Biosimilars Video Resource Summary
Clinical Testing of Biosimilars
This is an educational biosimilars resource provided by Organon.
Transcript:
After demonstrating strong similarities through structural and functional comparison to an approved reference biologic, the FDA requires clinical testing as part of their approval criteria.
Comparative clinical data provide validation in human subjects to support that the biosimilar has no clinically meaningful differences from the reference biologic. This includes how the biosimilar is absorbed by, distributed to, and eliminated from the body. It’s also assessed on how it interacts with and affects the body.
Comparative clinical data analyzed from human trials is used to validate that the biosimilar has no clinically meaningful differences from the reference biologic in humans.
No meaningful differences
Ultimately, clinical data reinforce laboratory data by confirming there are no clinically meaningful differences in safety, purity, and potency between the biosimilar and the reference biologic.
Related Biosimilars Resources
Rigorous approval video
One-minute video for health care professionals that covers the rigorous biosimilar approval process.
Structural testing video
One-minute video describing the important steps during the structural testing phase of the rigorous biosimilar approval process.
Functional testing video
One-minute video describing the important steps during the functional testing phase of the rigorous biosimilar approval process.
