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Quality by design with a focus on biosimilars

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For more information, please download our white paper.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. What is a Biosimilar?

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