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2025-06-13|

Biologics Derived from Living Organisms and Biosimilars Approved Through Rigorous Testing

by Mark Chiang
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Biopharmaceutical products have significantly impacted the medical field, offering new ways to prevent and treat diseases that were once considered untreatable or fatal. Despite their growing presence, questions remain about these treatments, including the distinction between biologics and biosimilars.

Biologics are complex medicines derived from living organisms such as cells or tissues. They are used to treat a wide range of conditions, including autoimmune disorders, cancers, and rare diseases. Biosimilars, on the other hand, are highly similar versions of already-approved biologic drugs. While not identical due to the inherent variability in biological production processes, biosimilars match their reference biologics in terms of safety, potency, and efficacy. Regulatory agencies require rigorous testing to ensure biosimilars meet these standards before approval for clinical use.

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Date: September 22, 2023

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