In the FDA’s Biosimilar Action Plan, the agency indicated that it seeks to partner more closely with the Federal Trade Commission (FTC) to help remove barriers to competition that are not directly within the FDA’s control. However, in recent comments to HHS, the FTC has called on the FDA to use its own authority to foster biosimilar competition.
In the FDA’s Biosimilar Action Plan, the agency indicated that it seeks to partner more closely with the Federal Trade Commission (FTC) to help remove barriers to competition that are not directly within the FDA’s control. However, in recent comments to HHS, the FTC is calling on the FDA to use its own authority to foster biosimilar competition.
In the comments, the FTC agrees with the FDA that Risk Evaluation and Mitigation Strategy (REMS) programs may be subject to abuse and can block biosimilar competition. The commission says that it supports the FDA’s efforts to clarify circumstances under which it will waive single, shared REMS requirements, and adds that legislation could help to provide a solution to the ongoing problem.
However, the FTC also highlighted the fact that the FDA has existing authority that could help promote the market for biosimilars, and it called on the agency to leverage its own ability to foster competition. The FDA should “consider certain steps to improve biosimilar and interchangeable competition,” it says, starting with finalization of guidance on interchangeability.
“Experience with generic drugs teaches that automatic substitution is crucial for successful generic drug entry, market acceptance, and consumer savings,” writes the commission, and adds that a lack of guidance is hindering both market acceptance and cost savings.
Next, the FTC is urging the FDA to allow biosimilar developers to forego costly, time-consuming bridging studies and instead allow for a global comparator biologic, as has been called for by industry and some in the scientific community.
Read more about biosimilar bridging study requirements.
The commission also took issue with the FDA’s broadly unpopular naming conventions for biosimilars, which require a product’s name to include a 4-letter suffix, devoid of meaning, to differentiate products.
“The 2015 FTC staff comment suggested that the FDA’s naming convention, which departed from FDA tradition, could cause physicians to believe mistakenly that the products have clinically meaningful differences,” the comments note. “Such confusion arising from the naming convention may dissuade physicians from prescribing the biosimilar and consequently diminish competition in biologic drug markets.” The FTC asks the FDA to “reconsider” its final guidance, saying that reliance on brand names would address pharmacovigilance concerns and help prevent unintended switching.
Finally, the commission praises the FDA’s efforts to make its Purple Book more useful, and proposed making data in the book searchable. Furthermore, If the FDA continues to use its nomenclature system, emphasizing the root name of biologics in the Purple Book—and separating the suffix into a different column—would help to reduce any physician confusion about products, it says.