open access

Vol 48, No 4 (2017)
Prace poglądowe / Reviews
Published online: 2017-10-01
Submitted: 2017-10-11
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Rituximab – the first biosimilar monoclonal antibodies in hematooncology

Krzysztof Giannopoulos1, Tomasz Wróbel2, Wojciech Jurczak3, Sebastian Giebel4, Iwona Hus5, Wiesław Wiktor Jędrzejczak6, Tadeusz Robak7
DOI: 10.1016/j.achaem.2017.10.003
·
Acta Haematol Pol 2017;48(4):269-273.
Affiliations
  1. Zakład Hematoonkologii Doświadczalnej, Uniwersytet Medyczny w Lublinie; Oddział Hematologiczny Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli w Lublinie, Polska
  2. Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Uniwersytet Medyczny im. Piastów Śląskich we Wrocławiu, Polska
  3. Katedra i Klinika Hematologii Uniwersytet Jagielloński, Collegium Medicum w Krakowie, Polska
  4. Klinika Transplantacji Szpiku i Onkohematologii Centrum Onkologii – Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach, Polska
  5. Samodzielna Pracownia Transplantologii Klinicznej Uniwersytet Medyczny w Lublinie, Polska
  6. Katedra i Klinika Hematologii, Onkologii i Chorób Wewnętrznych, Warszawski Uniwersytet Medyczny, Polska
  7. Katedra i Klinika Hematologii, Uniwersytet Medyczny w Łodzi, Polska

open access

Vol 48, No 4 (2017)
Prace poglądowe / Reviews
Published online: 2017-10-01
Submitted: 2017-10-11

Abstract

The introduction of biosimilars can increase the availability of effective and life-saving therapies, while reducing their costs. Biosimilar and reference biological drugs are functionally the same molecules, identical in quality, biological activity, safety profile, immunogenicity and therapeutic efficacy. Recently, two pivotal registration studies for rituximab biosimilars have been summarized. In patients with follicular lymphoma (FL), the efficacy and safety of rituximab GP2013 was assessed in ASSIST-FL phase III clinical trial. At median follow-up of 11.6 months, the primary endpoint was achieved, in the GP2013 group overall response was 87% (271/311 patients) and 88% (274 /313 patients) in the reference arm). The incidence of adverse events and severe toxicities was similar in both groups. In the second study of 140 patients with FL, the overall response was 97.0% (64 of the 66 patients) in the CT-P10 group and 92.6% (63 of the 68 patients) in the group treated with rituximab. Treatment-emergent adverse events were reported for 83% (58 of 70 patients) in the CT-P10 treatment group and 80% (56 of 70) in the reference rituximab treatment group. Results of these studies indicate similar activity and toxicity profile of GP2013 and CT-P10 to the original rituximab.

Abstract

The introduction of biosimilars can increase the availability of effective and life-saving therapies, while reducing their costs. Biosimilar and reference biological drugs are functionally the same molecules, identical in quality, biological activity, safety profile, immunogenicity and therapeutic efficacy. Recently, two pivotal registration studies for rituximab biosimilars have been summarized. In patients with follicular lymphoma (FL), the efficacy and safety of rituximab GP2013 was assessed in ASSIST-FL phase III clinical trial. At median follow-up of 11.6 months, the primary endpoint was achieved, in the GP2013 group overall response was 87% (271/311 patients) and 88% (274 /313 patients) in the reference arm). The incidence of adverse events and severe toxicities was similar in both groups. In the second study of 140 patients with FL, the overall response was 97.0% (64 of the 66 patients) in the CT-P10 group and 92.6% (63 of the 68 patients) in the group treated with rituximab. Treatment-emergent adverse events were reported for 83% (58 of 70 patients) in the CT-P10 treatment group and 80% (56 of 70) in the reference rituximab treatment group. Results of these studies indicate similar activity and toxicity profile of GP2013 and CT-P10 to the original rituximab.

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Keywords

Rituximab; Monoclonal antibodies; Biosimilars; Extrapolation; ASSIST-FL; GP2013; CT-P10

About this article
Title

Rituximab – the first biosimilar monoclonal antibodies in hematooncology

Journal

Acta Haematologica Polonica

Issue

Vol 48, No 4 (2017)

Pages

269-273

Published online

2017-10-01

DOI

10.1016/j.achaem.2017.10.003

Bibliographic record

Acta Haematol Pol 2017;48(4):269-273.

Keywords

Rituximab
Monoclonal antibodies
Biosimilars
Extrapolation
ASSIST-FL
GP2013
CT-P10

Authors

Krzysztof Giannopoulos
Tomasz Wróbel
Wojciech Jurczak
Sebastian Giebel
Iwona Hus
Wiesław Wiktor Jędrzejczak
Tadeusz Robak

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