FDA raises concerns on ‘anti-competitive’ biosimilar practices
Although uptake of biosimilars in the US market was expected to cut the price of originator biologics, resulting in large amounts of savings, these expectations were not reached, with the US healthcare system potentially failing to save up to $7.2bn (€6.5bn) annually.
Forecasts regarding the expected level of uptake in 2020 are not quite harmonized; however, in an announcement released previously, the US Food and Drug Administration (FDA) cited increased communication to patients as a precondition to increased adoption.
Nevertheless, information quality that would enhance this market seems to be threatened, triggering a response by the regulatory body. Last week saw the agency release a joint statement with the Federal Trade Commission, declaring it intends to strengthen its policy against practices that threaten competition in the biologics market.
Specifically, the FDA condemned companies that make “false or misleading statements that compare biological reference products and biosimilars,” which can potentially create negative misperceptions about the safety or effectiveness of approved biosimilars.
On the commission's side, FTC chairman, Joseph Simons, stated that “Practices [...] are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation,” highlighting the need to enforce the antitrust laws in healthcare markets.
Actions taken by the regulators
As a result of observing the above practices, the FDA said it will collaborate with the FTC on future ‘public outreach’ efforts, including bringing together participants from industry, academia and government agencies to discuss issues relating to competition.
Moreover, the two organizations announced their plans to exchange information about best practices to prevent activities that impede access to samples of the reference product that the prospective biosimilar applicant needs for testing.
Additionally, the FTC will be reviewing patent settlement agreements involving biosimilars, as part of an effort to prevent antitrust violations.
Finally, the actions to protect market competition also saw the FDA release draft guidance, outlining its suggestions on presenting data and information “in a truthful and non-misleading way” about biosimilars and reference products in FDA-regulated promotional materials.
