Biosimilar Development and Manufacturing Processes - Slide Deck
Bronchodilators and Inhaled Corticosteroids - Flashcard
Review the key characteristics, development processes, and regulatory considerations for biologics and biosimilars.
What you'll learn:
- The differences between reference biologics and biosimilars, including their shared and distinct features
- Information on the regulatory approval pathway for reference biologics and biosimilars in the US, including requirements for FDA approval
- The interchangeability and substitution of biosimilars
- The pre-clinical and clinical processes of developing biosimilars, as well as immunogenicity and key considerations for manufacturing biosimilars
Related Resources
Biosimilars - HCP Resource
Biosimilar Interchangeability and Extrapolation - Booklet
Review how biosimilars and interchangeable biosimilars are approved.
View Resource
Biosimilars - HCP Resource
Biosimilar Interchangeability Map
An interactive map detailing interchangeable biosimilar regulations by state.
View Resource
Biosimilars - HCP Resource
Biologics and Biosimilars – Video
A short animated video outlining BI’s commitment to biologics and biosimilars.
View Resource
