Doctors back unique biosimilar names
A host of physicians have fired off a letter to FDA Commissioner Margaret Hamburg (and CCing several Health and Human Services folks) urging the regulator to implement naming rules that create unique names for biosimilars so as to better differentiate branded biologics from their not-truly-identical biosimilar look alikes.
The name game is getting a lot of attention because although proponents argue unique names will make things less confusing when it comes to tracking adverse events, critics consider the proposed naming strategy as an attempt to undermine biosimilars. Critics are concerned that unique names will make it harder for healthcare providers and patients to view the branded biologic and the lookalike biosimilar as in-kind treatments. As a comparison, generics have common international proprietary names—the names that appear in parentheses, which means patients and physicians have not a just a brand name to consider when scanning the pain reliever aisle, but also common terms like acetaminophen or aspirin, which show overlap between the branded and generic iterations.
Although it could make adverse event tracking easier, critics say the lack of commonality amounts to denigration of the lookalike drugs. It could also help protect the branded biologic's turf. Several experts at a meeting convened by the Federal Trade Commission in February favored a one-drug, one-name system, saying it would not have an impact on patient safety.
The roster of doctors who signed the August 14 letter noted the adverse events reporting advantage of unique names as well as wrote that it would also prevent the assumption that a biologic and its biosimilar are approved for the very same uses.
One thing to note about these arguments is that a number of these unique-name arguments are signed off by doctors associated with industry-supported groups, including the Alliance for Patient Access which lists AbbVie, Astellas and Bristol Myers as associate members and the American Academy of Allergy Asthma & Immunology, which receives support from firms including Teva, Genentech and Merck.