Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim

Škrlin, Ana; Radić, Ivan; Vuletić, Marko; Schwinke, David L.; Runac, Domagoj; Kusalic, T.; Paškvan, Ivan; Krsic, M.; Bratos, M.; Marinc, Sabina

doi:10.1016/j.biologicals.2010.05.002

Cited by 52 publications

(35 citation statements)

References 15 publications

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“…All stages of the preclinical and clinical development of Hospirafilgrastimwerecarefullydesignedinaccordancewith EMAguidelines [8][9][10].Asaresult,aseriesofrigorousanalyseshavenowdemonstratedthebioequivalenceofHospirafilgrastimandAmgenfilgrastimintermsoftheirphysicochemicalproperties,pharmacokineticandpharmacodynamiccharacteristics,andclinicalefficacyandsafetyprofiles [13,14,26]. EMA guidelines support the extrapolation of clinical data from one therapeutic indication to another, assuming that reasonablejustificationcanbemadefollowingconsideration of clinical experience, current literature, similarity of the mechanismsofaction,andanypossiblesafetyissuesindifferentpatientsubpopulations [9,10].Therefore,Hospirafilgras-…”

Section: Conflict Of Interestmentioning

confidence: 99%

“…To address this issue, the European Medicines Agency (EMA) has recommended guidelines for the development of biosimilars [8][9][10][11][12]. The development program for Hospira filgrastim was carefully designed to fulfil these guideline requirements and ensure bioequivalence with Amgen filgrastim in terms of quality, safety,andefficacy.PreclinicalandphaseIstudiessupported thephysicochemical,pharmacokinetic,andpharmacodynamic bioequivalence of Hospira filgrastim and Amgen filgrastim [13,14,26].Furthertotheseencouragingearlierstudies,we report the results of a phase III, randomized, double-blind, therapeutic equivalence study designed to evaluate the efficacyandsafetyofHospirafilgrastimversusAmgenfilgrastim forthepreventionofneutropeniainpatientsreceivingmyelosuppressivechemotherapyforbreastcancer.…”

Section: Introductionmentioning

confidence: 99%

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A Phase III Randomized Equivalence Study of Biosimilar Filgrastim versus Amgen Filgrastim in Patients Receiving Myelosuppressive Chemotherapy for Breast Cancer

et al. 2010

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Background: Filgrastim was developed to treat chemotherapy-induced neutropenia. This phase III study was designed to demonstrate bioequivalence of Amgen filgrastim and a biosimilar filgrastim developed by Hospira (Study GCF071; sponsored by Hospira). Patients and Methods: Breast cancer patients suitable for treatment with doxorubicin and docetaxel in the neoadjuvant/adjuvant or first-line metastatic setting were enrolled at 37 European centers. Patients were randomized (2:1) to receive Hospira filgrastim or Amgen filgrastim, after the end of chemotherapy. Filgrastim (5 µg/kg/day) was administered under double-blind conditions. Primary endpoint to demonstrate bioequivalence was duration of severe neutropenia (DSN) in cycle 1. Results: 184 patients were randomized to Hospira filgrastim and 95 to Amgen filgrastim. Mean DSN in cycle 1 was similar with Hospira filgrastim (1.6 days; n = 165) and Amgen filgrastim (1.3 days; n = 85), meeting predefined criteria for bioequivalence. Secondary endpoints supporting bioequivalence included mean time to absolute neutrophil count recovery and incidence of febrile neutropenia. The most common treatment-related adverse event with Hospira filgrastim was grade 1–2 bone pain. Conclusions: Hospira filgrastim and Amgen filgrastim are bioequivalent in efficacy with similar safety profiles. Hospira filgrastim may be useful for the prophylaxis of complications related to neutropenia caused by chemotherapy.

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Section: Conflict Of Interestmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Phase III Randomized Equivalence Study of Biosimilar Filgrastim versus Amgen Filgrastim in Patients Receiving Myelosuppressive Chemotherapy for Breast Cancer

et al. 2010

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“…Once comparability of the primary structure is confi rmed, higher -order structure of the protein can be confi rmed by activity assays, circular dichroism ( CD ) spectroscopy, and nuclear magnetic resonance ( NMR ) spectroscopy (Locatelli and Roger, 2006 ;Skrlin et al, 2010 ). NMR is generally applicable to small proteins.…”

Section: Toxicity and Preclinical Assessmentmentioning

confidence: 99%

Improving the Pharmaceutical Properties of Biologics in Drug Discovery: Unique Challenges and Enabling Solutions

Chen¹,

Dongre²

2012

ADME‐Enabling Technologies in Drug Design and Development

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“…L'étude de cas des deux biosimilaires du GCSF recombinant humain concerne Zarzio ® et Nivestim ® , biosimilaires développés respectivement par Sandoz et Hospira [5][6][7][8][9]. Le produit de référence utilisé pour le développement de ces deux biosimilaires est Neupogen ® , le filgrastim développé par Amgen.…”

Section: Développement Technique D'un Médicament Biosimilaireunclassified

What is a biosimilar? How far does the similarity go?

Gravel¹,

Cotonnec²

2011

Oncologie

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Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim

Cited by 52 publications

References 15 publications

A Phase III Randomized Equivalence Study of Biosimilar Filgrastim versus Amgen Filgrastim in Patients Receiving Myelosuppressive Chemotherapy for Breast Cancer

A Phase III Randomized Equivalence Study of Biosimilar Filgrastim versus Amgen Filgrastim in Patients Receiving Myelosuppressive Chemotherapy for Breast Cancer

Improving the Pharmaceutical Properties of Biologics in Drug Discovery: Unique Challenges and Enabling Solutions

What is a biosimilar? How far does the similarity go?

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