HOW can patients be assured of quality?
Both originator reference products and biosimilar medicines are made under carefully controlled conditions to ensure the products are consistent and of the required quality. This is known as Good Manufacturing Practice (GMP). In the European Union, GMP inspections for all biopharmaceuticals — originator reference products and biosimilar medicines — are coordinated by the EMEA and performed by the national regulatory agencies.
Both originator reference products and biosimilar medicines are made under carefully controlled conditions to ensure the products are consistent and of the required quality. This is known as Good Manufacturing Practice (GMP). In the European Union, GMP inspections for all biopharmaceuticals — originator reference products and biosimilar medicines — are coordinated by the EMA and performed by the national regulatory agencies. There are three levels: • Routine GMP inspections of manufacturing sites to ensure that medicines are produced safely and correctly. • Pre-Approval Inspections (PAI) for GMP compliance prior to the approval of new medicines for marketing if there are specific issues identified during the approval process. • Unannounced inspections.
