New biosimilar pathways – key takeaways from the EMA’s draft reflection paper
European Pharmaceutical Review
JUNE 19, 2025
The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1 Rather than representing a radical break from established practice, the document builds on decades of scientific and regulatory experience, proposing that – under certain well-defined conditions – the demonstration of bio-similarity might rely more heavily on advanced analytical characterisation and pharmacokinetic (
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