Biologics

Our Concerns Regarding Congressional Proposal to Discard Public Quality and Safety Standards for Biologics

Biologics Standards Proposal

For a hundred years, federal law has required that all drugs adhere to public quality standards—part of ensuring safety and protecting the public’s health. Language that would exempt biologics, including biosimilars, from adhering to the same public quality standards as other prescription medicines was recently added to the FDA and NIH Workforce Authorities Modernization Act. Learn about the potential impact this biologics quality exemption may have on competition, product development, and the public's confidence in biologics and biosimilars.

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New USP Standards for Characterization of Therapeutic Proteins

New USP Standards for Proteins

Learn about and view the new suite of physical and written standards that USP is developing to help biologics manufacturers develop and analyze therapeutic proteins. New general chapters address analytical procedures for monoclonal antibodies, oligosaccharides, and protein determination.

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The Evolving Role of Glycosylation Analysis for Biopharmaceuticals

New USP standards for glycosylation analysis

Learn about the evolving and challenging role of glycosylation analysis in biopharmaceutical science and how USP documentary and reference standards can support advances in this field.

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