'Totality of Evidence' Approach in the Development of GP2017, an Approved Adalimumab Biosimilar
© 2024. The Author(s)..
INTRODUCTION: Hyrimoz®, (GP2017 [SDZ-ADL]), is a biosimilar to Humira® (REF-ADL). SDZ-ADL was approved in 2018 by both the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) for the indications of REF-ADL not protected by orphan exclusivity. In 2023, the US FDA and EMA also approved a citrate-free high-concentration formulation (HCF) of SDZ-ADL.
TOTALITY OF EVIDENCE-THE APPROACH: Approval of SDZ-ADL was based on data gathered using the US FDA, EMA and World Health Organization (WHO)-recommended step-wise Totality of Evidence approach. This approach is a robust dataset confirming high confidence in analytical, functional, pharmacokinetic (PK) and clinical biosimilarity between the biosimilar and reference medicine determined through analytical and clinical investigation.
EVIDENCE OF BIOSIMILARITY: Evidence supporting the biosimilarity of SDZ-ADL and REF-ADL was reported at each stage of investigation. Comprehensive comparative analytical and functional assessments demonstrated that SDZ-ADL was analytically indistinguishable from REF-ADL in required critical quality attributes, including receptor binding. Phase I clinical data showed PK similarity of SDZ-ADL and REF-ADL in healthy volunteers, with similar safety, tolerability and immunogenicity profiles. Phase III confirmatory efficacy and safety studies, ADACCESS (included in US/EU dossiers) and ADMYRA (separate to US/EU dossiers), both confirmed that SDZ-ADL's efficacy, safety, and immunogenicity matched REF-ADL in all patient groups with no clinically meaningful differences. More recently, this data package was the basis for a citrate-free HCF of SDZ-ADL to be developed, and its PK, safety and immunogenicity were confirmed against the initially approved formulation of SDZ-ADL.
CONCLUSION: Overall, the Totality of Evidence provided for biosimilar adalimumab, SDZ-ADL, confirmed the analytical, functional and clinical similarity of SDZ-ADL to REF-ADL, supporting its regulatory approval and providing a data bridge with which to evaluate and support the approval of citrate-free HCF SDZ-ADL for clinical use.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
|---|---|
| Enthalten in: |
Advances in therapy - 41(2024), 5 vom: 22. Apr., Seite 1795-1814 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Gaylis, Norman [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Adalimumab |
|---|
| Anmerkungen: |
Date Completed 26.04.2024 Date Revised 26.04.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1007/s12325-024-02809-w |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM370040813 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM370040813 | ||
| 003 | DE-627 | ||
| 005 | 20240427232152.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240323s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s12325-024-02809-w |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1390.xml |
| 035 | |a (DE-627)NLM370040813 | ||
| 035 | |a (NLM)38514505 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Gaylis, Norman |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 'Totality of Evidence' Approach in the Development of GP2017, an Approved Adalimumab Biosimilar |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 26.04.2024 | ||
| 500 | |a Date Revised 26.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a INTRODUCTION: Hyrimoz®, (GP2017 [SDZ-ADL]), is a biosimilar to Humira® (REF-ADL). SDZ-ADL was approved in 2018 by both the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) for the indications of REF-ADL not protected by orphan exclusivity. In 2023, the US FDA and EMA also approved a citrate-free high-concentration formulation (HCF) of SDZ-ADL | ||
| 520 | |a TOTALITY OF EVIDENCE-THE APPROACH: Approval of SDZ-ADL was based on data gathered using the US FDA, EMA and World Health Organization (WHO)-recommended step-wise Totality of Evidence approach. This approach is a robust dataset confirming high confidence in analytical, functional, pharmacokinetic (PK) and clinical biosimilarity between the biosimilar and reference medicine determined through analytical and clinical investigation | ||
| 520 | |a EVIDENCE OF BIOSIMILARITY: Evidence supporting the biosimilarity of SDZ-ADL and REF-ADL was reported at each stage of investigation. Comprehensive comparative analytical and functional assessments demonstrated that SDZ-ADL was analytically indistinguishable from REF-ADL in required critical quality attributes, including receptor binding. Phase I clinical data showed PK similarity of SDZ-ADL and REF-ADL in healthy volunteers, with similar safety, tolerability and immunogenicity profiles. Phase III confirmatory efficacy and safety studies, ADACCESS (included in US/EU dossiers) and ADMYRA (separate to US/EU dossiers), both confirmed that SDZ-ADL's efficacy, safety, and immunogenicity matched REF-ADL in all patient groups with no clinically meaningful differences. More recently, this data package was the basis for a citrate-free HCF of SDZ-ADL to be developed, and its PK, safety and immunogenicity were confirmed against the initially approved formulation of SDZ-ADL | ||
| 520 | |a CONCLUSION: Overall, the Totality of Evidence provided for biosimilar adalimumab, SDZ-ADL, confirmed the analytical, functional and clinical similarity of SDZ-ADL to REF-ADL, supporting its regulatory approval and providing a data bridge with which to evaluate and support the approval of citrate-free HCF SDZ-ADL for clinical use | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Review | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Adalimumab | |
| 650 | 4 | |a Biosimilar | |
| 650 | 4 | |a GP2017 | |
| 650 | 4 | |a Totality of Evidence | |
| 650 | 7 | |a Biosimilar Pharmaceuticals |2 NLM | |
| 650 | 7 | |a Adalimumab |2 NLM | |
| 650 | 7 | |a FYS6T7F842 |2 NLM | |
| 650 | 7 | |a GP2017 |2 NLM | |
| 650 | 7 | |a Antirheumatic Agents |2 NLM | |
| 700 | 1 | |a Both, Charlotte |e verfasserin |4 aut | |
| 700 | 1 | |a Lemke, Lena |e verfasserin |4 aut | |
| 700 | 1 | |a von Richter, Oliver |e verfasserin |4 aut | |
| 700 | 1 | |a Yamauchi, Paul |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Advances in therapy |d 1990 |g 41(2024), 5 vom: 22. Apr., Seite 1795-1814 |w (DE-627)NLM085859427 |x 1865-8652 |7 nnns |
| 773 | 1 | 8 | |g volume:41 |g year:2024 |g number:5 |g day:22 |g month:04 |g pages:1795-1814 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s12325-024-02809-w |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 41 |j 2024 |e 5 |b 22 |c 04 |h 1795-1814 | ||