apotheke adhoc: STADA launches generic Bortezomib in 14 European countries
05/15/2019 - 03.21 PM . Information
Berlin – STADA introduces a Bortezomib generic in 14 European countries. The innovation: In contrast to the original preparation Velcade from Janssen-Cilag, the new product no longer needs to be dissolved before processing.
Bortezomib STADA is available as an injection solution with 2.5 mg/ml Bortezomib and corresponds in its qualitative composition to the original Velcade after reconstitution of the powder. This saves the specialist staff in the pharmacies one production step. The aim is to increase safety in dosage and handling.
The injection solution is stored under light protection in the refrigerator and has a shelf life of 27 months. Velcade is stored at room temperature until reconstitution. According to the manufacturer, a change in storage temperature is not unusual for medicines whose formulation is changed from a "dry product" such as Velcade (lyophilisate) to a solution.
The information on the so-called in-use stability – i.e. after opening the vial or manufacturing a syringe with the patient's individual dose - is identical to the information provided by the originator: After opening the solution must be processed and applied immediately, as the shelf life is only eight hours here too.
STADA introduces Bortezomib in Germany, Belgium, France, Great Britain and the Netherlands. For CEO Peter Goldschmidt, Bortezomib is one of the most important international product launches in the history of STADA thanks to its clear added value. "With this development, we have succeeded in giving patients early access to a cost-effective alternative to the originator product. At the same time, we offer pharmaceutical professionals an additional benefit".
Bortezomib is used for the treatment of multiple myeloma. The active ingredient is the first proteasome inhibitor. Bortezomib blocks the metabolic pathways of uncontrolled proliferating cancer cells by blocking proteasomes. This inhibits the breakdown of proteins in the cell (proteolysis). Cancer cells react more sensitively to this blockade than normal body cells, so that tumour growth is inhibited.
Velcade was introduced in 2004 and was prescribed 74,000 times in 2017 according to the Drug Prescription Report. The expenses for the health insurance funds amounted to 115 million euros. Bortezomib is administered subcutaneously or intravenously and is used in various therapy regimens, including in combination with melphalan, rituximab, cyclophosphamide and cortisone preparations.
Translated by STADA Corporate Communications