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FDA INTERNATIONAL INSPECTION APPROACH- PART II

FDA INTERNATIONAL INSPECTION APPROACH- PART 1

Don’t Buy New Cell Line or RCB !! Save Millions by Doing This Instead…

Why 10 Lots are Important

Cliff Notes for New Interchangeability Draft Guidance by FDA

FDA Friend or FOE for Biosimilar Companies

RSS Big Molecule Watch

  • Third Circuit Holds That Granting Discovery Under Section 1782 Is Not a “Final” Judgment June 13, 2025 Alison Siedor
  • Sandoz Launches PYZCHIVA® (Ustekinumab) Autoinjector in Europe June 4, 2025 Christopher Cassella
  • Samsung Bioepis Secures Marketing Approval in Korea for its Biosimilar to Amgen’s Bone Cancer Drug Xgeva June 3, 2025 Beth Ashbridge
  • EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars June 2, 2025 Sam Herron
  • Celltrion, Samsung Bioepis, and Organon Receive Interchangeability Designations for Adalimumab Biosimilars June 2, 2025 Emma Murray
  • FDA Approves Bio-Thera and Hikma’s Ustekinumab Biosimilar May 29, 2025 Riley Wyberg
  • FDA Approves BLA for Novavax’s COVID-19 Vaccine May 23, 2025 Tara Thigpen
  • Biogen Files Suit Against Neurimmune Over Rights to Bispecific Antibody May 21, 2025 Allegra Padula
  • HyClone Seeks to Quash Amgen’s Subpoena Issued in Amgen/Accord Denosumab BPCIA Litigation May 21, 2025 Allegra Padula
  • Regeneron Awarded $407 Million in Amgen Antitrust Suit May 19, 2025 Darlene Staines

RSS BioPharma Reporter

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