title: Clinical safety of biosimilar recombinant human granulocyte colony-stimulating factors.
abstract: BACKGROUND
  A 'biosimilar', or 'similar biological medicinal product', is a biologic agent that is similar in terms of quality, safety and efficacy to an authorized reference biological medicine. Since the expiration of the filgrastim patent in Europe, three agents have received marketing authorization from the EMA: Tevagrastim, Zarzio and Nivestim. Tevagrastim has also been approved as a biologic by the FDA as tbo-filgrastim.
  
  
  METHODS
  Using the EMA dossiers (all three agents), the FDA dossier (Tevagrastim), and journal publications, this article reviews clinical safety data for these products with emphasis on serious/severe adverse events and special consideration of immunogenicity, bone pain, splenomegaly, allergic reactions, acute respiratory distress syndrome and mortality.
  
  
  CONCLUSIONS
  All three agents have similar safety profiles. None were statistically higher on safety parameters to what is known about originator filgrastim (Neupogen). What is known about filgrastim in general regarding safety can be extended to biosimilar filgrastim. Safety profiles may become more differentiated once long-term product-specific safety data are available. Large-sample, long-term, observational studies of real-world practice will provide the heterogeneity and statistical power to demonstrate product-specific safety profiles. Current evidence indicates that statistically no one product is less and no one product is more safe.
authors: University of Arizona, College of Medicine, College of Pharmacy, Center for Health Outcomes and PharmacoEconomic Research, Department of Pharmacy Practice and Science, Department of Family and Community Medicine, 1295 N. Martin Ave., Tucson, AZ 85721, USA. abraham@pharmacy.arizona.edu
authors: Ivo
authors: I
authors: Abraham
authors: Soba
authors: S
authors: Tharmarajah
authors: Karen
authors: K
authors: MacDonald
mesh_terms: D000818:Animals; D001688:Biological Products / Q000009:adverse effects* / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects* / Q000627:therapeutic use; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D010146:Pain / Q000139:chemically induced; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012128:Respiratory Distress Syndrome / Q000139:chemically induced
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor