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Celltrion Inc.

www.celltrion.com/en

Latest From Celltrion Inc.

Biosimilars Statistical Guidance Reflects Early Development Approach

US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.

Biosimilars Research & Development

Pfizer v. J&J Sets Stage For Biosimilar Showdown Over Exclusive Contracts

Pfizer's suit claims J&J coerced payers by vowing to withhold all Remicade rebates if any of Pfizer's biosimilar Inflectra is reimbursed, but J&J says Pfizer has failed to show the value of Inflectra.

Biosimilars Legal Issues

Pfizer Sets The Stage For A Biosimilar Showdown Over Exclusive Contracts

Pfizer filed a lawsuit against J&J over its efforts to block sales of Pfizer's biosimilar Inflectra through exclusive contracting for Remicade. The suit claims J&J coerced payers by vowing to withhold all Remicade rebates if any Inflectra is reimbursed. J&J says Pfizer has failed to show the value of Inflectra.

Biosimilars Legal Issues

FDA Hits Two More Asian Firms With Drug GMP Warning Letters

The spate of recent warning letters going to foreign pharmaceutical manufacturers continues as two Asian firms get into trouble for GMP violations: Firson Co. in South Korea and Wuxi Medical Instrument Factory in China.

Manufacturing Quality
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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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