FDA Publishes Immunogenicity Guidelines For Biosimilar Insulins
Biosimilar Insulins Generally Will Not Need Comparative Clinical Immunogenicity Data
In a move that will likely be welcomed by industry, the US FDA has issued draft guidance stating that sponsors will generally not need to conduct comparative clinical immunogenicity studies in developing biosimilar/interchangeable products.
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US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.
Approaches suggested at a US FDA public hearing include allowing follow-on insulins to take a direct route to interchangeability without first having to be approved as biosimilars, and automatically declaring biosimilar insulins interchangeable with one or more reference products.