Pegfilgrastim Biosimilars: Where Are We Now?

Selby, Christopher; Peyton-Thomas, Breanne; Eslami, Parnian

doi:10.6004/jadpro.2021.12.5.9

Cited by 6 publications

(3 citation statements)

References 16 publications

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“…In addition to improved access, biosimilars have also altered the landscape of CIN management by stimulating marketplace competition and fostering innovative research and drug development. Biosimilars are altering the management of CIN by reducing costs for both patients and healthcare systems [17,18 ]. One estimate is that biosimilars have a potential cost-saving benefit of $54 billion over 10 years [19].…”

Section: Guidelines and Biosimilarsmentioning

confidence: 99%

The impact of new and emerging agents on outcomes for febrile neutropenia: addressing clinical gaps

Crawford

Oswalt

2023

Current Opinion in Oncology

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Purpose of reviewWhile chemotherapy treatment options for patients with solid and hematologic malignancies have dramatically improved over recent years, chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) remain major barriers to delivering treatment at full doses and optimal timing. Despite concurrent advances in granulocyte colony-stimulating factor (G-CSF) administration, multiple barriers to the administration of and disparities in the access to these agents remain. The introduction of new, emerging agents, including biosimilars and novel therapies show promise in improving outcomes for CIN.Recent findingsThe introduction of biosimilar filgrastim products has improved access to G-CSF administration by driving marketplace competition and has reduced costs for both patients and healthcare systems without sacrificing efficacy. Emerging therapies to address similar issues include long-acting G-CSF products, efbemalenograstim alfa and eflapegrastin-xnst, as well as agents with novel mechanisms of action, plinabulin and trilaciclib. These agents have shown efficacy and cost-saving benefits in certain populations and disease groups.SummaryMultiple emerging agents show promise in decreasing the burden of CIN. Use of these therapies will reduce access disparities and will improve outcomes for patients with cancer receiving cytotoxic chemotherapy. Many ongoing trials are underway to evaluate the roles of these agents for more widespread use.

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Section: Guidelines and Biosimilarsmentioning

confidence: 99%

The impact of new and emerging agents on outcomes for febrile neutropenia: addressing clinical gaps

Crawford

Oswalt

2023

Current Opinion in Oncology

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“…This drug has been approved for pediatric use by the United States Food and Drug Administration ( Zamboni, 2003 ; Hu et al, 2021 ). Although several pegfilgrastim biosimilars and the third-generation rhG-CSF efbemalenograstim alfa have been approved for clinical application, their approvals were primarily based on adult data ( Harbeck et al, 2016 ; Glaspy et al, 2017 ; Waller et al, 2019 ; Moosavi et al, 2020 ; Selby et al, 2021 ; Glaspy et al, 2024 ).…”

Section: Introductionmentioning

confidence: 99%

Efficacy, safety, and cost-effectiveness of pegylated PEG-rhg-CSF in pediatric patients receiving high-intensity chemotherapy: results from a phase II study

Huang,

Zhu,

Jiang

et al. 2024

Front. Pharmacol.

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BackgroundHigh-intensity chemotherapy can cause life-threatening complications in pediatric patients. Therefore, this study investigated safety and efficacy of long-acting pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF; Jinyouli®) in children undergoing high-intensity chemotherapy.MethodsTreatment-naive patients received post-chemotherapy PEG-rhG-CSF as primary prophylaxis for two cycles. The primary endpoints were drug-related adverse events (AEs) and bone pain scores. Secondary endpoints included grade 3–4 neutropenia, duration of neutropenia recovery, absolute neutrophil count changes, febrile neutropenia (FN), reduced chemotherapy intensity, antibiotic usage, and AE severity. The cost-effectiveness of PEG-rhG-CSF was compared with that of rhG-CSF (Ruibai®).ResultsHere, 307 and 288 patients underwent one and two PEG-rhG-CSF cycles, respectively. Ninety-one patients experienced drug-related AEs, primarily bone pain (12.7%). Moreover, Grade 3–4 neutropenia and FN were observed. Median FN durations were 3.0 days in both cycles. No drug-related delays were observed during chemotherapy. One patient experienced grade 4 neutropenia-induced reduction in chemotherapy intensity during cycle 2. In total, 138 patients received antibiotics. PEG-rhG-CSF exhibited superior cost-effectiveness compared to rhG-CSF.ConclusionOur findings indicate that PEG-rhG-CSF is safe, efficient, and cost-effective in pediatric patients undergoing high-intensity chemotherapy, providing preliminary evidence warranting further randomized controlled trials.

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“…First developed by Amgen, pegfilgrastim was approved by the U.S. Food and Drug Administration (FDA) in 2002 and marketed as Neulasta® [ 8 ]. Armlupeg (Lupin’s Pegfilgrastim) was developed as a biosimilar to the reference, U.S.-licensed Neulasta®.…”

Section: Introductionmentioning

confidence: 99%

Analytical sameness methodology for the evaluation of structural, physicochemical, and biological characteristics of Armlupeg: A pegfilgrastim biosimilar case study

Deshmukh,

Goyal,

Sundaram

et al. 2023

PLoS ONE

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Pegfilgrastim is administered as an adjunct to chemotherapy to reduce the incidence of febrile neutropenia and associated infectious complications. Lupin’s Pegfilgrastim is a proposed biosimilar to the U.S.-referenced Neulasta®. Demonstration of biosimilarity requires extensive physicochemical and functional characterization of the biosimilar, and demonstration of analytical similarity to the reference product, in addition to clinical studies. This work is a case study for demonstrating the analytical similarity of Armlupeg (Lupin’s Pegfilgrastim) to Neulasta® with respect to structural and physicochemical attributes using several robust, orthogonal, and state-of-the-art techniques including high-end liquid chromatography, mass spectrometry, and spectroscopy techniques; circular dichroism; differential scanning calorimetry; nuclear magnetic resonance; analytical ultracentrifugation; and micro-flow imaging. Functional similarity was demonstrated using an in vitro cell proliferation assay to measure relative potency and surface plasmon resonance to measure receptor binding kinetics. Furthermore, comparative forced-degradation studies were performed to study the degradation of the products under stress conditions. The product attributes were ranked based on a critical quality attributes risk score according to their potential clinical impact. Based on criticality, all analyses were statistically evaluated to conclude analytical similarity. Lupin’s Pegfilgrastim was comparable to Neulasta® as demonstrated via structural, functional, and purity analyses. Lupin’s Pegfilgrastim complied with the quality and statistical ranges established using Neulasta®. Both products follow the same degradation pathways under stress conditions as observed in the forced-degradation studies. No new impurity or degradation product was observed in Lupin’s Pegfilgrastim. These data conclusively demonstrate the analytical similarity of Lupin’s Pegfilgrastim and Neulasta®.

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Pegfilgrastim Biosimilars: Where Are We Now?

Cited by 6 publications

References 16 publications

The impact of new and emerging agents on outcomes for febrile neutropenia: addressing clinical gaps

The impact of new and emerging agents on outcomes for febrile neutropenia: addressing clinical gaps

Efficacy, safety, and cost-effectiveness of pegylated PEG-rhg-CSF in pediatric patients receiving high-intensity chemotherapy: results from a phase II study

Analytical sameness methodology for the evaluation of structural, physicochemical, and biological characteristics of Armlupeg: A pegfilgrastim biosimilar case study

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