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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Cliff Notes for New Interchangeability Draft Guidance by FDA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 feed: Big Molecule Watch Big Molecule Watch

  • European Commission Makes Sanofi’s Antitrust Commitments Binding October 23, 2026 Jeremy Jones
  • Alvotech and Advanz Pharma Announce Submission for Proposed Eylea 8 mg Biosimilar October 21, 2026 Alice Yoon
  • FDA Accepts Formycon and Zydus’ Proposed Pembrolizumab Biosimilar for Review October 21, 2026 Alice Yoon
  • Genentech and Biocon Settle Pertuzumab Biosimilar BPCIA Litigation October 20, 2026 Harrison Gunn
  • Teva and Samsung Bioepis Add Up to Six Biosimilar Candidates to Partnership October 19, 2026 Darlene Staines
  • FDA Finalizes Q&A Guidance on Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products October 19, 2026 Sam Herron
  • Fresenius Acquires Remaining 45% Stake in mAbxience for Up to €750 Million October 16, 2026 Sarah Adam
  • Sanofi and Regeneron Expand Immunology Collaboration in Deal Worth Up to $8 Billion October 14, 2026 Emma Murray
  • Celltrion Launches Omalizumab Biosimilar in the United States October 14, 2026 Wendy Leben
  • Sandoz and mABxience Announce Collaboration for Proposed Emicizumab Biosimilar October 13, 2026 Shauna Perigo

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