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First ratiopharm biosimilar to enter European market

The Ulm-based company ratiopharm has been given approval by the EU regulatory office, EMEA, for its filgrastim biosimilar, the first biosimilar to be marketed by the company, which will now be launched in the fourth quarter of 2008. The company has already applied for market authorisation of another genetically engineered pharmaceutical.

Approval has been given for the use of filgrastim for the treatment of certain types of neutropenia (the reduction of neutrophile granulocytes in the blood), and the mobilisation of peripheral blood stem cells. The active ingredient, a granulocyte colony-stimulating factor (G-CSF), counteracts the depletion of white blood cells during chemotherapy cancer treatment, and prevents potentially fatal infections in patients who suffer from neutropenia.

Ten years of research preceded the approval of the drug

Biopharmaceuticals are not as easy to engineer as chemical substances. (Photo: ratiopharm)
Ratiograstim is a filgrastim biosimilar that took almost ten years of research and development to gain approval. The Mannheim-based ratiopharm subsidiary BioGenerix managed preclinical and clinical development, and the ratiopharm subsidiary Merckle Biotec is responsible for production.

According to information supplied by ratiopharm, the approval of biosimilars is subject to the same high standards as the original product. The approval of Ratiograstim involved large-scale phase I and III clinical trials with around 880 probands and patients suffering from stage II to IV breast cancer, lung cancer and non-Hodgkin lymphomas all of whom were undergoing chemotherapy with cytostatic drugs. In the multi-centre phase III trials, Ratiograstim proved to be comparable to the reference product in terms of efficacy and safety. Antibody tests also revealed an immunogenicity profile that was similar to the reference product.

First biopharmaceutical in the company’s portfolio

“This first biosimilar to be launched on the market by the ratiopharm Group is backed by 125 years of experience in research and development and underlines ratiopharm’s position as an innovative generics company,” said Oliver Windholz, CEO of the ratiopharm Group.

The company did not disclose any information on the price of the biosimilar. Market observers envisage cost reductions of 15 to 20 per cent compared to the original product when it first enters the market. Since many first-generation biotech drugs are about to lose their patent protection, this business sector is generally regarded as extremely lucrative. The European market for EPO biosimilars alone is estimated at around two billion dollars.

Source: ratiopharm Group, 16 September 2008
(P, wp, 22 September 2008, pers. information)
Website address: https://www.gesundheitsindustrie-bw.de/en/article/press-release/first-ratiopharm-biosimilar-to-enter-european-market