Scientific rationale for extrapolation of biosimilar data across cancer indications: case study of CT-P10

Kwon, Hyuk‐Chan; Yoon, Sang Wook

doi:10.2217/fon-2017-0156

Cited by 13 publications

(7 citation statements)

References 31 publications

(20 reference statements)

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“…Two rituximab biosimilars (rituximab-abbs [Truxima R ] and rituximab-pvvr [Ruxience R ]) received FDA approval for all the approved oncology indications of the rituximab reference medication, including those utilizing monotherapy and combination therapies [13,14]. Furthermore, the FDA approvals included indications not studied in comparative clinical trials of the biosimilar; rather, they are extrapolated with scientific justification, utilizing the totality of the evidence known about the reference medication and the biosimilar [2,15]. Due to the limited number of clinical trials being conducted, realworld evidence can potentially uncover knowledge gaps and provide insights on the acceptance and manner of use of rituximab biosimilars by key stakeholders, including physicians, pharmacists, and patients [16].…”

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confidence: 99%

Real-World Use and Acceptance of Biosimilar Monoclonal Antibodies of Rituximab in Oncology Practice in the USA

et al. 2021

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Aim: To describe treatment patterns and patient and provider characteristics associated with the recently introduced biosimilar rituximab-pvvr. Methods: This retrospective analysis included adult patients with one or more claims for rituximab-pvvr, with an index date of 23 January 2020 and a study period covering 1 January 2019–31 July 2020. Results: Of 249 patients included, the most common rituximab-pvvr indications were non-Hodgkin’s lymphoma (77.5%) and chronic lymphocytic leukemia (11.2%). Some patients with non-Hodgkin’s lymphoma (42.5%) and chronic lymphocytic leukemia (39.3%) switched to rituximab-pvvr from the reference product or another rituximab biosimilar. Most patients were aged ≥65 years (63.5%) and were male (54.6%). Most (59.0%) rituximab-pvvr prescribers practiced in the south of the USA. Conclusion: Utilization occurred in approved and extrapolated indications. These preliminary findings suggest switching between reference product and rituximab biosimilars; rituximab-pvvr combination regimens are being adopted in real-world oncology practice.

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confidence: 99%

Real-World Use and Acceptance of Biosimilar Monoclonal Antibodies of Rituximab in Oncology Practice in the USA

et al. 2021

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“…With regard to regulatory approval of a new biosimilar product, if it is considered to be highly similar to the originator medicine and has comparable safety and efficacy in one therapeutic indication, extrapolation of indications is often possible -as long as this can be scientifically justified [10,16]. In such a scenario, other indications of the originator may be granted to the biosimilar without needing to go through separate, large-scale clinical study programs, but most clinicians would not accept extrapolation to use a new product in clinical practice.…”

Section: Biosimilar Anti-tnf Agents In Psoriasis: Helping To Address Key Challengesmentioning

confidence: 99%

Anti-tumor necrosis factor agents in psoriasis: addressing key challenges using biosimilars

Prignano

Choi

Pieper

et al. 2020

Expert Opinion on Biological Therapy

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Introduction: Anti-tumor necrosis factor agents are key treatment options in moderate-severe psoriasis. The advent of multiple biosimilars of these drugs provides a major opportunity to address this particular factor by helping to reduce costs. Reduced cost can help improve undertreatment, which is one of the challenges in treating moderate-severe psoriasis. There is now a wealth of real-world evidence demonstrating that patients with psoriasis can be initiated on -or transitioned to -an anti-TNF biosimilar without detrimental effects on overall safety and efficacy. Furthermore, recent results suggest that patients can be switched between different biosimilar versions of the same anti-TNF agent without any compromise in outcomes. Areas covered: In this review, we summarized the role of anti-TNFs in psoriasis, health economic aspects of anti-TNF biosimilars, and their real-world data in clinical practice and registries. Expert opinion: The introduction and competition of anti-TNF biosimilars reduced the cost of biologics and accumulated real-world data support efficacy and safety of anti-TNF biosimilars for psoriasis treatment. Although IL-17 and IL-23 inhibitors show better efficacy in psoriasis patients, long-term efficacy and safety data of anti-TNF and cost-effectiveness of anti-TNF biosimilars may play an important role to increase patient access to biologics through greater adoption of biosimilars.

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“…The foundation of biosimilarity rests on the demonstration of similarity in structure and function. Analytical assessments are performed that compare the originator product and potential biosimilar, to confirm similarity in primary sequence, higher-order protein structure, post-translational modifications, biochemical quality [48].…”

Section: Demonstrating Biosimilaritymentioning

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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Scientific rationale for extrapolation of biosimilar data across cancer indications: case study of CT-P10

Cited by 13 publications

References 31 publications

Real-World Use and Acceptance of Biosimilar Monoclonal Antibodies of Rituximab in Oncology Practice in the USA

Real-World Use and Acceptance of Biosimilar Monoclonal Antibodies of Rituximab in Oncology Practice in the USA

Anti-tumor necrosis factor agents in psoriasis: addressing key challenges using biosimilars

Bevacizumab Biosimilars: Scientific Justification for Extrapolation of Indications

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