chapter  Chapter 4
22 Pages

EMA-approved biosimilars

WithSarfaraz K. Niazi

In the European Union, a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency and not nationally. Omnitrope is a human growth hormone product derived from recombinant DNA processes. Human growth hormone is a single-chain, 191 amino acid, nonglycosylated protein. The original marketed versions of human growth hormone were derived from the pituitary glands of human cadavers. The hyaluronidases are enzymes that break down hyaluronic acid and chondroitin. Hyaluronidase injection is indicated for use to increase the absorption and dispersion of other injected drugs and for related uses. Granulocyte-colony stimulating factor or filgrastim is a naturally occurring cytokine produced by endothelial cells, macrophages, and other immune cells. Sandoz GmbH applied for a marketing authorization for Omnitrope 1.3 and 5.0 mg/mL powder for solution for injection. Omnitrope 1.3 and 5.0 mg/mL contain recombinant human somatropin as active substance.