Tag: biosimilars vs generics

Lot-to-Lot Variability in Biologics and Biosimilars: What You Need to Know +
16 Jan

Lot-to-Lot Variability in Biologics and Biosimilars: What You Need to Know

Lot-to-lot variability is normal in biologics and biosimilars due to their complex production using living cells. Unlike generics, biosimilars aren't identical copies but highly similar versions. The FDA ensures safety through rigorous testing, and labs must verify reagent lots to avoid clinical errors.