Free course on "FDA overview of Biosimilars"

USFDA is offering a web-based free course on biosimilars. The course provides an understanding of biological products and biosimilar products and a description of FDA’s general approach to the development and approval of biosimilar products. The target audience for this course is healthcare professionals, including physicians, physician assistants, nurses, nurse practitioners, and pharmacists.

The course comprises eight different modules:
Module
Title
1
Introduction
2
Biologics Price Competition and Innovation (BPCI) Act of 2009
3
What is a biological product?
4
Complexity of Biological Product Manufacturing
5
What is a similar Product?
6
Abbreviated Approval Pathway for Biosimilar Products
7
Standards for Approval
8
Conclusion






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