Tag: pharmacovigilance

Biosimilar Safety Monitoring: How Adverse Events Are Tracked and Managed

Biosimilars aren't like generics. They need special safety monitoring due to their complex structure. This article explains how adverse events are tracked, challenges in reporting, and how regulators are adapting. Real-world examples and future improvements in biosimilar safety surveillance.

Real-World Evidence Sources for Drug Safety: Registries and Claims Data

Registries and claims data are two key sources of real-world evidence used to monitor drug safety after approval. They help catch rare side effects, track long-term outcomes, and support regulatory decisions with data from millions of real patients.