FDA Overview of Biosimilar Products
This continuing education 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 health care professionals, including physicians, physician assistants, nurses, nurse practitioners, pharmacists, and pharmacy technicians.
FDA's Overview of the Regulatory Framework and FDA’s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US
Recorded presentation to help FDA Advisory Committee members and Special Government Employees better understand the regulatory framework and key concepts of the development process of biosimilar and interchangeable products.
FDA Basics Webinar: Biological Products, Part 1
Part 1 in a series, this webinar provides an overview of biological products and how they differ from small molecule drugs. Originally posted June 17, 2013.
FDA Basics Webinar: Biological Products, Part 2: Biosimilar Biological Products
Part 2 in a series, this webinar addresses biosimilar biological products. Originally posted August 19, 2013.
From our perspective: Biosimilar product labeling
Blog by Dr. Leah Christl discussing FDA’s approach to biosimilar product labeling.
From our perspective: Interchangeable biological products
Article by Dr. Leah Christl discussing the draft guidance for developing interchangeable biological products
Biosimilars in the US: Progress and Promise (PDF - 268KB)
Presentation by Dr. John Jenkins on FDA’s biosimilar program and key concepts and lessons learned to this point.
The Brave New World of Biosimilars
Interview with Dr. Leah Christl discussing the key issues with biosimilars that health care professionals need to understand.
Biosimilar Biological Products: 2013 Clinical Investigator Course (PDF - 294KB)
Presentation discussing biologics, biosimilars, safety, and study design considerations in biosimilar development.
Update on the Development and Approval of Biosimilar Products: Where Are We Now & Where Are We Headed? (PDF - 682KB)
Presentation on the status of biosimilar development programs, FDA-issued guidance, and ongoing challenges.
Overview of the Regulatory Pathway and FDA’s Guidance for the Development and Approval of Biosimilar Products in the US (PDF - 299KB)
Presentation by Dr. Leah Christl about the development and approval pathway for biosimilars in the United States.