Biological therapy: chronicling 15 years of progress

Lewiecki, E. Michael

doi:10.1517/14712598.2015.1009890

Cited by 4 publications

(2 citation statements)

References 10 publications

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“…Biological therapies include, amongst others, vaccines, blood and blood components, and gene therapy . In the UK, the term biologics is now synonymous with monoclonal antibodies (mAbs) used to target specific pathological processes in a wide range of diseases .…”

Section: Introductionmentioning

confidence: 99%

A novel approach to support implementation of biosimilars within a UK tertiary hospital

Saxby

Sanghvi

Bodalia

et al. 2019

Brit J Clinical Pharma

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AimsTo assess the transfer of patients treated with originator biological therapies to biosimilar products in a large UK tertiary referral hospital reflecting practice within the National Health Service (NHS) using prospectively collected data by a hospital-based registry administered by the Biologics Steering Group (BSG). Methods:We analysed data collected prospectively in a hospital-based registry in a large NHS tertiary referral hospital in the UK. The registry was administered by the hospital's BSG, which considered requests for patients to remain on or revert to originator products. The registry contained prospectively collected data on patients switching therapy from an originator to a biosimilar. The data included clinical circumstances or rationale for each request, whether it was granted, and the results of clinical reviews at 3-6 months. Results: In a 12-month period, we identified 1299 patients who could switch to the respective biosimilar and, of these, 1196 (92%) did so. Of the 260 patients taking infliximab, 250 (96%) switched to infliximab biosimilar; of the 390 patients taking etanercept 50 mg, 298 (76%) switched to etanercept 50 mg biosimilar; and of the 649 patients taking rituximab, 648 (99%) switched to rituximab biosimilar. The BSG received 39 applications: 12 (out of 39) applications were to remain on the originator and 27 (out of 39) were to switch back to the originator. Of the applications to remain on the originator 10 (out of 12) were approved. At 3-6 month review, 2 of these approvals reported continued efficacy, 3 switched to the biosimilar, 3 switched to an alternative therapy and 2 stopped treatment. Two (out of 10) applications were not approved, both applicants reported efficacy with the biosimilar at follow up. Of the 27 applications to switch back to the originator, 16 (out of 27) applications were approved. At 3-6 months, 9 (out of 16) applicants reported regain of efficacy, 6 (out of 16) reported cessation of reported adverse effects and 1 (out of 16) switched to alternative therapy. Eight (out of 27) applications were not approved, and, at point of follow up, 50% reported efficacy with the biosimilar and 50% had switched to an alternative therapy. Three (out of 27) applications were withdrawn by the clinical team as efficacy was achieved with the biosimilar. Both authors contributed equally to the work

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Section: Introductionmentioning

confidence: 99%

A novel approach to support implementation of biosimilars within a UK tertiary hospital

Saxby

Sanghvi

Bodalia

et al. 2019

Brit J Clinical Pharma

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“…Not without its antecedents, as blood serum therapy and Bacillus Calmette-Guerin-boosting treatments to increase immune response were attempted in NSCLC long ago, they had little if any effect. 11 The umbrella-like terminology referencing biologic therapy encapsulates both immunotherapy and targeting therapy. Diagnostic monoclonal tumor antibodies common to the 1970s entered their adulthood as potential pharmaceuticals in the late 1990s and became applicable against advanced NSCLC by the middle of the first decade of 2000s.…”

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confidence: 99%