Biosimilar Insulins (Generally) Won't Need Comparative Clinical Immunogenicity Data, US FDA Says
Executive Summary
In a move that will likely be welcomed by industry, the US FDA issued draft guidance stating that sponsors will generally not need to conduct comparative clinical immunogenicity studies in developing biosimilar/interchangeable products.
You may also be interested in...
FDA Official Foresees Reduced Biosimilar Data Burden
New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.
Biosimilars: Deep Product Understanding Will Move Regulators To Reduce Clinical Data Requirements, US FDA Official Says
New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.
Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity
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.