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SAFETY OF RITUXIMAB BIOSIMILAR (NOVEX®) IN THE ROUTINE USE TREATMENT IN ARGENTINA.
Author(s):
Gustavo Milone
,
Gustavo Milone
Affiliations:
Hematología,Centro Médico Hematológico,Buenos Aires,Argentina
María Ines Penna
,
María Ines Penna
Affiliations:
Laboratorio Elea,Buenos Aires,Argentina
Francisco Fernandez
,
Francisco Fernandez
Affiliations:
Laboratorio Elea,Buenos Aires,Argentina
Eduardo Spitzer
,
Eduardo Spitzer
Affiliations:
Laboratorio Elea,Buenos Aires,Argentina
Susana Millan
,
Susana Millan
Affiliations:
Mabxience,Madrid,Spain
Simona Mariani
,
Simona Mariani
Affiliations:
Mabxience,Madrid,Spain
Nadia Español
,
Nadia Español
Affiliations:
Mabxience,Madrid,Spain
Roberto Gomez
Roberto Gomez
Affiliations:
Laboratorio ELEA,Buenos Aires,Argentina
(Abstract release date: 05/18/17) EHA Library. Milone G. 05/18/17; 182846; PB2133
Gustavo Milone
Gustavo Milone
Contributions
PDF Abstract
Abstract

Abstract: PB2133

Type: Publication Only

Background
Novex® is a biosimilar by design of the reference product Mabthera®/Rituxan®. Novex® was approved in Argentina following ANMAT’s Biosimilar guidelines, having the same indications as the reference product, and is commercialized by Laboratorio Elea. As part of its Risk Management Plan (RMP), Laboratorio Elea implements an active pharmacovigilance program as defined in Argentina regulation. Periodically reports ANMAT RMP status and results.

Aims

To describe frequency and pattern of adverse events during the use of NOVEX® in treatments registered along an active pharmacovigilance program in order to oversee the safety profile of NOVEX® in the real clinical practice and maintain the benefit-risk evaluation.

Methods
A treatment Registry for NOVEX® was implemented from the beginning of NOVEX® commercialization as part of the RMP. The Data Lock Point for this report is Jan 31st, 2017. Physicians prescribing NOVEX® were requested to fill a form indicating age and gender, treatment start date, treated pathology, dosing and dose frequency. Such data was recorded in a database. After a preset time, physicians were contacted by Laboratorio Elea to ask them about the treatment outcome and Adverse Event occurrences. If adverse events were detected they reported each occurrence as Individual Case Safety Report (ICSR), they were registered using the MedDRA dictionary (version 19.1) for its codification.

Results

The total number of participating physicians was 151. During this period, they reported 638 treatment initiations, 389 of which had at least 1 follow up point and were included in further analysis. 53% male. Mean age 64.1 years. Hematological indications were more than 90%. More than 90% of indications were approved indications. Nevertheless, we detected off-label use.
Total cycles received for any approved indication had a mean number of 5.7.
Total received Individual Case Safety Reports were 17, indicating a relative frequency of 4.4% of Individual Case Safety Report. Occurrence rates were 1.2 Individual Case Safety Report per 100 administered cycles, and 0.020 per 100 treatment days. Eleven Individual Case Safety Reports were classified as serious (SAE) because they had at least one manifestation that prolonged hospitalization, endangered life or was death-associated.
The most frequent AE reported was acute reaction related to infusion (9 cases), followed by cardiovascular manifestations (2 arrhythmia, 1 cardiac failure and 1 ischemic stroke), infections (1 pneumonia, 1 progressive multifocal leukoencephalopathy), neurologic (1 paresthesia), cytopenias (1 pancytopenia) and cutaneous (1 bullous dermatitis).

Conclusion

The activities developed under this active pharmacovigilance program showed great value allowing us not only to monitor the adverse event pattern but also to detect off-label use as part of real life treatments.
This report showed a similar safety profile to that of the reference product concluding that NOVEX®, in terms of tolerability, is similar to the reference product.
Pharmacovigilance is cornerstone in the development of biologicals, especially biosimilars, as a tool to assist in the knowledge about their safety profile.

Session topic: 35. Quality of life, palliative care, ethics and health economics

Keyword(s): Rituximab, Monoclonal antibody, Antibody response, Adverse reaction

Abstract: PB2133

Type: Publication Only

Background
Novex® is a biosimilar by design of the reference product Mabthera®/Rituxan®. Novex® was approved in Argentina following ANMAT’s Biosimilar guidelines, having the same indications as the reference product, and is commercialized by Laboratorio Elea. As part of its Risk Management Plan (RMP), Laboratorio Elea implements an active pharmacovigilance program as defined in Argentina regulation. Periodically reports ANMAT RMP status and results.

Aims

To describe frequency and pattern of adverse events during the use of NOVEX® in treatments registered along an active pharmacovigilance program in order to oversee the safety profile of NOVEX® in the real clinical practice and maintain the benefit-risk evaluation.

Methods
A treatment Registry for NOVEX® was implemented from the beginning of NOVEX® commercialization as part of the RMP. The Data Lock Point for this report is Jan 31st, 2017. Physicians prescribing NOVEX® were requested to fill a form indicating age and gender, treatment start date, treated pathology, dosing and dose frequency. Such data was recorded in a database. After a preset time, physicians were contacted by Laboratorio Elea to ask them about the treatment outcome and Adverse Event occurrences. If adverse events were detected they reported each occurrence as Individual Case Safety Report (ICSR), they were registered using the MedDRA dictionary (version 19.1) for its codification.

Results

The total number of participating physicians was 151. During this period, they reported 638 treatment initiations, 389 of which had at least 1 follow up point and were included in further analysis. 53% male. Mean age 64.1 years. Hematological indications were more than 90%. More than 90% of indications were approved indications. Nevertheless, we detected off-label use.
Total cycles received for any approved indication had a mean number of 5.7.
Total received Individual Case Safety Reports were 17, indicating a relative frequency of 4.4% of Individual Case Safety Report. Occurrence rates were 1.2 Individual Case Safety Report per 100 administered cycles, and 0.020 per 100 treatment days. Eleven Individual Case Safety Reports were classified as serious (SAE) because they had at least one manifestation that prolonged hospitalization, endangered life or was death-associated.
The most frequent AE reported was acute reaction related to infusion (9 cases), followed by cardiovascular manifestations (2 arrhythmia, 1 cardiac failure and 1 ischemic stroke), infections (1 pneumonia, 1 progressive multifocal leukoencephalopathy), neurologic (1 paresthesia), cytopenias (1 pancytopenia) and cutaneous (1 bullous dermatitis).

Conclusion

The activities developed under this active pharmacovigilance program showed great value allowing us not only to monitor the adverse event pattern but also to detect off-label use as part of real life treatments.
This report showed a similar safety profile to that of the reference product concluding that NOVEX®, in terms of tolerability, is similar to the reference product.
Pharmacovigilance is cornerstone in the development of biologicals, especially biosimilars, as a tool to assist in the knowledge about their safety profile.

Session topic: 35. Quality of life, palliative care, ethics and health economics

Keyword(s): Rituximab, Monoclonal antibody, Antibody response, Adverse reaction

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