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Herceptin Hylecta® — Competitive Intelligence Brief

Herceptin Hylecta® (Herceptin Hylecta®) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: HER2-targeted monoclonal antibody. Area: Oncology.

marketed HER2-targeted monoclonal antibody HER2 (human epidermal growth factor receptor 2) Oncology Biologic Live · refreshed every 30 min

Target snapshot

Herceptin Hylecta® (Herceptin Hylecta®) — Biocon Biologics UK PLC. Herceptin Hylecta is a subcutaneous formulation of trastuzumab that binds to HER2 receptors on cancer cells to block growth signaling and trigger immune-mediated cell death.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Herceptin Hylecta® TARGET Herceptin Hylecta® Biocon Biologics UK PLC marketed HER2-targeted monoclonal antibody HER2 (human epidermal growth factor receptor 2)
Trastuzumab + Pertuzumab Trastuzumab + Pertuzumab Massachusetts General Hospital marketed HER2-targeted monoclonal antibody combination HER2 (human epidermal growth factor receptor 2)
trastuzumab (H) trastuzumab (H) Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University marketed HER2-targeted monoclonal antibody HER2 (human epidermal growth factor receptor 2)
Pertuzumab + trastuzumab Pertuzumab + trastuzumab European Organisation for Research and Treatment of Cancer - EORTC marketed HER2-targeted monoclonal antibody combination HER2 (human epidermal growth factor receptor 2)
Pertuzumab and Trastuzumab Pertuzumab and Trastuzumab QuantumLeap Healthcare Collaborative marketed HER2-targeted monoclonal antibody combination HER2 (human epidermal growth factor receptor 2)
Pertuzumab and Trastuzumab FDC SC Pertuzumab and Trastuzumab FDC SC Hoffmann-La Roche phase 3 HER2-targeted monoclonal antibody combination HER2 (human epidermal growth factor receptor 2)
FDC of Pertuzumab and Trastuzumab SC FDC of Pertuzumab and Trastuzumab SC Hoffmann-La Roche phase 3 HER2-targeted monoclonal antibody combination HER2 (human epidermal growth factor receptor 2)

Recent regulatory actions (last 90 days)

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

Upcoming PDUFA dates (next 180 days)

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

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (HER2-targeted monoclonal antibody class)

  1. Spanish Breast Cancer Research Group · 3 drugs in this class
  2. Hoffmann-La Roche · 2 drugs in this class
  3. Samsung Bioepis Co., Ltd. · 1 drug in this class
  4. Biocon Biologics UK PLC · 1 drug in this class
  5. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · 1 drug in this class
  6. Tanvex BioPharma USA, Inc. · 1 drug in this class
  7. Zydus Lifesciences Limited · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Herceptin Hylecta® — Competitive Intelligence Brief. https://druglandscape.com/ci/herceptin-hylecta. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing