The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.
The FDA and the Federal Trade Commission (FTC) said Monday they agreed to “enhanced collaboration” to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products without making false or misleading statements.
These issues will be discussed at an FDA public workshop on March 9, which will bring together stakeholders from industry, academia, and government agencies; such statements, the departments said, might be discouraging biosimilar uptake.
In addition, the FTC said it will review patent settlement agreements involving biosimilars to prevent antitrust violations.
The guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products, addresses questions developers may have when creating FDA-regulated promotional materials for reference products and biosimilars. FDA guidance documents do not set legally enforceable regulations but describe the agency’s current thinking on a topic. Comments on the draft guidance are being accepted today to April 6, and the FDA said that the measures announced this week are a deliverable of the Biologics Price Competition and Innovation Act, which created the pathway for biosimilar approval in the United States.
The guidance addresses how firms should identify reference and biosimilar products in promotional materials. According to the FDA, both types of biological products, originator products and biosimilars, may be identified by their proprietary name, nonproprietary or proper name, or core name, depending on the context. A proprietary name means the trademark or brand name, a proper name is the nonproprietary name designated by the FDA, and a core name is the component shared among the reference product and any related biological product, biosimilar product, or interchangeable product.
The guidance also addresses what kind what data from studies should be used in the advertising materials that are relevant for both. As an example, the FDA cited a situation where a biosimilar is licensed for fewer conditions than a reference product; in this case, the biosimilar's FDA-approved labeling would contain the information from the reference product’s approved labeling that is relevant to the approved conditions for the biosimilar.
What is likely to be deemed false or misleading question? According to the FDA, “Representations or suggestions that create an impression that there are clinically meaningful differences between the reference product and its biosimilar, such as promotional presentations representing or suggesting that a reference product is safer or more effective than its biosimilar product, or that a biosimilar is safer or more effective than its reference product, are likely to be false or misleading.” This also goes for impressions that a biosimilar is not highly similar to the originator, the document says.
The subject of the FTC’s involvement in the biosimilars market came up several times in 2019 in various congressional hearings about drug pricing as well as proposed legislation.
A role for the FTC was included in the Affordable Prescriptions for Patients Act of 2019 (S. 1416) but the bipartisan bill was blocked late last year by Senate Majority Leader Chuck Schumer, D-New York.
Another bipartisan bill introduced in the House of Representative, HR 2387, Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2019, codified the FDA’s plan to the decide if citizen petitions are abusive and meant to stall a generic drug’s approval, and it directs the HHS secretary to report such petitions to the FTC.