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LinkedIn Articles

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Cliff Notes for New Interchangeability Draft Guidance by FDA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

  • Lupin and Zentiva Reach Agreement to Commercialize Certolizumab Pegol Biosimilar July 16, 2025 Joseph Molinari
  • Denosumab Updates: Wyost and Jubbonti Launch as First Denosumab Biosimilars in the U.S. July 10, 2025 Allegra Padula
  • EMA Adopts Positive Opinions for Multiple Biosimilars July 3, 2025 Allegra Padula
  • Amgen Files BPCIA Complaints Against Biocon, Shanghai Henlius/Organon and Hikma/Gideon Richter Regarding Denosumab Biosimilars July 2, 2025 Yoko Bian
  • Kashiv BioSciences Reports Positive Topline Results for XOLAIR® Biosimilar Candidate ADL-018 June 30, 2025 Joseph Molinari
  • BioNTech Announces Transaction to Acquire CureVac June 28, 2025 Tara Thigpen
  • Teva and Fosun Partner to Develop a Novel Immunotherapy Targeting Melanoma and Other Cancers June 23, 2025 Darlene Staines
  • FDA Approves Celltrion’s New Pediatric Formulation of STEQEYMA, Expanding Dosing Flexibility June 23, 2025 Yoko Bian
  • Regeneron Files Another Complaint Against Amgen in Aflibercept BPCIA Litigation June 20, 2025 Allegra Padula
  • Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent June 20, 2025 Grace Truong

RSS BioPharma Reporter

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