European approval opens the door for Grastofil

Neutrophile segmented Granulocyte

Neutrophile segmented Granulocyte (Photo credit: Wikipedia)

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.

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.

A biosimilar is a drug with a protein produced by biotechnological process as an active pharmaceutical ingredient and developed in comparison to an original product which is already on the market, and that is so similar to this original product that the biosimilar has proven therapeutic equivalence.

Ariana-Leilani suffers from Severe Chronic Neutropenia — where her neutrophil levels are at life threatening low levels making her prone to fatal infection.   She needs medicine to control her condition.  Please sign her petition:

GoPetition for ariana-leilani

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