The submission of the application and labelling for proposed biosimilar or proposed interchangeable biosimilar for fewer than all the reference product’s licensed condition of use The submission of supplement to an application for a biosimilar or proposed interchangeable product was licensed for fewer than all the reference products Timing for the submission of a 351(k) […]Read More
Shots: The objective of this guideline is to provide recommendations on when and whether a comparison clinical immunogenicity study is required for biosimilar and interchangeable insulin products targeted to treat Type 1 or Type 2 diabetes mellitus The US FDA stated that if an analytical study is based on state-of-the-art technology supporting “highly similar” for […]Read More
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