On August 27, 2015, FDA published its first draft guidance for the industry on “Nonproprietary Naming of Biological Products.” Biological products, or “biologics,” are medical products that generally come from living organisms (e.g., humans, animals, yeast, bacteria) and are ordinarily used to prevent, diagnose, or treat diseases. Examples of biologics include vaccines, blood transfusion products and gene therapies. A “biosimilar” is a biologic that gains FDA-approval based on a showing that it is “highly similar” to another already-FDA-approved biologic (a “reference product”) and there are no clinically meaningful differences between the two products in terms of safety and effectiveness.
Biologics can be expensive. Biosimilars undergo an abbreviated, less-costly licensure process and therefore may create significant cost-savings for consumers. Unlike generic versions of drugs, a biosimilar is not an exact duplicate of its reference product; rather, it is only a close replica.
FDA’s draft guidance states that each previously licensed and newly licensed biosimilar must bear a unique four-letter suffix in addition to the nonproprietary name it will share with its reference product. In requiring different suffixes for biosimilars and their reference products, FDA seeks to help physicians and pharmacists distinguish between the products to “minimize inadvertent substitution” and, more generally, to “facilitate pharmacovigilance for all biological products.”
PROS VS. CONS
Proponents of FDA’s approach argue that distinguishing between biosimilars and their reference products will help avoid industry confusion and prevent adverse reactions in patients who could otherwise be unknowingly switched from a reference product to a biosimilar. Some biotech drugmakers have stressed the safety risks of inadvertently switching patients to alternate versions of biologics, emphasizing that biosimilars are not perfect copies of their reference products.
Critics of the approach, however, contend that biosimilars should carry a name identical to their brand-name counterparts in order to lessen confusion about the safety and efficacy of biosimilars and to facilitate increased use of and access to cost-saving biosimilars in the marketplace.
THE REMAINING QUESTION FOR INTERCHANGEABLES
FDA’s proposed rule also contemplates naming
for interchangeables. An interchangeable is a type of biologic that has been
shown to meet certain Public Health Service Act standards enabling it to be
substituted for its reference product without requiring intervention from the
prescribing healthcare provider, meaning that pharmacists may freely substitute
interchangeables with their reference products. To be interchangeable, a
product must demonstrate biosimilarity and produce the same result as
the reference product in any given patient without any increased risk in terms
of safety or diminished efficiency. FDA requested comments on and is still considering
whether interchangeables should share the same name as their reference
products, or whether a distinguishing suffix should also be required for such
products.[3]
[1] 42 U.S.C. § 262 (i)(2)(A); Public Health Service Act § 351(i)(2).
[2] FDA, Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability, 80 FR 52296, 52297 (Aug. 28, 2015).
[3] Id. at 52296; see also PHS Act at § 351(i)(3).
Finis
