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First biosimilar from Ulm close to approval

The era of biopharmaceuticals is in sight for ratiopharm, Germany’s second largest generics producer. Only recently, the Ulm-based company received a positive assessment from the EU regulatory body EMEA in London for the first filgrastim biosimilar. The company expects to receive marketing authorisation for its first biosimilar by mid to end April and regards this as a milestone in company history.

The drug is biotechnologically produced in E. coli and is used for the treatment of different types of neutropenia and for the mobilisation of stem cells. Filgrastim is a drug that boosts the formation of white blood cells. It is mainly used in cancer patients who have undergone chemotherapy in order to prevent potentially fatal infections. Some cancer drugs not only destroy tumour tissue but they also destroy white blood cells that are important for the defence against inflammation.

The first filgristim biosimilar is produced in Ulm (Photo: ratioharm)
Preclinical and clinical development was coordinated by Mannheim-based BioGeneriX, a ratiopharm subsidiary established in 2000. The subsidiary ratiopharm direct will handle the marketing and sales of the biosimilar and Merckle Biotec will be in charge of the production of the first Ulm biosimilar.

The market for biosimilars (in America also referred to as follow-on biologics) is regarded as strongly expanding since the first generation of biotech proteins, including insulin, growth hormone (somatrotropin), interferon, G-CSF (granulocyte colony-stimulating factor) and erythropoietin have either already lost patent protection or will expire in the near future. Experts estimate that the top-selling biotherapeutics will lead to annual sales revenues of more than 2 billion US dollars up until 2010.

Source: ratiopharm, 21.02.2008 (P) (wp, pers. information, 17.03.2008)
Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/first-biosimilar-from-ulm-close-to-approval