As frustration mounts over the slower-than-expected uptake of biosimilars in the marketplace, two U.S. federal agencies vowed to take steps to ensure that companies seeking to sell these medicines have a chance to compete for U.S. patients.
In a joint statement, the Food and Drug Administration and the Federal Trade Commission cited several issues that are believed to have impeded wider use of biosimilars, which are lower-priced variants of brand-name biologics that are expected to deliver the same health outcomes.
For instance, the agencies promised to “address” any false or misleading statements that misrepresent the safety or effectiveness of biosimilars compared with biologics. Biosimilar makers have increasingly complained that some brand-name companies disseminate information suggesting the alternative medications may not be as effective.
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