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Cross-sectional patient survey of biological medicine users in Finland to investigate the types of guidance needed by patients in order to carry out their treatment successfully.
BMJ Open
January 2025
Oriola Finland Oy, Espoo, Uusimaa, Finland
Background: The use of new biological medicines as standard treatment is expected to increase substantially and cover new therapeutic indications in the near future. Interchange of biological medicines in pharmacies increases the need for patient guidance.
Objectives: The study aims to gain a patient perspective on biological medicine users' needs and wishes regarding patient guidance by exploring what kind of information patients wish to receive and to further investigate the potential differences in needs between originator biological medicine users and biosimilar users.
Aggregation of human plasma and of human blood induced in vitro by pegfilgrastim originator formulation buffer and pegfilgrastim products.
Eur J Pharm Biopharm
October 2023
NoNO, Toronto, Canada.
PEGylated recombinant human granulocyte colony stimulating factor (pegfilgrastim) is used clinically to reduce the incidence and duration of severe neutropenia in patients who have received chemotherapy treatment. Pegfilgrastim products are administered by subcutaneous injection. We herein report that solutions of pegfilgrastim originator product Neulasta®, of a biosimilar product candidate, and also of the pegfilgrastim originator formulation buffer, induced aggregate formation when mixed in vitro with human plasma, and formation of large membranous aggregated structures when mixed with human blood.
View Article and Find Full Text PDFDemonstration of physicochemical and functional similarity between Stimufend (pegfilgrastim-fpgk) and Neulasta (pegfilgrastim): A comparative analytical assessment.
PLoS One
October 2024
Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.
Background: Pegfilgrastim is a long-acting recombinant human granulocyte colony-stimulating factor biologic that is indicated to reduce the incidence of infections, manifested by febrile neutropenia, in patients receiving myelosuppressive anti-cancer drugs and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. Due to the high cost of biologic therapy and the scarcity of biosimilar alternatives, there is an unmet medical need for targeted biologics.
Objective: This comparative analytical investigation aimed to confirm the similarity of biosimilar Stimufend® (pegfilgrastim-fpgk) to reference product Neulasta® (pegfilgrastim).
Real world comparison of filgrastim to filgrastim-sndz in patients with chemotherapy-induced neutropenia.
J Oncol Pharm Pract
October 2024
Oncology Pharmacy Executive Director, Smilow Cancer Hospital, New Haven, CT 06510.
Article Synopsis
- There is concern among healthcare providers about the safety and effectiveness of biosimilars, particularly due to knowledge gaps and insufficient real-world data on their use, which could affect their acceptance.
- This study aims to assess the healthcare costs, utilization, and clinical outcomes of patients with hematologic malignancies at Yale New Haven Hospital who received either filgrastim-sndz or filgrastim during treatment.
- The study focused on 148 patients meeting specific criteria, including adults with newly diagnosed acute myeloid leukemia or those post-bone marrow transplant, and examined their recovery following chemotherapy or transplantation.
Mecapegfilgrastim for prophylaxis of febrile neutropenia in children and adolescents with rhabdomyosarcoma or Ewing sarcoma: a prospective, single-arm, pilot study.
BMC Cancer
August 2024
Hematology CenterNational Center for Children's HealthKey Laboratory of Pediatric Hematology Oncology, Key Laboratory of Major Diseases in Children, Ministry of Education, Beijing Children's Hospital, Capital Medical University, No. 56 Nanlishi Road, Beijing, 100045, China.
Background: The chemotherapy regimens recommended for both rhabdomyosarcoma (RMS) and Ewing sarcoma (ES) patients are myelosuppressive and can reduce the absolute neutrophil count (ANC) and subsequently increase the risk of febrile neutropenia (FN). However, only a few studies have focused on the efficacy and safety of granulocyte-colony stimulating factor (G-CSF) drugs in pediatric and adolescent patients with RMS and ES. Our objective was to investigate the efficacy and safety of mecapegfilgrastim, a biosimilar of pegfilgrastim, in prophylaxis of FN for pediatric and adolescent patients with RMS or ES.
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