May 2019: VelaLabs authorized for release testing of Grasustek Biosimilar in Europe
In April 26, 2019, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use recommended the granting of a marketing authorization for the pegfilgrastim biosimilar Grasustek. Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) filgrastim. Grasustek was developed by the Indian company USV Ltd. and the application for its approval was submitted to EMA by USV subsidiary Juta Pharma, Germany. USV, as a long-term client of VelaLabs, has authorized us for handling the release testing package of the product.