Last week, the Food and Drug Administration (FDA) published a draft guidance – “Labeling for Biosimilar and Interchangeable Biosimilar Products” (2023 Draft Guidance).
Once finalized, this will revise and replace the earlier guidance from July 2018 entitled “Labeling for Biosimilar Products”. By issuing this new guidance, the FDA aims to utilize the invaluable experience accumulated from its earlier approval process involving 42 biosimilar products, which included four interchangeable biosimilar products.
For those unfamiliar with the subject matter, biosimilar products are biologic medicines that are similar, but not identical, to a reference product. The interchangeable biosimilars however, are not only similar to the reference product but also meet additional regulatory criteria, allowing them to be substituted for the reference product without the healthcare provider’s intervention.
The 2023 Draft Guidance is designed to assist manufacturers by providing detailed labeling instructions that are perceived to be necessary for the unique nature posed by these products. The availability of this draft guidance indicates FDA’s growing emphasis on the importance of proper labeling to ensure safe usage and to potentially minimize prescribing errors or patient confusion regarding the use of biosimilars.
While this new guidance is not yet finalized and may be subject to change, its release implies a positive step forward by FDA in considering and addressing the challenges linked to biosimilar product labeling.