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Gammaplex 10 — Competitive Intelligence Brief
phase 3
Intravenous immunoglobulin (IVIG)
Fc receptors; pathogenic antibodies and antigens (non-specific)
Immunology
Biologic
Live · refreshed every 30 min
Target snapshot
Gammaplex 10 (Gammaplex 10) — Bio Products Laboratory. Gammaplex 10 is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Gammaplex 10 TARGET | Gammaplex 10 | Bio Products Laboratory | phase 3 | Intravenous immunoglobulin (IVIG) | Fc receptors; pathogenic antibodies and antigens (non-specific) | |
| Gammaplex (5%) | Gammaplex (5%) | Bio Products Laboratory | marketed | Intravenous immunoglobulin (IVIG) | Fc receptors and complement system (indirect mechanism via antibody delivery) | |
| PRIVIGEN (CSL Behring) | PRIVIGEN (CSL Behring) | Hospices Civils de Lyon | marketed | Intravenous immunoglobulin (IVIg) | Fc receptors, complement system, pathogenic antigens and antibodies | |
| IgPro | IgPro | CSL Behring | marketed | Intravenous immunoglobulin (IVIG) | Multiple pathogenic antigens (polyvalent) | |
| Asceniv™ | Asceniv™ | ADMA Biologics, Inc. | marketed | Intravenous immunoglobulin (IVIG) | Polyclonal immunoglobulins (IgG) | |
| Flebogamma 5% DIF | Flebogamma 5% DIF | Instituto Grifols, S.A. | marketed | Intravenous immunoglobulin (IVIG) | Fc receptors, pathogenic antigens and antibodies | |
| Octagam (IVIG) | Octagam (IVIG) | Oslo University Hospital | phase 3 | Intravenous immunoglobulin (IVIG) | Multiple (polyvalent IgG; Fc receptors, complement system) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Intravenous immunoglobulin (IVIG) class)
- CSL Limited · 4 drugs in this class
- Instituto Grifols, S.A. · 2 drugs in this class
- Bio Products Laboratory · 2 drugs in this class
- ADMA Biologics, Inc. · 2 drugs in this class
- Grifols Biologicals, LLC · 1 drug in this class
- Grifols Therapeutics LLC · 1 drug in this class
- Kedrion S.p.A. · 1 drug in this class
- Octapharma · 1 drug in this class
- Oslo University Hospital · 1 drug in this class
- SK Plasma Co., Ltd. · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Gammaplex 10 — Competitive Intelligence Brief. https://druglandscape.com/ci/gammaplex-10. Accessed 2026-06-10.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing