Update on biosimilars of granulocyte colony-stimulating factor – when no news is good news

Schulz, Miriam; Bönig, Halvard

doi:10.1097/moh.0000000000000204

Cited by 6 publications

(4 citation statements)

References 37 publications

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“…All currently available formulations are administered as a subcutaneous injection. For recognised indications, there is no demonstrable difference in efficacy or safety between different formulations or bio-similar agents (Schultz and Bonig, 2016). In this analysis, we included treatment with any of the currently available formulations or bio-similar agents.…”

Section: Definition Of Rechallenge Neutropenia and G-csfmentioning

confidence: 99%

Use of granulocyte-colony stimulating factor to prevent recurrent clozapine-induced neutropenia on drug rechallenge: A systematic review of the literature and clinical recommendations

Myles

Clark

Bird

et al. 2017

Aust N Z J Psychiatry

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Background: Clozapine is the most effective medication for treatment-refractory schizophrenia; however, its use is contraindicated in people who have had previous clozapine-induced neutropenia. Co-prescription of granulocyte-colony stimulating factor may prevent recurrent neutropenia and allow continuation or rechallenge of clozapine.Objective and methods: Systematic review of literature reporting the use of granulocyte-colony stimulating factor to allow rechallenge or continuation of clozapine in people with previous episodes of clozapine-induced neutropenia. The efficacy of granulocyte-colony stimulating factor and predictors of successful rechallenge will be determined to elucidate whether evidence-based recommendations can be made regarding the use of granulocyte-colony stimulating factor in this context. Results:A total of 17 articles were identified that reported on clozapine rechallenge with granulocyte-colony stimulating factor support. In all, 76% of cases were able to continue clozapine at median follow-up of 12 months. There were no clear clinical or laboratory predictors of successful rechallenge; however, initial neutropenia was more severe in successful cases compared to unsuccessful cases. Cases co-prescribed lithium had lower success rates of rechallenge (60%) compared to those who were not prescribed lithium (81%). The most commonly reported rechallenge strategy was use of filgrastim 150-480 µg between daily to three times a week. There were no medication-specific side effects of granulocyte-colony stimulating factor reported apart from euphoria in one case. Three cases who failed granulocytecolony stimulating factor had bacterial infection at time of recurrent neutropenia. No deaths were reported. Conclusion:Preliminary data suggest granulocyte-colony stimulating factor is safe and effective in facilitating rechallenge with clozapine. Clinical recommendations for use are discussed.

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Section: Definition Of Rechallenge Neutropenia and G-csfmentioning

confidence: 99%

Use of granulocyte-colony stimulating factor to prevent recurrent clozapine-induced neutropenia on drug rechallenge: A systematic review of the literature and clinical recommendations

Myles

Clark

Bird

et al. 2017

Aust N Z J Psychiatry

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“…Once regulators are convinced of the evidence provided, the marketing authorization will be issued for all licensed indications of the reference product (“extrapolation”). Proposed benefits of biosimilars include reduced health care expenditure and, at least in less affluent countries, improved access …”

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confidence: 99%

Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte‐colony‐stimulating factor: safety, efficacy, and graft performance

et al. 2016

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BACKGROUND Biosimilar granulocyte‐colony‐stimulating factors (G‐CSFs) have been available in the European Union since 2008, and Sandoz' biosimilar filgrastim was approved in the United States in March 2015 for all of the reference product's indications except acute radiation syndrome. Biosimilar G‐CSFs have been largely embraced by the medical community, except for some reservations about healthy‐donor stem cell mobilization, for which use outside of clinical studies was cautioned against by some members of the scientific community. STUDY DESIGN AND METHODS In a two‐center safety surveillance study (National Clinical Trial NCT01766934), 245 healthy volunteer stem cell donors were enrolled. Of 244 donors who began mobilization with twice‐daily Sandoz biosimilar filgrastim, 242 received a full (n = 241) or partial (n = 1) course of G‐CSF and underwent apheresis. Efficacy and safety were assessed and are reported here. RESULTS Biosimilar filgrastim was accompanied by the typical G‐CSF class‐related adverse effects of expected frequency and severity. Median mobilization for CD34‐positive stem cells was 97/µL (range, 20‐347/µL); after one apheresis (91%) or two aphereses (9%) from all but three donors (1.2%), cell doses in excess of the typical 4 × 106 CD34‐positive cells/kg of the recipient had been collected (range, 3‐52 × 106/kg). Biochemical and hematologic alterations were consistent with previous reports; all had normalized by the first follow‐up 1 month after mobilization. Stem cell products engrafted with typical probability and kinetics for G‐CSF‐mobilized stem cell products. CONCLUSION These data support the use of biosimilar filgrastim for healthy‐donor stem cell mobilization as safe and effective.

