Biosimilars Video Resource Summary
Functional Testing of Biosimilars
This is an educational biosimilars resource provided by Organon.
Transcript:
After confirming a biosimilar’s structural similarity to its reference biologic, the process of validation moves to confirming that it functions the same way as well. The functional elements of a biologic relate to its mechanism of action.
The mechanism of action refers to how the drug works in the body. Functional data help confirm that the product works via the same biochemical pathways as the reference biologic and it can help predict some of the potential clinical effects of the molecule.
Functional testing helps prove that the biosimilar works through the same biochemical mechanisms.
Researchers testing a biosimilar’s functionality compare results to the functional critical quality attributes of the reference biologic. The biosimilar must demonstrate a high degree of similarity to the functional results from the reference biologic with no clinically meaningful differences.
Functional testing helps prove that the biosimilar works through the same biochemical mechanisms and can potentially show highly similar clinical effects to the reference biologic.
It’s a key step in the multifactorial validation process for biosimilars.
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.
Clinical testing video
One-minute video describing the important steps during the clinical testing phase of the rigorous biosimilar approval process.
