FDA vs. EMA Biosimilar Approvals, an Update

In 2026, the number of EMA-approved and FDA-approved biosimilar drug categories are now even. However, the number of marketed US biosimilars is less than half of that in the EU. When looking at the approvals by the European Medicines Agency (EMA) of biosimilars since the initial approval back in 2006 for somatropin biosimilar, it becomes … Continue reading FDA vs. EMA Biosimilar Approvals, an Update