STADA to market Grastofil in Europe

November 5, 2013 10:22 AM

STADA Arzneimittel AG has strengthened its activities in the biosimilars area and in-licensed a filgrastim product from the largest Canadian owned pharmaceutical company Apotex Inc.

The biosimilar, marketed under the name Grastofil, received approval from the European Commission for the treatment of Neutropenia in adults. The condition results in an abnormally low number of neutrophil granulocytes, a type of white blood cell that is essential for a functional immune system. STADA shall assume sales of the biosimilar for nearly all EU countries. Sales are planned to commence in 2014.

“With Grastofil, we are consequently following our strategy of selectively in-licensing biosimilars from high-profile partners,” says Dr. Michael Mack, Vice President of Biotechnology at STADA. “The agreement with Apotex puts us in the position to expand our portfolio with a high-quality biosimilar at very favorable conditions. STADA brings its excellent international sales structures and comprehensive experience in the European market to the cooperation, which both partners will benefit from.”

Grastofil will be available in pre-filled syringes with two different active ingredient concentrations for intravenous or subcutaneous injection. “The effectiveness, tolerability and quality of Grastofil are comparable to the original product within the approved area of application,” explains Mack. “This was proven in comprehensive, comparative studies with the original product and has now been confirmed with the approval of the European Commission. With Grastofil, we will be able to offer an inexpensive alternative therapy in the future that doctors, patients and even the public health care system will benefit from.”

Neutropenia can arise as a result of cytotoxic chemotherapy, for example. Grastofil promotes the generation of neutrophil granulocytes and their release from the bone marrow and, therefore, can be used to support chemotherapy for malignant diseases in order to reduce the risk of neutropenia-induced infection as well as to support the antibiotic treatment of this type of infection. The approval also comprises the application to mobilize peripheral blood stem cells.

 

Source: STADA press release

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