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IV treatment with IGSC, 10% — Competitive Intelligence Brief
phase 3
Immunoglobulin replacement therapy
Fc receptors, complement system, pathogenic antigens
Immunology
Biologic
Live · refreshed every 30 min
Target snapshot
IV treatment with IGSC, 10% (IV treatment with IGSC, 10%) — Baxalta now part of Shire. IGSC 10% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to help regulate immune function and fight infections.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| IV treatment with IGSC, 10% TARGET | IV treatment with IGSC, 10% | Baxalta now part of Shire | phase 3 | Immunoglobulin replacement therapy | Fc receptors, complement system, pathogenic antigens | |
| PRIVIGEN (CSL Behring) | PRIVIGEN (CSL Behring) | Hospices Civils de Lyon | marketed | Intravenous immunoglobulin (IVIg) | Fc receptors, complement system, pathogenic antigens and antibodies | |
| IGIV GAMMAGARD LIQUID/KIOVIG | IGIV GAMMAGARD LIQUID/KIOVIG | Baxalta now part of Shire | phase 3 | Intravenous immunoglobulin (IGIV) | Fc receptors, complement system, pathogenic antigens | |
| IGIV3I Grifols | IGIV3I Grifols | Instituto Grifols, S.A. | phase 3 | Intravenous immunoglobulin (IVIG) | Fc receptors, complement system, pathogenic antigens | |
| LIV-GAMMA SN Inj.10% | LIV-GAMMA SN Inj.10% | SK Plasma Co., Ltd. | phase 3 | Intravenous immunoglobulin (IVIG) | Fc receptors, complement system, pathogenic antigens | |
| IgNextGen 16% | IgNextGen 16% | CSL Limited | phase 3 | Intravenous immunoglobulin (IVIG) | Fc receptors, complement system, pathogenic antigens | |
| Gamunex Intravenous Immunoglobulin | Gamunex Intravenous Immunoglobulin | National Institute of Mental Health (NIMH) | phase 3 | Intravenous Immunoglobulin (IVIG) | Fc receptors, complement system, pathogenic antigens |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Immunoglobulin replacement therapy class)
- CSL Behring · 3 drugs in this class
- Grifols Therapeutics LLC · 2 drugs in this class
- Baxalta now part of Shire · 1 drug in this class
- Biopharma Plasma LLC · 1 drug in this class
- Sir Takhtasinhji General Hospital · 1 drug in this class
- University of Edinburgh · 1 drug in this class
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Cite this brief
Drug Landscape (2026). IV treatment with IGSC, 10% — Competitive Intelligence Brief. https://druglandscape.com/ci/iv-treatment-with-igsc-10. Accessed 2026-05-17.
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