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
 // August 23, 2023

Part One: Industry examining FDA guidance on nitrosamines...

Nitrosamine impurities in pharmaceutical products have been making major headlines recently, as this year has marked the fifth anniversary since they were first detected at unacceptable levels in some blood pressure medications and – even more importantly – due to a flurry of new regulatory activity taking place around the globe this summer, including by the U.S. Food and Drug Administration (FDA). In this two-part Quality Matters blog series, we take a look at the FDA’s recent guidance on nitrosamines and what it means for industry.
Mrunal Jaywant
Naiffer Romero, Principal Scientist
Mrunal Jaywant Naiffer Romero