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Celltrion Inc.

www.celltrion.com/en

Latest From Celltrion Inc.

Biosimilar Sponsors Want Off-The-Record Labeling Discussions With US FDA

Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions written record; negotiations for BsUFA III may be opportunity to create such a process.

Biosimilars Intellectual Property

Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News

The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Drug Review

US Trastuzumab Competition Heats Up

Mylan and Biocon have launched their Ogivri trastuzumab biosimilar in the US, marking the second biosimilar rival to Herceptin and leading a new wave of trastuzumab biosimilars expected to arrive in the US early next year.

Biosimilars Launches

Celltrion Lays Out Europe Launch Plans, Strategy Following Remsima SC Approval

Celltrion plans to launch its new subcutaneous formulation of Remsima in Europe next year beginning with Germany and then to get approvals for all indications by mid-2020. It has indicated that prices will be higher than first-line anti-TNF treatments but competitive with second-line rheumatoid arthritis treatments, as it pursues a strategy to gain substantial market share.

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Company Information

  • Industry
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Contract Research, Toxicology Testing-CRO
  • Pharmaceuticals
    • Generic Drugs
  • Services
  • Therapeutic Areas
  • Cancer
  • Dermatology
  • Gastrointestinal
  • Immune Disorders
  • Infectious & Viral Diseases
  • Inflammation
  • Musculoskeletal & Connective Tissue Disorders
  • Respiratory, Pulmonary
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • Asia
      • Pacific Rim
        • South Korea
  • Parent & Subsidiaries
  • Celltrion Inc.
  • Senior Management
  • Hyoung-Ki Kim, Co-CEO
  • Contact Info
  • Celltrion Inc.
    Phone: (82) 32 850 5000
    23 Academy-ro
    Yeonsu-gu
    Incheon City, 406-840
    South Korea
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