Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial

Jørgensen, Kristin Kaasen; Olsen, I.C.; Goll, Guro Løvik; Lorentzen, M; Bolstad, Nils; Haavardsholm, Espen A.; Lundin, Knut E.A.; Mørk, Cato; Jahnsen, Jørgen; Kvien, Tore K; Berset, Ingrid Prytz; Fevang, Bjørg Ts; Florholmen, Jon; Kalstad, Synøve; Mørk, N J; Ryggen, Kristin; Tveit, Kåre Steinar; Sæther, Sigrun K; Gulbrandsen, Bjørn; Hagfors, Jon; Waksvik, Kenneth; Warren, David J.; Henanger, Karoline J.; Asak, Øivind; Baigh, Somyeh; Blomgren, Ingrid Marianne; Bruun, Trude Jannecke; Dvergsnes, Katrine; Frigstad, Svein Oskar; Gjesdal, Clara Gram; Grandaunet, Berit; Hansen, Inger Marie Jensen; Hatten, Ingvild S H; Huppertz-Hauss, Gert; Henriksen, Magne; Hoie, S. S.; Krogh, J.; Kruse, Julia R; Ljoså, Maud-Kristine A; Midtgard, I. P.; Mielnik, Paweł; Moum, Bjørn; Noraberg, Geir; Poyan, A.; Prestegård, Ulf; Rashid, Haroon; Rydning, Jan Henrik; Sagatun, Liv; Seeberg, Kathrine Aglen; Skjetne, Kristine; Strand, Eldri Kveine; Stray, Hilde; Stray, Njaal; Torp, Roald; Vold, Cecilia; Ystrøm, Carl Magnus; Zettel, Camilla

doi:10.1016/s0140-6736(17)30068-5

Cited by 703 publications

(677 citation statements)

References 25 publications

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“…Ultimately, regulatory authorities will assess the available evidence for each proposed bevacizumab biosimilar on a case-by-case basis and determine whether to authorize them for additional indications via extrapolation. Significant clinical experience to date with approved and licensed biosimilars has shown, as anticipated, that biosimilars behave similarly to the originator products, including in indications that were approved through the process of extrapolation [91], and has expanded patient access to needed biologic therapies [87].…”

Section: Resultsmentioning

confidence: 99%

Bevacizumab Biosimilars: Scientific Justification for Extrapolation of Indications

et al. 2018

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The first biosimilar of bevacizumab was approved by the US FDA; other potential biosimilars of bevacizumab are in late-stage clinical development. Their availability offers opportunity for increased patient access across a number of oncologic indications. The regulatory pathway for biosimilar approval relies on the totality of evidence that includes a comprehensive analytical assessment, and a clinical comparability study in a relevant disease patient population. Extrapolation of indications for a biosimilar to other eligible indications held by the originator, in the absence of direct clinical comparison, frequently forms part of the regulatory judgment. Herein, we consider the evidence required to demonstrate biosimilarity for bevacizumab biosimilars, with particular focus on the rationale for extrapolation across oncologic indications. Bevacizumab (Avastin R ; Roche, Welwyn Garden City, UK; Genentech, CA, USA) is a monoclonal antibody directed against VEGF. It is approved in Europe and the USA for the treatment of a range of cancers, including metastatic or recurrent nonsquamous non-small-cell lung cancer (NSCLC), metastatic renal cell carcinoma, metastatic colorectal cancer (CRC), cervical cancer, and platinum-resistant or platinum-sensitive recurrent epithelial ovarian, fallopian tube and primary peritoneal cancers [1,2]. In addition, in the USA, Japan, and many other countries, bevacizumab is indicated for the treatment of patients with glioblastoma. In Europe, it is also authorized for use in metastatic breast cancer and in combination with erlotinib for the first-line treatment of advanced, metastatic nonsquamous NSCLC with EGF receptor-activating mutations [3]. Randomized Phase III trials have shown that progression-free survival (PFS) and/or overall survival (OS) in patients with these cancers is prolonged with treatment combining bevacizumab with standard chemotherapy (Table 1) [4][5][6][7][8][9][10][11][12]. Nonetheless, patient access to bevacizumab may be limited.Barriers to bevacizumab use stem from factors such as insurance coverage and cost of treatment, manufacturing and supply and uncertainty as to its cost-effectiveness in some clinical settings [13][14][15]. A survey conducted by the European Society of Medical Oncology Consortium found budget constraints, affordability and issues related to the manufacture and assured supply of the product were cited most frequently as reasons for access to bevacizumab to be considered suboptimal [13]. Oncologists who were surveyed in the USA, Europe and in some emerging market countries (Brazil, Mexico and Turkey) stated the major barriers to prescribing bevacizumab were the high out-of-pocket costs for patients and a lack of reimbursement. These barriers were commonly cited as reasons for reducing the number of drug treatment cycles that were planned for patients [15].Protein-based biologics, such as bevacizumab, are produced in living cells rather than by chemical synthesis, and are large and structurally complex [16]. Their structure and activity are in...

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Section: Resultsmentioning

confidence: 99%

Bevacizumab Biosimilars: Scientific Justification for Extrapolation of Indications

et al. 2018

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“…In October 2016, explorative subgroup analyses of patients with CD and UC in the NOR-SWITCH study showed similarity between patients treated with originator infliximab and biosimilar infliximab CT-P13 with regard to efficacy, safety and immunogenicity [27]. Although this was one of the more large-scale controlled studies where biosimilar infliximab CT-P13 was tested in IBD patients, the small sample size of the IBD subgroup was too small to demonstrate any difference in ADR identification or minor differences in effect [27].…”

Section: Methodsmentioning

confidence: 99%

“…Although this was one of the more large-scale controlled studies where biosimilar infliximab CT-P13 was tested in IBD patients, the small sample size of the IBD subgroup was too small to demonstrate any difference in ADR identification or minor differences in effect [27]. However, it was still an advancement on previous evidence for switching which was more so justified on the concept of extrapolation.…”

Section: Methodsmentioning

confidence: 99%

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

O’Brien¹,

Carrol²,

Mulcahy³

et al. 2018

GaBI J

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“…Data on switching from the originator product to its biosimilar have been provided in the extension phases of comparative clinical studies and in the randomized NOR-SWITCH study, and have not identified any significant safety or efficacy concerns. 122,140–142 …”

Section: Biosimilars Relevant To Inflammatory Conditions: Global Scenmentioning

confidence: 99%

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Scheinberg

Pineda

Castañeda‐Hernández

et al. 2018

mAbs

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Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patient access to biologics. In Latin American countries, regulatory frameworks for biosimilar approval have been introduced in recent years, and biosimilars of monoclonal antibody and fusion protein therapies are now emerging. However, the situation in this region is complicated by the presence of “non-comparable biotherapeutics” (also known as “intended copies”), which have not been rigorously compared with the originator product. We review the considerations for clinicians in Latin American countries, focusing on monoclonal antibody biosimilars relevant to oncology, rheumatology, gastroenterology, and dermatology.

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Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial

Cited by 703 publications

References 25 publications

Bevacizumab Biosimilars: Scientific Justification for Extrapolation of Indications

Bevacizumab Biosimilars: Scientific Justification for Extrapolation of Indications

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

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