Biosimilar Insulins (Generally) Won't Need Comparative Clinical Immunogenicity Data, US FDA Says

25 Nov 2019

• By Michael Cipriano

In a move that will likely be welcomed by industry, the US FDA issued draft guidance stating that sponsors will generally not need to conduct comparative clinical immunogenicity studies in developing biosimilar/interchangeable products.

insulin hormone vials-single use syringe_1200x675 — The US FDA is proposing streamlining development of biosimilar/interchangeable insulins.

Companies developing biosimilar and interchangeable insulin products for the US market will generally not need to conduct comparative clinical immunogenicity studies, according to draft guidance issued by the to Food and Drug Administration on 25 November.

The draft guidance, which will likely be welcomed by industry, notes that, "Current analytical tools used to evaluate quality...