Biograstim is a biological medicinal product similar to the reference product Neupogen authorized in the EU. Studies have shown Biograstim to have a comparable quality, safety and efficacy profile to Neupogen (filgrastim). A pharmacovigilance plan for Biograstim, as for all medicinal products, will be implemented as part of the marketing authorization.
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.
Biograstim is also 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.