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Fresenius Kabi SwissBioSim GmbH — Portfolio Competitive Intelligence Brief

Fresenius Kabi SwissBioSim GmbH pipeline: 0 marketed, 0 filed, 6 Phase 3, 0 Phase 2. Recent regulatory actions, upcoming PDUFA, patent timeline, top competitor overlap.

0 marketed 0 filed 6 Phase 3 0 Phase 2 2 Phase 1 Live · 30-min refresh

Portfolio leaders (marketed + Phase 3 / filed)

DrugGenericPhaseClassTargetAreaFirst approval
EU-Humira EU-Humira phase 3
FKS518 FKS518 phase 3 Calcineurin inhibitor Calcineurin (via FKBP12 binding) Immunology
US-licensed Prolia (Amgen) US-licensed Prolia (Amgen) phase 3 Denosumab RANKL Osteoporosis
MSB11022 MSB11022 phase 3 Monoclonal antibody (biosimilar) HER2 (human epidermal growth factor receptor 2) Oncology
EU-approved RoActemra EU-approved RoActemra phase 3 IL-6 receptor antagonist (monoclonal antibody) IL-6R (Interleukin-6 receptor) Immunology
MSB11456 MSB11456 phase 3 Monoclonal antibody (biosimilar) HER2 (human epidermal growth factor receptor 2) Oncology

Therapeutic area mix

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this portfolio.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this portfolio.

Patent timeline (forward window)

No upcoming patent expiries for this portfolio.

Competitive overlap (companies sharing drug classes)

  1. Celltrion · 2 shared drug classes
  2. Hoffmann-La Roche · 2 shared drug classes
  3. Allergan · 1 shared drug class
  4. Armando Torres Ramírez · 1 shared drug class
  5. Assistance Publique - Hôpitaux de Paris · 1 shared drug class
  6. Astellas Pharma China, Inc. · 1 shared drug class
  7. Astellas Pharma Europe Ltd. · 1 shared drug class
  8. Andrew B Adams · 1 shared drug class

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Cite this brief

Drug Landscape (2026). Fresenius Kabi SwissBioSim GmbH — Portfolio Competitive Intelligence Brief. https://druglandscape.com/ci/company/fresenius-kabi-swissbiosim-gmbh. Accessed 2026-05-17.

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