EGA Press Release

Friday, 26 September 2008 | Brussels

EGA WELCOMES APPROVALS OF BIOSIMILAR FILGRASTIM

The EGA welcomes the European Commission’s Decision approving four new similar biological medicinal products for marketing in the European Union. The four new medicines contain recombinant human Granulocyte-Colony Stimulating Factor (G-CSF) as their active substance, which is also known under the international non-proprietary name (INN) filgrastim.

Biograstim®, from CT Arzneimittel, Filgrastim ratiopharm® and Ratiograstim®, from ratiopharm, and TevaGrastim®, from Teva Generics are biological immuno-stimulating medicinal products and all have been shown to have a comparable quality, safety and efficacy profile to Amgen’s Neupogen® (filgrastim). They are intended for the treatment of neutropenia, which is defined as an abnormally low number of a certain type of white blood cells in the body.

The Commission’s Decision follows on from the positive scientific opinions issued by their scientific body, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

According to Greg Perry, director general of the EGA, “These new approvals demonstrate once more that the EU framework for biosimilar medicines has solid scientific and legal grounds and is fully operational. Nine EU companies have so far obtained marketing authorisations for biosimilar medicines which confirms the strength of our industry’s biotechnology R&D capabilities. Our biosimilar medicines sector is also expected to contribute significantly to reducing the price of healthcare in the EU.”

To continue these in-roads, the EGA is engaged in an ongoing constructive dialogue with the European Medicines Agency, and the 2nd EMEA-EGA Info Day will take place on 3 October. “This meeting will give the generic and biosimilar medicines industry a unique chance to exchange views directly with regulators, which will further contribute to facilitating the regulatory pathway”, said Mr Perry.

Suzette Kox, senior director scientific affairs of the EGA, also welcomes Amgen’s latest position regarding the interchangeability of all erythropoietins in the German market. An article published in the Financial Times Germany on 20 August 2008(1) reported Amgen as having stated that EPOs available in Germany could “in principal all be used as therapeutically equivalent for the treatment of anaemia”. Amgen’s assessment originally appeared in a written motion for a preliminary injunction at the Land Court of Düsseldorf in June.

“We welcome any news that Amgen no longer opposes the interchangeability of biosimilar EPOs. This shows that the science which underpins biosimilar approvals is finally being acknowledged in the market place. This will also contribute to ending the current potential for confusion amongst patients and healthcare professionals. Interchangeability of biosimilar medicines should be based on the scientific data published via the European Public Assessment Report (EPAR)”, said Ms Kox.

Footnotes

1. Kuchenbuch, Peter, US-Pharmakonzern fordert im Kampf um deutsche Rabattverträge europaweite Ausschreibung; Originalpräparat und Kopien sollen gleich gestellt worden, Financial Times Germany (FTD), 20 August 2008.

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