Tags : Interchangeable

Biosimilars

The US FDA Draft New Guidelines for Proposed Biosimilars and

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