First biosimilar for the treatment of neutropenia

ULM, Germany | February 21, 2008 | Today ratiopharm receives a positive opinion from the EU regulatory EMEA for the first filgrastim biosimilar. This assessment was issued as anticipated in the context of the EU-wide approval procedure for filgrastim, a so-called Granulocyte Colony-Stimulating Factor (G-CSF). Based on this EMEA recommendation, ratiopharm assumes that approval will be forthcoming this spring. The ratiopharm filgrastim biosimilar will be used in the treatment of different types of neutropenia and to mobilize stem cells. Filgrastim counteracts the depletion of white blood cells and prevents potentially fatal infections in patients with this condition.

The positive opinion for filgrastim is regarded by the ratiopharm Group as a milestone. The comprehensive preclinical and clinical development of the biosimilar was primarily managed by BioGeneriX, a ratiopharm subsidiary. The first filgrastim biosimilar will be sold on the European pharmaceutical market by the subsidiary Ratiopharm Direct.

The ratiopharm Group's involvement in the biosimilars business started at a very early stage. The aim for the corporate group was to manage the complete value-added chain along with the related expertise within its consolidated companies. Establishing the BioGeneriX in 2000 was the first step. This subsidiary focuses on the biopharmaceutical and clinical development of biosimilars. With filgrastim, BioGeneriX marked the successful completion of its product development. Through its Merckle Biotec subsidiary, the ratiopharm Group is also in a position to produce the biotech agent on its own. The Europe-wide marketing and sales of the biosimilar will be handled by the subsidiary ratiopharm direct.

SOURCE: Ratiopharm

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