What’s in a name? A contentious debate over identifying biosimilars is sparking concern from antitrust regulators. These drugs are designed to emulate expensive biologics and are forecast to save billions of dollars in US health care costs. But finding the best approach for naming biosimilars has confounded regulators and divided the pharmaceutical industry amid clashes over patient safety and the potential for big profits.
At issue is whether biosimilars should be given the same name as biologics. Two months ago, the Food and Drug Administration issued draft guidelines that suggested both biologics and biosimilars can use the same name. But the agency also proposed that biosimilar names add a four-letter suffix that differs from the four-letter suffix that should follow a biologic brand name medicine. Essentially, the FDA appeared to be trying to appease as many people as possible, but that hasn’t worked.