Biologics and biosimilars – the basics
Biologics
 // June 17, 2024

Biologics and biosimilars – the basics

Biologic medicines – “biologics” for short. You’ve probably seen commercials for some of them on TV. Maybe you or someone you know is even taking one. But what exactly are they? And what about “biosimilars” ? You might also be wondering whether they’re safe and effective. 

U
USP Staff
Biologics and biosimilars – the basics
Biologics
 // June 17, 2024

Biologics and biosimilars – the basics

Biologic medicines – “biologics” for short. You’ve probably seen commercials for some of them on TV. Maybe you or someone you know is even taking one. But what exactly are they? And what about “biosimilars” ? You might also be wondering whether they’re safe and effective. 

U
USP Staff

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Medicines Supply Chain
Supply Chain
 // November 27, 2023

Building a More Resilient Medicines Supply Chain

Building a More Resilient Medicines Supply Chain

In this Q&A with the Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium, US Pharmacopeia (USP) policy expert Amy B. Cadwallader highlights the importance of multi-disciplinary, cross-functional coordination to strengthen the medicine supply chain and global public health resilience in the face of ongoing threats, like persistent drug shortages. This Q&A was first published in the Consortium's eNewsletter and is re-printed with the permission of the Duke-Margolis Center for Health Policy.

Amy Cadwallader
Amy Cadwallader
Researcher holding pharmaceuticals in lab
Medicines
 // November 27, 2023

Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA fram...

USP’s Naiffer Romero has teamed up with researchers at LHASA Limited, AstraZeneca, Sai Life Sciences and Merck for collaborative research on nitrosamines impurities that was published this month in the Journal of Pharmaceutical Sciences. Quality Matters recently sat down with Romero, who leads USP’s Nitrosamines Exchange, to learn more about the new research and what it means for the field.
Naiffer Romero, Principal Scientist
Naiffer Romero
Child taking cough syrup
Supply Chain
 // September 21, 2023

Ensuring Product Safety: U.S. FDA Guidance on Testing High-Risk Drug Components for D...

Excipients, or inactive ingredients, in a drug formulation are critical components, comprising up to 90% of a drug formulation by volume and serving important functions such as improving stability and increasing bioavailability for targeted drug delivery. However, with so much focus on the quality of active ingredients in the complex pharmaceutical supply chain, the quality of inactive ingredients is, at times, overlooked.
Y
Catherine Sheehan, DRSc., MS, MS
J
Yognandan Pandya Dr. Catherine Sheehan Jenny (Tong) Liu