This site is intended for U.S. health care professionals.
This site is intended for U.S. health care professionals.

Biosimilars Video Resource Summary

Rigorous Approval Process of Biosimilars

This one-minute video for health care professionals covers the rigorous biosimilar approval process.

This is an educational biosimilars resource provided by Organon.

Transcript:

To demonstrate that the biosimilar and the reference biologic have no clinically meaningful differences in terms of safety, purity, and potency, the FDA established the biosimilar development process.

The result is a drug with no clinically meaningful differences in safety, purity, and potency.

STEP 1: ANALYSIS

First, by analyzing the reference biologic, the critical quality attributes (CQAs) of the molecule are identified. These CQAs become the blueprint for the biosimilar, and they’re used for validation throughout the process.

STEP 2: DEVELOPMENT

Next, cell lines are developed to generate molecules that resemble the reference biologic. The optimal line is selected to become the biosimilar molecule’s production source.

STEP 3: TESTING

Researchers test the biosimilar to ensure that it demonstrates no clinically meaningful differences from the reference biologic.

STEP 4: FDA APPROVAL

Finally, the FDA grants its approval based on a thorough analysis of the available data.
The result is a drug with no clinically meaningful differences in safety, purity, and potency. It can be expected to have similar treatment benefits and potential side effects and the same dosing and administration as the reference biologic, providing a rigorously tested alternative, at a potentially lower cost for the health care system.

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