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“…The top two were guidelines for management of clinical conditions (rheumatoid arthritis and febrile neutropenia). This could be explained because three biosimilars are available to treat rheumatoid arthritis and others are in the way to approval [ 30 ], and the recent approval process of granulocyte-colony stimulating factor biosimilars, a useful drug to treat febrile neutropenia [ 31 ]. Moreover, clinical practice guidelines from any field generally have a lot of cites.…”

Section: Discussionmentioning

confidence: 99%

A bibliometric analysis of the global research on biosimilars

Hernández-Vasquéz

Alarcón-Ruiz

Bendezú-Quispe

et al. 2018

J of Pharm Policy and Pract

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BackgroundBiosimilars could be a promising option to help decrease healthcare costs and expand access to treatment. There is no previous evidence of a global bibliometric analysis on biosimilars. Therefore, we aimed to assess the quantity and quality of worldwide biosimilars research.MethodsWe performed a bibliometric analysis using documents about biosimilars published until December 2016 in journals indexed in Scopus. We extracted the annual research, languages, countries, journals, authors, institutions, citation frequency, and the metrics of journals. The data were quantitatively and qualitatively analyzed using Microsoft Excel 2013. Additional information about authors' participation was obtained using the R-package Bibliometrix. Publication activity was adjusted for the countries by population size. Also, author co-citation analysis and a term co-occurrence analysis with the terms included in the title and abstract of publications was presented as network visualization maps using VOSviewer.ResultsA total of 2330 biosimilar-related documents identified in the Scopus database, most of them were articles (1452; 62.32%). The number of documents published had an exponential increased between 2004 and 2016 (p < 0.001). The United States was the country with the highest production with 685 (29.40%) documents followed by Germany and UK with 293 (12.58%) and 248 (10.64%), respectively. Switzerland (11.05), Netherlands (5.85) and UK (3.83) showed the highest per capita ratio. The highest citation/article ratio were for the Netherlands (28.06), Spain (24.23), and France (20.11). Gabi Journal published 73 (3.13%) documents; both Biopharm International and Pharmaceutical Technology and Mabs, 41 (1.76%). Three out of top ten journals were Trade publications. Amgen Incorporated from the USA was the most prolific institution with 51 documents followed by Pfizer Inc. with 48. Terms about specific diseases and drugs were found in recent years, compared with terms such as legislation, structure, protein, dose and generic in the early years.ConclusionsResearch production and publication of documents on biosimilars are increasing. The majority of publications came from high-income countries. The trends in terminology use are according to state of the art in the topic, and reflects the interest in the utilization of biosimilars in diseases who are expected to obtain benefits of its use.Electronic supplementary materialThe online version of this article (10.1186/s40545-018-0133-2) contains supplementary material, which is available to authorized users.

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Update on biosimilars of granulocyte colony-stimulating factor – when no news is good news

Cited by 6 publications

References 37 publications

Use of granulocyte-colony stimulating factor to prevent recurrent clozapine-induced neutropenia on drug rechallenge: A systematic review of the literature and clinical recommendations

Use of granulocyte-colony stimulating factor to prevent recurrent clozapine-induced neutropenia on drug rechallenge: A systematic review of the literature and clinical recommendations

Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte‐colony‐stimulating factor: safety, efficacy, and graft performance

A bibliometric analysis of the global research on biosimilars

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