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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Cliff Notes for New Interchangeability Draft Guidance by FDA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

  • FDA Issues Its First Freeze-Dried Plasma License August 11, 2026 Lianne Frydendal
  • Genentech Files BPCIA Patent Infringement Suit Against Biocon Over Proposed PERJETA Biosimilar August 7, 2026 Sarah Adam
  • FDA Approves Meitheal Pharmaceuticals’ Insulin Aspart Biosimilar GARZULYS August 7, 2026 Darlene Staines
  • Celltrion Targets European Secukinumab Market with EMA Filing for CT-P55 July 31, 2026 Wendy Leben
  • Accord BioPharma Launches OSVYRTI® and JUBEREQ® Denosumab Biosimilars July 31, 2026 Tara Thigpen
  • Outlook Therapeutics Secures FDA Approval for LYTENAVA™ July 31, 2026 Emma Murray
  • HHS Sets Timeline to End COVID-19 Emergency Use Authorizations July 27, 2026 Yoko Bian
  • Formycon and OneSource Specialty Pharma Partner to Manufacture Biosimilars July 25, 2026 Michael Shriner
  • Teva and Samsung Bioepis Enter Into Commercialization Agreement for OPUVIZ in Canada July 25, 2026 Shauna Perigo
  • Accord BioPharma Announces FDA Approval of Pegfilgrastim Biosimilar July 16, 2026 Timothy Beavers

RSS BioPharma Reporter

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