About biosimilar

general data

On biosimilar medicines

Biosimilar pharmaceuticals are biological medicines that are, or will soon be, no longer protected by patents. Biological medicines (also called "biopharmaceuticals") are biotechnology-derived medicines whose active ingredient is produced from living organisms, such as plant or animal cells, bacteria, viruses and yeast.

Biosimilars are as safe and effective as the originator biological medicine. They follow the specific provisions of EU legislation which include defined high standards of quality, safety and efficacy. Standards of the EU Good Manufacturing Practice (GMP) apply to the manufacture of biosimilar medicinal products in the same way as for any other biological medicinal product. Compliance with the EU GMP Guidelines is verified during routine GMP inspections by the EU national competent authorities.

Biosimilar medicinal products have been used safely in clinical practice in the European Union since 2006 and their market share has been growing at different rates across both EU Member States and product categories.

Biosimilar medicinal products may offer a less-costly alternative to existing biological medicinal products that have lost their exclusivity rights. The availability of biosimilar medicinal products enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of EU healthcare systems. Thus, their availability offers potential economic benefit to EU healthcare systems while addressing the issue of new treatment options brought about by advances in medical science.

For further information, please access the web page on "Information on Biosimilar medicines" of the Medicines for Europe Asociation's webpage