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Latest From Celltrion Inc.
US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking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.
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.
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.
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.
- Large Molecule
- Contract Research, Toxicology Testing-CRO
- Generic Drugs
- Therapeutic Areas
- Immune Disorders
- Infectious & Viral Diseases
- Musculoskeletal & Connective Tissue Disorders
- Respiratory, Pulmonary
- South Korea
- Pacific Rim
- Parent & Subsidiaries
- Celltrion Inc.
- Senior Management
- Hyoung-Ki Kim, Co-CEO
- Contact Info
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Incheon City, 406-840
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