splash on the US market compared to Europe, where biosimilars have been available longer.
Some of the questions related to competition FDA hopes to gather input on include what the agency can do to help biosimilars and interchangeable products enter the market more quickly after approval, how the agency can promote confidence in biosimilars among patients and healthcare practitioners and whether "umbrella exclusivity" could be used to shield certain biologics from biosimilar competition.
The agency is also asking a blanket question addressing any other challenges that "have the potential to disrupt the balance between innovation and competition" for biologics and biosimilars, and what can be done to address those challenges.
On the scientific front, FDA is seeking insights on how it can facilitate biosimilar development programs that use non-US licensed biologics as comparators and whether the agency could lower the number of lots needed for analytical characterization of proposed biosimilars and their reference products without compromising its standards for approval.
However, David Rosen, a partner at Foley & Lardner and co-chair of the firm's life sciences industry team, told Focus that the legal issues delaying the launch of biosimilars are outside FDA's purview. "That's in the hands of the courts and the companies that are involved," he said.
Rosen also said that the savings offered by biosimilars might not be great enough to convince hospitals and formularies to switch and that the companies marketing the reference versions of these products are aggressively working to maintain their market share.
Instead, Rosen said FDA have a greater impact on competition by facilitating the development of more biosimilars, which in turn could lead to lower prices for products with multiple biosimilar competitors.
Federal Register Notice