Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
February 7, 2020
April 9, 2020
8f893384-8971-47a4-9e54-aea227852806
Related Documents
Labeling for Biosimilar and Interchangeable Biosimilar Products
Guidance DocumentSeptember 18, 2023Center for Drug Evaluation and Research
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
Guidance DocumentJuly 23, 2024Center for Drug Evaluation and Research
Nonproprietary Naming of Biological Products: Update Guidance for Industry
Guidance DocumentMarch 8, 2019Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox