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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Cliff Notes for New Interchangeability Draft Guidance by FDA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

  • FDA Approves Celltrion’s Aflibercept Biosimilar October 14, 2025 Riley Wyberg
  • Amgen and Biocon Settle Denosumab BPCIA Case October 14, 2025 Christopher Cassella
  • Celltrion Announces Launch of AVTOZMA® (tocilizumab-anoh) Intravenous Formulation in the United States October 13, 2025 Tara Thigpen
  • Kashiv BioSciences Omalizumab Biosimilar Application Submitted to FDA, Accepted by EMA October 9, 2025 Zachariah Holmes
  • Biogen Ordered to Pay Genentech $88.3 Million in Past Royalties on Cabilly Patents October 7, 2025 Darlene Staines
  • PTAB Issues Four IPR Written Decisions in Merck and Johns Hopkins Pembrolizumab Dispute October 6, 2025 Darlene Staines
  • Amgen and Samsung Bioepis Settle Denosumab BPCIA Case October 6, 2025 Darlene Staines
  • Court Denies Amgen Motion to Dismiss in Etanercept Antitrust Case October 6, 2025 Darlene Staines
  • FDA Approves Seventh Denosumab Biosimilar: Richter and Hikma’s Enoby and Xtrenbo October 2, 2025 Harrison Gunn
  • Aflibercept BPCIA Multi-District Litigation Updates September 30, 2025 Gabriella Montes

RSS BioPharma Reporter

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