A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®)

Soohyun Kim, 1, 2,* Siun Kim, 1, 2,* Howard Lee 1– 4 1Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 2Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea; 4Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea*These authors contributed equally to this workCorrespondence: Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-Ro, Jongno-Gu, Seoul 110-799, KoreaTel +82 2-740-7602Fax +82 31-888-9575Email howardleesnu.ac.krAbstract: We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.Keywords: biosimilar, equivalence margin, rheumatoid arthritis, infliximab, CT-P13 Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Kim S [verfasserIn] Lee H [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2020

Schlagwörter:	biosimilar equivalence margin rheumatoid arthritis infliximab ct-p13

Übergeordnetes Werk:	In: Drug Design, Development and Therapy - Dove Medical Press, 2008, (2020), Seite 2831-2840
Übergeordnetes Werk:	year:2020 ; pages:2831-2840

Links:	Link aufrufen Link aufrufen Journal toc

Katalog-ID:	DOAJ037549006

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520			\|a Soohyun Kim, 1, 2,* Siun Kim, 1, 2,* Howard Lee 1– 4 1Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 2Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea; 4Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea*These authors contributed equally to this workCorrespondence: Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-Ro, Jongno-Gu, Seoul 110-799, KoreaTel +82 2-740-7602Fax +82 31-888-9575Email howardleesnu.ac.krAbstract: We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.Keywords: biosimilar, equivalence margin, rheumatoid arthritis, infliximab, CT-P13
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allfields	(DE-627)DOAJ037549006 (DE-599)DOAJ05ae623b0bc5481bb32e4df3d0cb0b0b DE-627 ger DE-627 rakwb eng RM1-950 Kim S verfasserin aut A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®) 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Soohyun Kim, 1, 2,* Siun Kim, 1, 2,* Howard Lee 1– 4 1Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 2Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea; 4Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea*These authors contributed equally to this workCorrespondence: Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-Ro, Jongno-Gu, Seoul 110-799, KoreaTel +82 2-740-7602Fax +82 31-888-9575Email howardleesnu.ac.krAbstract: We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.Keywords: biosimilar, equivalence margin, rheumatoid arthritis, infliximab, CT-P13 biosimilar equivalence margin rheumatoid arthritis infliximab ct-p13 Therapeutics. Pharmacology Kim S verfasserin aut Lee H verfasserin aut In Drug Design, Development and Therapy Dove Medical Press, 2008 (2020), Seite 2831-2840 (DE-627)578533138 (DE-600)2451346-5 11778881 nnns year:2020 pages:2831-2840 https://doaj.org/article/05ae623b0bc5481bb32e4df3d0cb0b0b kostenfrei https://www.dovepress.com/a-critical-review-of-the-united-states-regulatory-pathways-for-determi-peer-reviewed-article-DDDT kostenfrei https://doaj.org/toc/1177-8881 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2020 2831-2840
spelling	(DE-627)DOAJ037549006 (DE-599)DOAJ05ae623b0bc5481bb32e4df3d0cb0b0b DE-627 ger DE-627 rakwb eng RM1-950 Kim S verfasserin aut A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®) 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Soohyun Kim, 1, 2,* Siun Kim, 1, 2,* Howard Lee 1– 4 1Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 2Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea; 4Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea*These authors contributed equally to this workCorrespondence: Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-Ro, Jongno-Gu, Seoul 110-799, KoreaTel +82 2-740-7602Fax +82 31-888-9575Email howardleesnu.ac.krAbstract: We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.Keywords: biosimilar, equivalence margin, rheumatoid arthritis, infliximab, CT-P13 biosimilar equivalence margin rheumatoid arthritis infliximab ct-p13 Therapeutics. Pharmacology Kim S verfasserin aut Lee H verfasserin aut In Drug Design, Development and Therapy Dove Medical Press, 2008 (2020), Seite 2831-2840 (DE-627)578533138 (DE-600)2451346-5 11778881 nnns year:2020 pages:2831-2840 https://doaj.org/article/05ae623b0bc5481bb32e4df3d0cb0b0b kostenfrei https://www.dovepress.com/a-critical-review-of-the-united-states-regulatory-pathways-for-determi-peer-reviewed-article-DDDT kostenfrei https://doaj.org/toc/1177-8881 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2020 2831-2840
allfields_unstemmed	(DE-627)DOAJ037549006 (DE-599)DOAJ05ae623b0bc5481bb32e4df3d0cb0b0b DE-627 ger DE-627 rakwb eng RM1-950 Kim S verfasserin aut A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®) 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Soohyun Kim, 1, 2,* Siun Kim, 1, 2,* Howard Lee 1– 4 1Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 2Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea; 4Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea*These authors contributed equally to this workCorrespondence: Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-Ro, Jongno-Gu, Seoul 110-799, KoreaTel +82 2-740-7602Fax +82 31-888-9575Email howardleesnu.ac.krAbstract: We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.Keywords: biosimilar, equivalence margin, rheumatoid arthritis, infliximab, CT-P13 biosimilar equivalence margin rheumatoid arthritis infliximab ct-p13 Therapeutics. Pharmacology Kim S verfasserin aut Lee H verfasserin aut In Drug Design, Development and Therapy Dove Medical Press, 2008 (2020), Seite 2831-2840 (DE-627)578533138 (DE-600)2451346-5 11778881 nnns year:2020 pages:2831-2840 https://doaj.org/article/05ae623b0bc5481bb32e4df3d0cb0b0b kostenfrei https://www.dovepress.com/a-critical-review-of-the-united-states-regulatory-pathways-for-determi-peer-reviewed-article-DDDT kostenfrei https://doaj.org/toc/1177-8881 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2020 2831-2840
