RITUXIMAB BIOSIMILAR RTXM83 POST-MARKETING SURVEILLANCE IN BRAZIL: EVALUATION OF THE ADVERSE EVENTS SPONTANEOUSLY REPORTED TO PHARMACOVIGILANCE
Background: Biosimilars are highly similar to their reference products, but unlike generic drugs, they are not identical. Differences between a biosimilar and its reference product may arise because of the complexity of biologics, differences in the cell lines and processes used during manufacturing...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2021-10-01
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| Series: | Hematology, Transfusion and Cell Therapy |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2531137921003205 |
| _version_ | 1819013977964806144 |
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| author | AM Silva E Honda TTWO Watanabe ALMT Borsoi |
| author_facet | AM Silva E Honda TTWO Watanabe ALMT Borsoi |
| author_sort | AM Silva |
| collection | DOAJ |
| description | Background: Biosimilars are highly similar to their reference products, but unlike generic drugs, they are not identical. Differences between a biosimilar and its reference product may arise because of the complexity of biologics, differences in the cell lines and processes used during manufacturing. Biosimilars are approved in Europe, United States and Brazil through a regulatory pathway based on comparative analytical, clinical studies and demonstration of no clinically meaningful differences from their reference products. Post marketing pharmacovigilance is a useful tool to confirm the safety profile of biosimilar medication in the general population, outside of controlled environment of clinical studies. In 2019, rituximab biosimilar RTXM83 was approved in Brazil. Objective: The purpose of this communication is to present rituximab biosimilar RTXM83 information collected from adverse events (AEs) spontaneous reports during post-marketing pharmacovigilance activities in Brazil. Method: Descriptive retrospective study. Treatment related data and AEs from all spontaneous reports with biosimilar rituximab RTXM83 were reviewed. AEs were classified according to medical terminology (MedDRA) and seriousness assessed by the CTCAE (Common Toxicity Criteria) version 5.0 scale. Descriptive analysis of demographic data and AEs reported was performed. Results: A total of 32 reports containing 59 adverse events (AEs) were received from spontaneous reports between September 2019 and July 2021. From 32 reports, 19 were female, 12 were male and 1 not informed. The patients mean age was 48,8 (13 to 81years). The treatment indication was hematology oncology diseases in 23 (72%) patients, autoimmune disease in 7 patients (22%) and not informed in 2 (6%) patients. Regarding AEs seriousness and expectedness, 26 (44%) were non-serious AEs (24 expected / 2 unexpected) and 33 (56%) were serious AEs (22 expected / 11 unexpected). The five most frequently reported AEs according to SOC (System Organ Classification) were immune system disorders 19 (32%), blood and lymphatic system disorders 14 (24%), nervous system disorders 4 (7%), investigations 3 (5%), respiratory, thoracic and mediastinal disorders 3 (5%). The five most commonly reported adverse events (MedDRA PT - Preferred term) were infusion related reaction 18 (31%), neutropenia 6 (10%), anaemia 3 (5%), leukopenia 2 (3%), thrombocytopenia 2 (3%). Conclusion: AEs spontaneously reported in patients treated with biosimilar rituximab RTXM83 were consistent with the reference safety information based on literature data and the Summary of Product Characteristics (SmPC) of the reference product. No new safety signals were detected. |
| first_indexed | 2024-12-21T02:08:31Z |
| format | Article |
| id | doaj.art-5e31f9dfdc984c508c3f9d8bb7e55943 |
| institution | Directory Open Access Journal |
| issn | 2531-1379 |
| language | English |
| last_indexed | 2024-12-21T02:08:31Z |
| publishDate | 2021-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Hematology, Transfusion and Cell Therapy |
