Under the licensing agreement – financial terms of which were not disclosed – Germany-based Stada will sell Apotex’ product Grastofil (filgrastim) – which is a version of the Amgen blockbuster Neupogen - in Europe starting in 2014.
The drug's active ingredient - filgrastim - is a protein analog of granulocyte colony-stimulating factor (G-CSF) that is used to stimulate the proliferation of white blood cells in cancer patients whose immune systems have been damaged by chemotherapy.
A spokeswoman for the European Medicines Agency (EMA) told BioPharma-Reporter.com that Grastofil was approved by the European Commission (EC) last week and added that: "We will publish a European Assessment Report (EPAR) setting out the scientific grounds for the Committee's opinion in favour of granting the marketing authorisation in due course."
When launched Grastofil will be one of a number of biosimilar versions of filgrastim to be sold in Europe behind Sandoz’ Zario, Filgrastim Hexal by Hexal and Hospira’s Nivestim. However, Stada’s Patrick Meschenmoser told BioPharma-reporter.com that the generics firm is not worried about competition.
“As a company, Stada has proved in the past that it can compete very successfully in highly competitive markets with its products” said Meschenmoser citing Silapo, a biosimilar version of the anaemia drug epoetin zeta marketed by the firm’s subsidiary cell pharma, as an example.
“Here, too, competitors already have been in the market and we could hold our own with great success. We are very confident that we can provide our expertise in the marketing of biosimilars in the case of Grastofil once again.
“Our experience and well established structures in almost all European markets create - in conjunction with this high-quality product by Apotex - ideal conditions for a successful launch.”
Like the Amgen original, all biosimilar versions of filgrastim currently on the market are produced in modified E.coli cells in which the human gene for G-CSF has been inserted.
Apotex –which will be responsible for manufacturing Grastofil was not available for comment ahead of publication.
News that a new version of filgrastim will soon be available in Europe was welcomed by charity Cancer Research UK.
Director of clinical research Kate Law told BioPharma-Reporter.com that: “The availability of a biosimilar drug to treat neutropoenia is likely to be positive news for patients and the NHS as it broadens the options for a disease which is challenging to treat using many chemotherapy regimens.”