Fast Facts About the Regulatory Approval Pathway for Biosimilars – Amgen Science

This video provides a high-level overview of the regulatory approval pathway that ensures the safety and effectiveness of biosimilars.

In jurisdictions with robust regulatory standards, such as the US, the approval pathways for biosimilars, while distinct from the pathway for originator biologics, are rigorous and scientifically appropriate. Like all biologics, biosimilars are highly complex, and thus, require scientifically rigorous regulatory approval standards to ensure the safety and effectiveness of biosimilars, just as they do for reference products.

Learn more about biosimilars development:
https://www.insidebiosimilars.com/about/

About Amgen:
https://www.amgen.com/

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Видео Fast Facts About the Regulatory Approval Pathway for Biosimilars – Amgen Science канала Amgen