The US Food and Drug Administration (FDA) released a draft guidance giving drug manufacturers recommendations for biosimilar and interchangeable biosimilar products, detailing tips for drafting label prescription information, on 15 September.
In the “Labeling for Biosimilar and Interchangeable Biosimilar Products” document, the agency said that “the biosimilar or interchangeable biosimilar label should only be used in labelling text that is specific to the biosimilar or interchangeable biosimilar product or refers solely to it.”
The FDA defines an interchangeable biosimilar as a “biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy, depending on state pharmacy laws.”
The agency guided drug manufacturers to only include the drug product’s proprietary name in the following sections: indications and usage, dosage and administration, dosage forms and strengths, description and how supplied/storage and handling. The FDA also recommended its use in recommendations for preventing, monitoring, managing, or mitigating risks.
The FDA also differentiated when it is appropriate to refer to the reference drug in biosimilar labelling. It stated that all approaches to reference product labelling should be evaluated on a case-by-case basis that will consider the drug’s context of use.
Manufacturers should also make it clear when the biosimilar had only received licensure for a select number of the reference product’s approved treatment areas, said the organisation. Furthermore, a clear statement stating the therapy’s biosimilarity was suggested as a part of the label.
According to the FDA, biosimilars are the fastest-growing class of medications in the US, providing patients with more affordable healthcare options. The regulator offers an abbreviated approval process for biosimilar and interchangeable biosimilar therapies.
The FDA has approved two biosimilars this year so far. This includes Sandoz’s Tysabri (natalizumab) biosimilar Tyruko and Celltrion’s Humira (adalimumab) biosimilar Yuflyma.
The FDA has said that it will accept comments surrounding the guidance until 18 December 2023. The guidance document will replace the agency’s July 2018 “Labeling for biosimilar products” guidelines once it becomes finalised.