| spelling | doaj.art-5e31f9dfdc984c508c3f9d8bb7e559432022-12-21T19:19:25ZengElsevierHematology, Transfusion and Cell Therapy2531-13792021-10-0143S102RITUXIMAB BIOSIMILAR RTXM83 POST-MARKETING SURVEILLANCE IN BRAZIL: EVALUATION OF THE ADVERSE EVENTS SPONTANEOUSLY REPORTED TO PHARMACOVIGILANCEAM Silva0E Honda1TTWO Watanabe2ALMT Borsoi3Clínica São Peregrino, São Paulo, SP, BrazilLibbs Pharmaceuticals, São Paulo, SP, BrazilLibbs Pharmaceuticals, São Paulo, SP, BrazilLibbs Pharmaceuticals, São Paulo, SP, BrazilBackground: Biosimilars are highly similar to their reference products, but unlike generic drugs, they are not identical. Differences between a biosimilar and its reference product may arise because of the complexity of biologics, differences in the cell lines and processes used during manufacturing. Biosimilars are approved in Europe, United States and Brazil through a regulatory pathway based on comparative analytical, clinical studies and demonstration of no clinically meaningful differences from their reference products. Post marketing pharmacovigilance is a useful tool to confirm the safety profile of biosimilar medication in the general population, outside of controlled environment of clinical studies. In 2019, rituximab biosimilar RTXM83 was approved in Brazil. Objective: The purpose of this communication is to present rituximab biosimilar RTXM83 information collected from adverse events (AEs) spontaneous reports during post-marketing pharmacovigilance activities in Brazil. Method: Descriptive retrospective study. Treatment related data and AEs from all spontaneous reports with biosimilar rituximab RTXM83 were reviewed. AEs were classified according to medical terminology (MedDRA) and seriousness assessed by the CTCAE (Common Toxicity Criteria) version 5.0 scale. Descriptive analysis of demographic data and AEs reported was performed. Results: A total of 32 reports containing 59 adverse events (AEs) were received from spontaneous reports between September 2019 and July 2021. From 32 reports, 19 were female, 12 were male and 1 not informed. The patients mean age was 48,8 (13 to 81years). The treatment indication was hematology oncology diseases in 23 (72%) patients, autoimmune disease in 7 patients (22%) and not informed in 2 (6%) patients. Regarding AEs seriousness and expectedness, 26 (44%) were non-serious AEs (24 expected / 2 unexpected) and 33 (56%) were serious AEs (22 expected / 11 unexpected). The five most frequently reported AEs according to SOC (System Organ Classification) were immune system disorders 19 (32%), blood and lymphatic system disorders 14 (24%), nervous system disorders 4 (7%), investigations 3 (5%), respiratory, thoracic and mediastinal disorders 3 (5%). The five most commonly reported adverse events (MedDRA PT - Preferred term) were infusion related reaction 18 (31%), neutropenia 6 (10%), anaemia 3 (5%), leukopenia 2 (3%), thrombocytopenia 2 (3%). Conclusion: AEs spontaneously reported in patients treated with biosimilar rituximab RTXM83 were consistent with the reference safety information based on literature data and the Summary of Product Characteristics (SmPC) of the reference product. No new safety signals were detected.http://www.sciencedirect.com/science/article/pii/S2531137921003205 |
| spellingShingle | AM Silva E Honda TTWO Watanabe ALMT Borsoi RITUXIMAB BIOSIMILAR RTXM83 POST-MARKETING SURVEILLANCE IN BRAZIL: EVALUATION OF THE ADVERSE EVENTS SPONTANEOUSLY REPORTED TO PHARMACOVIGILANCE Hematology, Transfusion and Cell Therapy |
| title | RITUXIMAB BIOSIMILAR RTXM83 POST-MARKETING SURVEILLANCE IN BRAZIL: EVALUATION OF THE ADVERSE EVENTS SPONTANEOUSLY REPORTED TO PHARMACOVIGILANCE |
| title_full | RITUXIMAB BIOSIMILAR RTXM83 POST-MARKETING SURVEILLANCE IN BRAZIL: EVALUATION OF THE ADVERSE EVENTS SPONTANEOUSLY REPORTED TO PHARMACOVIGILANCE |
| title_fullStr | RITUXIMAB BIOSIMILAR RTXM83 POST-MARKETING SURVEILLANCE IN BRAZIL: EVALUATION OF THE ADVERSE EVENTS SPONTANEOUSLY REPORTED TO PHARMACOVIGILANCE |
| title_full_unstemmed | RITUXIMAB BIOSIMILAR RTXM83 POST-MARKETING SURVEILLANCE IN BRAZIL: EVALUATION OF THE ADVERSE EVENTS SPONTANEOUSLY REPORTED TO PHARMACOVIGILANCE |
| title_short | RITUXIMAB BIOSIMILAR RTXM83 POST-MARKETING SURVEILLANCE IN BRAZIL: EVALUATION OF THE ADVERSE EVENTS SPONTANEOUSLY REPORTED TO PHARMACOVIGILANCE |
| title_sort | rituximab biosimilar rtxm83 post marketing surveillance in brazil evaluation of the adverse events spontaneously reported to pharmacovigilance |
| url | http://www.sciencedirect.com/science/article/pii/S2531137921003205 |
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