Biosimilars

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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USP and Synthetic Therapeutic Peptides

USP and SyntheticTherapeutic Peptides

Anita Szajek, Ph.D., principal scientific liaison to USP’s Expert Panel on Therapeutic Peptides, examines therapeutic peptides, the transition from recombinant to synthetic manufacturing routes, and regulatory and quality-related questions.

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Pharmaceutical Compliance: A Conversation with Chuck Bates

Pharmaceutical Compliance Manager

There’s a chance you may work in pharma and not know about USP, but rest assured your compliance manager does. What, exactly, does your compliance manager do?  How does he or she interact with USP?  To find out, we asked award-winning source Charles “Chuck” Bates from Sandoz—recent recipient of the Novartis Group Advanced Sciences & Technologies-Quality Control Award for Individual Commitment to Excellence.

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