Shots: The FDA has released draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act” The draft guidance is intended to inform […]readmore
Tags : Draft
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 […]readmore
Shots: The company submitted report for the FDA’s guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products clarifying the clinical immunogenicity study for the approval of certain proposed […]readmore
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 […]readmore