Comparison of biosimilar filgrastim with originator filgrastim for peripheral blood stem cell mobilization and engraftment in patients with multiple myeloma undergoing autologous stem cell transplantation

Pham, Tina; Patil, Sushrut; Fleming, Shaun; Avery, Sharon; Walker, Patricia; Wei, Andrew H.; Curtis, David J.; Stuart, Georgia; Klarica, Daniela; O’Brien, Maureen E.; Morris, K. R.; Das, Tongted; Bollard, G M; Muirhead, Jenny; Coutsouvelis, John; Spencer, Andrew

doi:10.1111/trf.13233

Cited by 15 publications

(10 citation statements)

References 7 publications

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“…Retrospective, single-center study comparing Hospira biosimilar filgrastim ( n = 60) with ref filgrastim ( n = 38) for autologous SCM in pts with MM [66]…”

Section: Biosimilar Filgrastim Phase III Clinical Datamentioning

confidence: 99%

Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

et al. 2019

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Biosimilar filgrastim (Sandoz) was approved in Europe in 2009 and, in 2015, was the first biosimilar approved in the USA. These authorizations were based on the "totality of evidence" concept, an approach that considers data from structural and functional characterization and comparability analysis and non-clinical and clinical studies. For biosimilar filgrastim, phase III confirmatory clinical studies were performed in the most sensitive population, patients with breast cancer undergoing myelosuppressive chemotherapy. In Europe and the USA, approval was granted for all indications of the reference biologic. Hence, stem cell mobilization and severe chronic neutropenia indications were approved on the basis of extrapolation, with no clinical data available at the time of market authorization in the EU. Although extrapolation is well-accepted in biologic development and regulatory contexts, it remains a misunderstood part of the biosimilarity concept in the medical community. Since approval, more than a decade of obtained clinical experience supports the totality of evidence and reassures clinicians regarding the efficacy and safety of biosimilar filgrastim. This includes real-world data from MONITOR-GCSF, a multicenter, prospective, observational study describing treatment patterns and clinical outcomes of patients with cancer (n = 1447) receiving biosimilar filgrastim for the prophylaxis of chemotherapy-induced neutropenia in solid tumors and hematological malignancies. Evidence is also available from unrelated healthy donors and those with severe chronic neutropenia. Together, the experience from a decade of use of biosimilar filgrastim includes over 24 million patient-days of exposure, which can help reassure oncologists that extrapolation is based on strong scientific evidence and works in practice.

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“…Retrospective, single-center study comparing Hospira biosimilar filgrastim ( n = 60) with ref filgrastim ( n = 38) for autologous SCM in pts with MM [66]…”

Section: Biosimilar Filgrastim Phase III Clinical Datamentioning

confidence: 99%

Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

et al. 2019

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“…Previous studies have shown that the use of biosimilar filgrastim offers cost savings with similar efficacy when compared to the innovator product 17,18 . These findings and the apparent lack of differences in activity or safety between the innovator and biosimilar filgrastim products 4,[8][9][10][11]15 support the use of biosimilar filgrastim in clinical practice.…”

Section: Discussionmentioning

confidence: 79%

“…The fact that no data were collected systematically beyond D6 does not allow concluding that a lower total dose of filgrastim administered in our patients explains the differences in the mean number of CD34+ cells harvested. Higher CD34+ cell yields have been reported in other studies with biosimilar filgrastim, 9,11,16 but whether this is due to differences in the filgrastim products, patient profiles, methods for CD34+ quantification, or institutional policies on PBPC mobilization and harvesting remains unclear.…”

Section: Discussionmentioning

confidence: 89%

“…In the United States, the first filgrastim biosimilar was approved in March 2015 5 , and several filgrastim biosimilars are commercially available in Brazil. Despite the rigorous development and approval processes for biosimilars 6,7 and published evidence that shows no difference in activity between the innovator and biosimilar filgrastim products 4,[8][9][10][11] , concerns have been raised about the efficacy and safety of these products 4,12 . Thus, it is important to assess individual products for their role in clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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Filgrastim Biossimilar para Mobilização de Células Progenitoras antes do Transplante Autólogo: Análise Retrospectiva de Pacientes com Mieloma Múltiplo e Linfomas

Simões¹,

Fogliatto²,

Arcuri³

et al. 2018

Rev. Brasileira.De.Cancerologia

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Introdução: O filgrastim, que desempenha um papel fundamental na coleta de células progenitoras de sangue periférico (CPSP), está disponível há quase 25 anos, e existem vários biossimilares de filgrastim sendo comercializados. Objetivo: Avaliar se um filgrastim biossimilar (Filgrastine®) foi associado com mobilização efetiva em pacientes submetidos à coleta de CPSP para transplante autólogo de medula óssea. Método: Foram revisados os prontuários de pacientes com mieloma múltiplo e linfomas tratados em três instituições no Brasil. O desfecho primário (taxa de sucesso de mobilização) foi a proporção de pacientes na população intenção de tratar (ITT), em que pelo menos 2 x 106 células CD34+/kg foram coletadas por leucaférese nos dias 5 e/ou 6. A população per protocolo (PP) foi composta por pacientes que receberam pelo menos quatro dias de Filgrastine e tiveram pelo menos uma contagem de CD34+ nos dias 5 ou 6. Resultados: A dose diária de Filgrastine (no D1, com pequenas alterações subsequentes) variou de 8,5 a 28,9 mcg/Kg nos 52pacientes na população ITT, com uma mediana de 13,8 mcg/Kg; 51 pacientes receberam pelo menos quatro doses. Uma média de 2,84±1,97 x 106 células CD34+/kg foram coletadas. A taxa de sucesso de mobilização foi de 53,9% (IC 95%, 39,5% a 67,8%) na população ITT e 62,2% (IC 95%, 46,5% a 76,2%) nos 45 pacientes da população PP. A mobilização foi considerada efetiva pelos pesquisadores em 80,8% dos pacientes da população ITT e 88,9% daqueles na população PP. Conclusão: Apesar de sua natureza observacional, este estudo sugere que Filgrastine esteja associado com as taxas de sucesso esperadas na coleta de CPSP para transplante autólogo de medula óssea.

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“…a troca do Remicade para o CT-P13 não trouxe resultados diferentes. Da mesma forma, um estudo na Polônia com 39 crianças demonstrou também que essa mesma troca foi segura e eficaz (Danese et al, Neupogen na mobilização de PBSCs, mas seu uso foi associado a um atraso na recuperação de plaquetas(Pham et al, 2015). CSF novo, de referência.…”

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Avaliação técnico-regulatória dos requisitos de qualidade para registro de medicamentos biológicos e biossimilares humanos: perspectivas e desafios no Brasil

Müller¹

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Comparison of biosimilar filgrastim with originator filgrastim for peripheral blood stem cell mobilization and engraftment in patients with multiple myeloma undergoing autologous stem cell transplantation

Abstract: Nivestim is as effective as Neupogen for PBSC mobilization; however, its use was associated with a delay in PLT recovery. A prospective study should be conducted to confirm our findings.

Cited by 15 publications

References 7 publications

Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

Filgrastim Biossimilar para Mobilização de Células Progenitoras antes do Transplante Autólogo: Análise Retrospectiva de Pacientes com Mieloma Múltiplo e Linfomas

Avaliação técnico-regulatória dos requisitos de qualidade para registro de medicamentos biológicos e biossimilares humanos: perspectivas e desafios no Brasil

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