Regulatory considerations in oncologic biosimilar drug development

Macdonald, Judith; Hartman, Helen B.; Jacobs, Ira

doi:10.1080/19420862.2015.1040973

Cited by 26 publications

(20 citation statements)

References 19 publications

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“…The ability to distinguish a biosimilar from the reference product, or from another biosimilar, has a bearing on accurately tracking the biological medicine 1. If there is clarity on naming, the product can be followed as it is switched from innovator to biosimilar, or even when many switches may be made such as between several biosimilars 2…”

Section: Considering the Biosimilar Namementioning

confidence: 99%

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Considering biosimilar policy

et al. 2017

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With the authorisation of an increasing number of biosimilars, and the prospect of multiple biosimilar switching, biosimilar naming and the importance of this for pharmacovigilance are coming into sharper focus. Current naming policies are not universal; neither are extrapolation criteria. Indeed, consideration of whether we can extrapolate information from one indication or disease to another continues to be a divisive topic. However, this is changing, as we strive for a more harmonised approach.Such a unified approach will be needed when considering future strategies to follow for multiple biosimilar switching, especially so because there is currently no uniform policy regarding interchangeability, switching, and automatic substitution. In this multiple biosimilar setting, the question as to whether we can be confident to move across indications will be increasingly important. The cost of biosimilar switching also needs to be considered—biosimilar use may mean that patients need more training and medical visits, with associated administrative costs.The biosimilars debate seems to be refocusing issues that have previously been extensively discussed but that have recently lost impetus, including the role of clinical pharmacology in internal medicine.

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Section: Considering the Biosimilar Namementioning

confidence: 99%

“…As for interchangeability, there are differences between regulatory agencies (figure 3). 1 38 39 In Europe, most member states did not allow automatic substitution of biological medicines,1 but this is changing quite rapidly 40 41…”

Section: Considering Interchangeability Switching and Automatic Submentioning

confidence: 99%

Considering biosimilar policy

et al. 2017

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“…1 Biosimilar proteins such as haematopoietic growth factors (e.g., erythropoietin, filgrastim) and monoclonal antibodies (mAbs) (e.g., infliximab) 2 are currently being used in clinical practice for the treatment of patients with cancer and immune-mediated disorders. In the next few years, a number of biologics will lose exclusivity, including trastuzumab, rituximab, cetuximab, bevacizumab and adalimumab.…”

Section: Introductionmentioning

confidence: 99%

“…Then, if differences are observed, further evaluation is required via a successive stepwise approach, including in vitro functionality comparisons and/or in vivo preclinical comparisons. 1 Next, comparative pharmacokinetic and pharmacodynamic studies are undertaken to detect potential differences in these parameters. The extensive analytical and non-clinical comparisons allow the clinical efficacy studies to be more tailored and targeted to addressing whether any existing differences are clinically meaningful.…”

Section: Introductionmentioning

confidence: 99%

“…The extensive analytical and non-clinical comparisons allow the clinical efficacy studies to be more tailored and targeted to addressing whether any existing differences are clinically meaningful. 1 Remsima (infliximab) is the world's first approved biosimilar mAb. 9 Extensive physicochemical characterization of Remsima in relation to Remicade, the reference product, was conducted to demonstrate the highly similar properties between the 2 molecules.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of originator and biosimilar therapeutic monoclonal antibodies using comprehensive two-dimensional liquid chromatography coupled with time-of-flight mass spectrometry

Sorensen

Harmes

Stoll

et al. 2016

mAbs

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As research, development, and manufacturing of biosimilar protein therapeutics proliferates, there is great interest in the continued development of a portfolio of complementary analytical methods that can be used to efficiently and effectively characterize biosimilar candidate materials relative to the respective reference (i.e., originator) molecule. Liquid phase separation techniques such as liquid chromatography and capillary electrophoresis are powerful tools that can provide both qualitative and quantitative information about similarities and differences between reference and biosimilar materials, especially when coupled with mass spectrometry. However, the inherent complexity of these protein materials challenges even the most modern one-dimensional (1D) separation methods. Two-dimensional (2D) separations present a number of potential advantages over 1D methods, including increased peak capacity, 2D peak patterns that can facilitate unknown identification, and improvement in the compatibility of some separation methods with mass spectrometry. In this study, we demonstrate the use of comprehensive 2D-LC separations involving cation-exchange (CEX) and reversed-phase (RP) separations in the first and second dimensions to compare 3 reference/biosimilar pairs of monoclonal antibodies (cetuximab, trastuzumab and infliximab) that cover a range of similarity/disimilarity in a middle-up approach. The second dimension RP separations are coupled to time-of-flight mass spectrometry, which enables direct identification of features in the chromatograms obtained from mAbs digested with the IdeS enzyme, or digestion with IdeS followed by reduction with dithiothreitol. As many as 23 chemically unique mAb fragments were detected in a single sample. Our results demonstrate that these rich datasets enable facile assesment of the degree of similarity between reference and biosimilar materials.

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Novel Therapies to Overcome HER2 Therapy Resistance in Breast Cancer

Nahta

2019

Resistance to Targeted Anti-Cancer Therapeutics

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Regulatory considerations in oncologic biosimilar drug development

Cited by 26 publications

References 19 publications

Considering biosimilar policy

Considering biosimilar policy

Comparison of originator and biosimilar therapeutic monoclonal antibodies using comprehensive two-dimensional liquid chromatography coupled with time-of-flight mass spectrometry

Novel Therapies to Overcome HER2 Therapy Resistance in Breast Cancer

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