European perspective on biosimilars

“Although dogged by much controversy, the scientific approach adopted in the EU for approval of biosimilars to ensure patient safety has been sound.” Patent expiration of several blockbuster biotechnology-derived proteins over the last decade has meant that similar biological medicinal products (commonly termed ‘biosimilars’) have become a reality in the EU. Since 2006, 14 products including growth hormone, granulocyte colony-stimulating factor and erythropoietin have been granted marketing authorization via the biosimilar route in the EU, and many are in the pipeline. These products have demonstrated similarity to their respective reference (innovator) products on the basis of a rigorous comparability exercise...