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In a move that will likely be welcomed by industry, the US FDA has issued draft guidance stating that sponsors will generally not need to conduct comparative clinical immunogenicity studies in developing biosimilar/interchangeable products.
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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.
Biosimilar Substitution: US State Laws Require Physician Communication And, In Some Cases, Lower Prices
Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but six states. Interactive map notes state-by-state provisions.