HOW is quality assured for the manufacture of biopharmaceuticals?
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. Biosimilar medicines are manufactured according to the latest state-of-the-art technology, ensuring the highest quality standards available. It requires a high degree of specialised expertise and the establishment of an expensive technological background. Biosimilar medicines are usually better characterised than their reference products were characterised at the time of their approval 10 or 20 years earlier.
