Biograstim
Withdrawn
filgrastim
Medicine
Human
Withdrawn
On 23 September 2015, the European Commission withdrew the marketing authorisation for Biograstim (filgrastim) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AbZ Pharma GmbH, who notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Biograstim was granted marketing authorisation in the EU on 15 September 2008 for treatment of neutropenia. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity. Biograstim is a biosimilar medicine of the reference medicinal product Neupogen and Biograstim was authorised in the EU for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for reducing the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation who were considered to be at increased risk of prolonged severe neutropenia.
Additional indications of Biograstim include mobilising peripheral blood progenitor cells (PBPC) in graft donors, increasing neutrophil counts and reducing the incidence and duration of infection-related events in patients with severe congenital, cyclic, or idiopathic neutropenia, and treating persistent neutropenia in patients with advanced HIV infection.
The European public assessment report (EPAR) for Biograstim is updated to indicate that the marketing authorisation is no longer valid.
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Product information documents contain:
Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.