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

Biosimilars Video Resource Summary

Structural Testing of Biosimilars

This one-minute video describes the important steps during the structural testing phase of the rigorous biosimilar approval process.

This is an educational biosimilars resource provided by Organon.

Transcript:

Biosimilars are created based on an existing, approved biologic. The process begins when researchers catalog the reference biologic’s critical quality attributes (CQAs). Structural CQAs define key attributes of the reference biologic.

It’s only when the molecules have highly similar structures that a biosimilar and its reference biologic can have similar therapeutic properties.

Biologics are complex molecules, and their structure is one of the most important determinants of their function. A single change to an important structural element may cause an otherwise similar molecule to behave differently. It’s only when the molecules have highly similar structures that a biosimilar and its reference biologic can have similar therapeutic properties.
Using structural CQAs as benchmarks, researchers compare the 2 molecules using rigorous laboratory tests. Researchers must show that each structural CQA of the biosimilar is highly similar to the corresponding attribute of the reference biologic, to show the proposed biosimilar will function in a similar manner. For this reason, structural similarity is foundational in development.

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