Regulatory Expectations for Stability Testing of Biosimilars
Regulatory Expectations for Stability Testing of Biosimilars Meeting Regulatory Expectations in Stability Testing of Biosimilars Stability testing plays a critical role in the development and lifecycle management of biosimilars. Unlike generics, biosimilars must demonstrate similarity—not identity—to a reference product across structural, functional, and stability attributes. Regulatory agencies such as the FDA, EMA, WHO, and CDSCO…
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