Last week, the US Food and Drug Administration (FDA) unveiled a draft guidance titled “Labeling for Biosimilar and Interchangeable Biosimilar Products”. This guidance, when finalized, will replace and revise the FDA’s July 2018 guidance, “Labeling for Biosimilar Products.” The new draft guidance comes after the FDA approved an impressive 42 biosimilar products, including four interchangeable biosimilar products.
The updated guidance uses recommendations derived from the experience the FDA gained during its approval process of numerous biosimilar products. This valuable insight into labeling considerations is expected to provide a fresh perspective on understanding if a product is biosimilar or interchangeable, though distinguishing the two may prove a challenge.
Biosimilars and interchangeable products are significantly important in the medical field, with each serving distinctive roles in patient care. They are both biologic medicines that are essentially similar to an original ‘reference’ product, yet display a few distinct characteristics. While biosimilars are highly comparable to their reference products, interchangeable products go a step further and can be expected to have the same clinical results as their reference product in any patient.
Implementing clear labeling guidelines comes with a variety of challenges due to the complicated nature of biologics. The balance needs to be struck in providing sufficient information to healthcare professionals, without adding unnecessary complexity. The FDA’s latest draft guidance is a step towards making these distinctions clearer and enhancing understanding among health professionals.