Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases

Wojciech Jurczak; Stanley Cohen; Timothy M Illidge; Antonio da Silva; Jutta Amersdorffer

doi:10.2217/fon-2019-0430

Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases

Wojciech Jurczak, Stanley Cohen, Timothy M Illidge, Antonio da Silva, Jutta Amersdorffer

Division of Cancer Sciences (L5)

Research output: Contribution to journal › Review article › peer-review

Abstract

Sandoz rituximab (SDZ-RTX; Rixathon®; GP2013), a rituximab biosimilar, was approved in June 2017 in Europe in all indications of reference rituximab. The stepwise SDZ-RTX development program generated extensive physicochemical, structural, functional, and biological data demonstrating a match with reference rituximab on all clinically relevant attributes. A focused clinical development program followed, in two indications selected for sensitivity to detect potential differences versus reference rituximab: rheumatoid arthritis (pivotal pharmacokinetics and efficacy evaluation) and follicular lymphoma (pivotal efficacy/safety evaluation). These trials demonstrated highly similar pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity profiles. The totality of evidence for biosimilarity for SDZ-RTX, combined with knowledge that B-cell depletion is common to each approved indication, allowed SDZ-RTX approval for use in all indications of reference rituximab.

Original language	English
Pages (from-to)	4223-4234
Number of pages	12
Journal	Future oncology (London, England)
Volume	15
Issue number	36
Early online date	13 Nov 2019
DOIs	https://doi.org/10.2217/fon-2019-0430
Publication status	Published - Dec 2019

Research Beacons, Institutes and Platforms

Manchester Cancer Research Centre

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.2217/fon-2019-0430Licence: CC BY-NC-ND

Cite this

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title = "Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases",

abstract = "Sandoz rituximab (SDZ-RTX; Rixathon{\textregistered}; GP2013), a rituximab biosimilar, was approved in June 2017 in Europe in all indications of reference rituximab. The stepwise SDZ-RTX development program generated extensive physicochemical, structural, functional, and biological data demonstrating a match with reference rituximab on all clinically relevant attributes. A focused clinical development program followed, in two indications selected for sensitivity to detect potential differences versus reference rituximab: rheumatoid arthritis (pivotal pharmacokinetics and efficacy evaluation) and follicular lymphoma (pivotal efficacy/safety evaluation). These trials demonstrated highly similar pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity profiles. The totality of evidence for biosimilarity for SDZ-RTX, combined with knowledge that B-cell depletion is common to each approved indication, allowed SDZ-RTX approval for use in all indications of reference rituximab.",

author = "Wojciech Jurczak and Stanley Cohen and Illidge, {Timothy M} and Silva, {Antonio da} and Jutta Amersdorffer",

year = "2019",

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doi = "10.2217/fon-2019-0430",

language = "English",

volume = "15",

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journal = "Future oncology (London, England)",

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T1 - Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases

AU - Jurczak, Wojciech

AU - Cohen, Stanley

AU - Illidge, Timothy M

AU - Silva, Antonio da

AU - Amersdorffer, Jutta

PY - 2019/12

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N2 - Sandoz rituximab (SDZ-RTX; Rixathon®; GP2013), a rituximab biosimilar, was approved in June 2017 in Europe in all indications of reference rituximab. The stepwise SDZ-RTX development program generated extensive physicochemical, structural, functional, and biological data demonstrating a match with reference rituximab on all clinically relevant attributes. A focused clinical development program followed, in two indications selected for sensitivity to detect potential differences versus reference rituximab: rheumatoid arthritis (pivotal pharmacokinetics and efficacy evaluation) and follicular lymphoma (pivotal efficacy/safety evaluation). These trials demonstrated highly similar pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity profiles. The totality of evidence for biosimilarity for SDZ-RTX, combined with knowledge that B-cell depletion is common to each approved indication, allowed SDZ-RTX approval for use in all indications of reference rituximab.

AB - Sandoz rituximab (SDZ-RTX; Rixathon®; GP2013), a rituximab biosimilar, was approved in June 2017 in Europe in all indications of reference rituximab. The stepwise SDZ-RTX development program generated extensive physicochemical, structural, functional, and biological data demonstrating a match with reference rituximab on all clinically relevant attributes. A focused clinical development program followed, in two indications selected for sensitivity to detect potential differences versus reference rituximab: rheumatoid arthritis (pivotal pharmacokinetics and efficacy evaluation) and follicular lymphoma (pivotal efficacy/safety evaluation). These trials demonstrated highly similar pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity profiles. The totality of evidence for biosimilarity for SDZ-RTX, combined with knowledge that B-cell depletion is common to each approved indication, allowed SDZ-RTX approval for use in all indications of reference rituximab.

U2 - 10.2217/fon-2019-0430

DO - 10.2217/fon-2019-0430

M3 - Review article

C2 - 31718287

SN - 1479-6694

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JO - Future oncology (London, England)

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