Tag: FDA

Lot-to-lot variability is a natural part of biologic and biosimilar manufacturing. Unlike generics, biosimilars aren't identical copies - they're highly similar, with controlled variations that don't affect safety or effectiveness. This is how modern biologics work.

Congress is proposing two bills to tackle drug and healthcare provider shortages, but a historic government shutdown has stalled progress. Here’s what’s in the laws, why they’re stuck, and what it means for patients.