Biograstim

Withdrawn

This medicine's authorisation has been withdrawn

filgrastim

Overview

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The European public assessment report (EPAR) for Biograstim is updated to indicate that the marketing authorisation is no longer valid.

Biograstim : EPAR - Summary for the public

Product information

Biograstim : EPAR - Product Information

Biograstim : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Biograstim
• Active substance:
  filgrastim
• International non-proprietary name (INN) or common name:
  filgrastim
• Therapeutic area (MeSH):
  • Hematopoietic Stem Cell Transplantation
  • Cancer
• Anatomical therapeutic chemical (ATC) code:
  L03AA02

Pharmacotherapeutic group

Colony stimulating factors

Therapeutic indication

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000826
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation holder:
  AbZ-Pharma GmbH

  Graf -Arco-Strase 3; 99079 Ulm; Germany

• Marketing authorisation issued:
  15/09/2008
• Withdrawal of marketing authorisation:
  23/09/2015
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Biograstim : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Biograstim : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Biograstim

Reference Number: EMEA/CHMP/371648/2008