WHAT is the regulatory approval process for biosimilar medicines in Europe?
All biotechnology medicines, including biosimilar biotechnology-derived medicines, are or will be assessed by the European Medicines Agency in London (EMEA), which constitutes the scientific body of the European Commission responsible for the evaluation of medicines. They are approved by the European Commission based on the positive scientific opinion issued by the EMEA. When the EMEA assesses data for a biosimilar medicine, the scientific principles for ensuring product quality, safety and efficacy are identical to those applied to the originator/brand reference medicine with which comparability is demonstrated. In addition to the quality data required for all biotechnology products, the companies involved in the developing biosimilar medicines must additionally submit comparability data. Indeed, manufacturers must characterise, in parallel, both their biosimilar product and the originator reference product. They must demonstrate, with a high degree of certainty, that the quality of t
