Poor Biosimilarity Practices, Impurities and New Technologies Debated At European Pharmacopoeia Event
Executive Summary
Some regulators are wrongly using monographs rather than a biosimilarity exercise to show comparability of a biosimilar with its reference product, it was suggested at the European Pharmacopoiea’s latest conference. Also discussed were issues such as how to align the PhEur with the new ICH guideline on elemental impurities, and how advances in technology are being dealt with.