allfieldsGer	(DE-627)DOAJ037549006 (DE-599)DOAJ05ae623b0bc5481bb32e4df3d0cb0b0b DE-627 ger DE-627 rakwb eng RM1-950 Kim S verfasserin aut A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®) 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Soohyun Kim, 1, 2,* Siun Kim, 1, 2,* Howard Lee 1– 4 1Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 2Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea; 4Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea*These authors contributed equally to this workCorrespondence: Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-Ro, Jongno-Gu, Seoul 110-799, KoreaTel +82 2-740-7602Fax +82 31-888-9575Email howardleesnu.ac.krAbstract: We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.Keywords: biosimilar, equivalence margin, rheumatoid arthritis, infliximab, CT-P13 biosimilar equivalence margin rheumatoid arthritis infliximab ct-p13 Therapeutics. Pharmacology Kim S verfasserin aut Lee H verfasserin aut In Drug Design, Development and Therapy Dove Medical Press, 2008 (2020), Seite 2831-2840 (DE-627)578533138 (DE-600)2451346-5 11778881 nnns year:2020 pages:2831-2840 https://doaj.org/article/05ae623b0bc5481bb32e4df3d0cb0b0b kostenfrei https://www.dovepress.com/a-critical-review-of-the-united-states-regulatory-pathways-for-determi-peer-reviewed-article-DDDT kostenfrei https://doaj.org/toc/1177-8881 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2020 2831-2840
allfieldsSound	(DE-627)DOAJ037549006 (DE-599)DOAJ05ae623b0bc5481bb32e4df3d0cb0b0b DE-627 ger DE-627 rakwb eng RM1-950 Kim S verfasserin aut A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®) 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Soohyun Kim, 1, 2,* Siun Kim, 1, 2,* Howard Lee 1– 4 1Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 2Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea; 4Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea*These authors contributed equally to this workCorrespondence: Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-Ro, Jongno-Gu, Seoul 110-799, KoreaTel +82 2-740-7602Fax +82 31-888-9575Email howardleesnu.ac.krAbstract: We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.Keywords: biosimilar, equivalence margin, rheumatoid arthritis, infliximab, CT-P13 biosimilar equivalence margin rheumatoid arthritis infliximab ct-p13 Therapeutics. Pharmacology Kim S verfasserin aut Lee H verfasserin aut In Drug Design, Development and Therapy Dove Medical Press, 2008 (2020), Seite 2831-2840 (DE-627)578533138 (DE-600)2451346-5 11778881 nnns year:2020 pages:2831-2840 https://doaj.org/article/05ae623b0bc5481bb32e4df3d0cb0b0b kostenfrei https://www.dovepress.com/a-critical-review-of-the-united-states-regulatory-pathways-for-determi-peer-reviewed-article-DDDT kostenfrei https://doaj.org/toc/1177-8881 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2020 2831-2840
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title_sort	critical review of the united states regulatory pathways for determining the equivalence of efficacy between ct-p13 and original infliximab (remicade®)
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title_auth	A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®)
abstract	Soohyun Kim, 1, 2,* Siun Kim, 1, 2,* Howard Lee 1– 4 1Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 2Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea; 4Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea*These authors contributed equally to this workCorrespondence: Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-Ro, Jongno-Gu, Seoul 110-799, KoreaTel +82 2-740-7602Fax +82 31-888-9575Email howardleesnu.ac.krAbstract: We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.Keywords: biosimilar, equivalence margin, rheumatoid arthritis, infliximab, CT-P13
abstractGer	Soohyun Kim, 1, 2,* Siun Kim, 1, 2,* Howard Lee 1– 4 1Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 2Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea; 4Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea*These authors contributed equally to this workCorrespondence: Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-Ro, Jongno-Gu, Seoul 110-799, KoreaTel +82 2-740-7602Fax +82 31-888-9575Email howardleesnu.ac.krAbstract: We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.Keywords: biosimilar, equivalence margin, rheumatoid arthritis, infliximab, CT-P13
abstract_unstemmed	Soohyun Kim, 1, 2,* Siun Kim, 1, 2,* Howard Lee 1– 4 1Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 2Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea; 3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea; 4Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea*These authors contributed equally to this workCorrespondence: Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-Ro, Jongno-Gu, Seoul 110-799, KoreaTel +82 2-740-7602Fax +82 31-888-9575Email howardleesnu.ac.krAbstract: We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95– 95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled. A sensitivity analysis was performed for each study-pooling scenario. As a result, we identified two historical clinical trials that were deemed appropriate, whereas the PLANETRA trial pooled three additional studies to determine an equivalence margin, which was accepted by the United States Food and Drug Administration. However, those extra clinical trials did not meet the constancy assumption in baseline characteristics, methotrexate dose, and efficacy assessment time. The clinically more appropriate equivalence margin was 5.7 percentage points, which was much narrower than the 12 percentage points applied in the approval of CT-P13. In conclusion, the equivalence claim for CT-P13 to original infliximab in patients with rheumatoid arthritis did not appear to be supported when the constancy assumption was strictly assessed. The equivalence margin for biosimilars could be determined more conservatively.Keywords: biosimilar, equivalence margin, rheumatoid arthritis, infliximab, CT-P13
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title_short	A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®)
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A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade&reg;)

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A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®)