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

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In a move that will likely be welcomed by industry, the US FDA issued draft guidance stating that sponsors will generally not need to conduct comparative clinical immunogenicity studies in developing biosimilar/interchangeable products.

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for the US market will generally not need to conduct comparative clinical immunogenicity studies, according to draft guidance issued by the to Food and Drug Administration on 25 November.

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More from Biosimilars & Generics

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