Degree of prescriber’s knowledge about variability in biological drugs “innovators” in manufacturing process

Jiménez-Pichardo, Lucía; Gázquez-Pérez, Rocío; Sierra-Sánchez, Jesús Francisco

doi:10.1007/s00228-017-2397-x

Cited by 11 publications

(7 citation statements)

References 18 publications

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“…The number of infusion-related reactions was low (2.6%), and conforms with our clinical impression that the frequency of infusion reactions with Remicade has decreased over time, which may be related to repeated modifications in the manufacturing process of Remicade. 39 For comparison, the ACCENT I (1999)(2000)(2001) and ACT 1 (2002ACT 1 ( -2005 trials reported infusion reactions in 20.8% and 11.1% of patients, respectively. 27,28 We acknowledge several limitations of the study.…”

Section: Discussionmentioning

confidence: 99%

Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease

Bergqvist

Kadivar

Molin

et al. 2018

Therap Adv Gastroenterol

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Background:As the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn’s disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13.Methods:In this prospective observational cohort study, all adult IBD patients on Remicade treatment, at four hospitals, were switched to CT-P13. The primary endpoint was change in clinical disease activity at 2, 6, and 12 months after the switch. Secondary endpoints were subgroup analyses of patients with and without concomitant immunomodulators; changes in biomarkers, quality of life, drug trough levels and anti-drug antibodies (ADAbs); and adverse events.Results:A total of 313 IBD patients were switched (195 CD; 118 UC). There were no significant changes in clinical disease activity, quality of life, biomarkers (except a small but significant increase in albumin in CD) including F-calprotectin, drug trough levels, or proportion of patients in remission. Disease worsening rates were 14.0% for CD and 13.8% for UC; and 2.7% developed ADAbs and 2.2% developed serious adverse events.Conclusions:This is the largest study of switched IBD patients published to date, and it demonstrates that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in both CD and UC.

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Section: Discussionmentioning

confidence: 99%

Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease

Bergqvist

Kadivar

Molin

et al. 2018

Therap Adv Gastroenterol

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“…Acceptance of biosimilars is now growing across countries as more studies are published demonstrating similar effectiveness and safety between originators and biosimilars coupled with growing knowledge that originator companies themselves regularly change their manufacturing processes [167,[229][230][231][232][233][234]. This builds on the landmark NOR-SWITCH study with infliximab sponsored by the Ministry of Health in Norway [167].…”

Section: Biosimilarsmentioning

confidence: 99%

Evidence-based public policy making for medicines across countries: findings and implications for the future

et al. 2021

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Aim: Global expenditure on medicines is rising up to 6% per year driven by increasing prevalence of non-communicable diseases (NCDs) and new premium priced medicines for cancer, orphan diseases and other complex areas. This is difficult to sustain without reforms. Methods: Extensive narrative review of published papers and contextualizing the findings to provide future guidance. Results: New models are being introduced to improve the managed entry of new medicines including managed entry agreements, fair pricing approaches and monitoring prescribing against agreed guidance. Multiple measures have also successfully been introduced to improve the prescribing of established medicines. This includes encouraging greater prescribing of generics and biosimilars versus originators and patented medicines in a class to conserve resources without compromising care. In addition, reducing inappropriate antibiotic utilization. Typically, multiple measures are the most effective. Conclusion: Multiple measures will be needed to attain and retain universal healthcare.

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“…However, as biologic batches are produced, providers and patients may be unaware of the heterogeneity and variation in the drugs they are prescribing or receiving. 7 The amount of variation caused by how patients handle and use biologics likely outweighs, by a massive degree, the minor heterogeneity and variation among different batches of an innovator as well as between an innovator and its biosimilar. Approximately 26 000 patients received innovator etanercept in clinical trials without any grossly detectable changes to the efficacy, tolerability and safety profiles from the introduction of etanercept through repeated manufacturing process changes.…”

Section: Editormentioning

confidence: 99%

Heterogeneity and variation of innovator biologics

Sahni

Feldman

2018

Acad Dermatol Venereol

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Degree of prescriber’s knowledge about variability in biological drugs “innovators” in manufacturing process

Abstract: BI present a high ARC during their MP after their commercialization, without any efficacy or safety difficulties. Knowledge of this might increase confidence for biosimilars.

Cited by 11 publications

References 18 publications

Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease

Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease

Evidence-based public policy making for medicines across countries: findings and implications for the future

Heterogeneity and variation of innovator biologics

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