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Published on 14 January 2009

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First biosimilar approved for the treatment of neutropenia

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Ratiopharm direct has launched the first biosimilar non glycosylated recombinant N-methionyl human granulocyte colony stimulating factor, following approval by the European Medicines Agency (EMEA).

Ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with chemotherapy for malignancy and the reduction in duration of neutropenia in patients undergoing myeloblative therapy followed by bone marrow transplantation at risk of severe neutropenia.

Ratiograstim counteracts the depletion of some white blood cells and helps prevent potentially fatal infections in patients with these conditions.

As one of the new generation of off patent biopharmaceuticals or biosimilars, Ratiograstim has been granted marketing authorisation following a rigorous regulatory process designed to ensure quality, efficacy and tolerability as well as bioequivalence. Ratiograstim approval is based on clinical trials with approximately 900 patients.

Randomised, single blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacodynamic and pharmacokinetic profile of Ratiograstim was comparable to that of the reference product, Neupogen, from Amgen, after subcutaneous and intravenous administration.

A multinational, multicentre, randomised, controlled study in 350 patients with breast cancer who received chemotherapy showed comparable safety and efficacy profiles for Ratiograstim versus Neupogen.

Two further trials in patients with lung cancer and non Hodgkin lymphoma similarly showed comparable safety and efficacy profiles.

Ratiograstim is presented in a prefilled syringe containing 300mcg filgrastim in 0.5ml solution and 480mcg filgrastim in 0.8 ml solution for injection or infusion.

Biosimilars such as Ratiograstim are a valuable emerging source of affordable medicines as the Minister of State at the Department of Health, Dawn Primarolo, acknowledged in the House of Commons earlier this year: “Biotechnology is an important and growing field within modern medicine…properly licensed biosimilar medicine increase the number of such drugs available to patients and clinicians.”

With proven quality and efficacy, Ratiograstim affords an additional benefit in providing an alternative choice, contributing to health service cost savings, and helping to increase the potential availability of other more cost effective medications.

Dr Heinz Lubenau, head of development for ratiopharm direct explains: “As global leaders in the development of biosimilar medicines we have invested 80million euros in the development of this product alone and have a strong pipeline of biosimilar products scheduled for launch in the next few years.

“We are committed to providing healthcare professionals with high quality but affordable alternatives in this highly complex and challenging pharmaceutical arena.”

Ratiopharm



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