FDA issues draft guidance on biosimilars naming

The US Food and Drug Administration has released draft guidance on biosimilar medicines naming conventions.

The FDA proposes that US biosimilar medicines are distinguished from their brand-name counterparts by the addition of a suffix to their generic name. This would help pharmacists from mistaking one drug for another in cases where the FDA has stated that the therapies are not interchangeable. The agency has not yet established whether biosimilars that are considered interchangeable would require a unique suffix or share the same as the branded product.

The reference product and the biosimilar would be given a suffix of four letters, unique to each, which will have no special meaning. The FDA is considering how to implement this retrospectively for biologics it has already approved, and has suggested a rule where previously-licensed biologics would be given a non-proprietary name with a suffix.