Neumax (filgrastim biosimilar) / Fresenius Kabi - LARVOL DELTA

Demonstration of physicochemical and functional similarity between Stimufend (pegfilgrastim-fpgk) and Neulasta (pegfilgrastim): A comparative analytical assessment. (PubMed, PLoS One) - "The findings of this study provide robust evidence supporting the structural and functional biosimilarity between Stimufend® and Neulasta®."

Clinical • Journal • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Oncology

IMMUNOPHENOTYPING OF PERIPHERAL BLOOD MONONUCLEAR CELLS COLLECTED BY APHERESIS (EBMT 2024) - "All patients received a standard mobilization protocol with filgrastim (G-CSF) or G-CSF plus plerixafor... Although HSCTs have been performed as a standard of care for many disorders, little is known about the effects of mobilization and apheresis collection on the graft MNC composition, which may impact the transplant outcomes. Therefore, further studies are required to verify its effects on engraftment kinetics and its clinical implications"

Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Transplantation

"CMS grants Fresenius Kabi permanent, product-specific Q-Code for Stimufend® (pegfilgrastim-fpgk) https://t.co/5Dg9F5seah" (@NewsFromBW)

"Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Stimufend® (pegfilgrastim - fpgk) https://t.co/cwRPEoDP5h" (@NewsFromBW)

FDA event

[VIRTUAL] COLLECTION OF GRANULOCYTE CONCENTRATES BY APHERESIS WITHOUT HYDROXYETHYLAMIDE. IS IT WORTH IT? (HEMO 2021) - ", gender, pre-collection WBC, volume processed in each procedure, bag volume collected and the number of granulocytes collected per unit. For the collections, we used the COM.TECH equipment (Fresenius Kabi) and the donors were mobilized 12 to 16h before collection with 8 mg VO of dexamethasone and 300 mcg/SC of filgrastim.Results Comparing the 10 GC collections with and without HES the means obtained were as follows: age (33.4 vs. 39.5 years); gender (9 males and 1 female vs. 10 males); weight (81 vs. 92 kg); height (1.74 vs. 1.77 m); pre-collection leukometry (37.18 vs. 31.39 ×103 leukocytes/microliters), processed volume (8575 vs. 9473 mL), collected bag volume (367 vs. 363 mL), granulocyte count in the product (3, 15 vs. 2.42 × 1010granulocytes/unit). The GC collected without HES had an average of 23.2% less granulocytes/unit. Discussion In the GC collections without HES, the average volume processed was higher because we could..."

Hematological Disorders • Infectious Disease • Neutropenia

"Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by EMA (@EMA_News) https://t.co/Z18T1NA0H1 @FreseniusKabi" (@Fresenius)

PHARMACOKINETIC/PHARMACODYNAMIC ASSESSMENT OF A PROPOSED PEGFILGRASTIM BIOSIMILAR MSB11455 VERSUS THE CURRENTLY LICENSED PEGFILGRASTIM: A RANDOMIZED, DOUBLE-BLIND TRIAL (MASCC-ISOO 2019) - P1; "PK/PD equivalence of MSB11455 and pegfilgrastim was demonstrated with comparable immunogenicity, safety, and tolerability. This study supports the biosimilarity of MSB11455 to Neulasta®"

Clinical • PK/PD data