Biosimilar Newsletter Archive

  1. 12.07.23 -- FDA Warning Letters Dipped, But Don't Get Cozy 12/7/2023
    12/07/23 Biosimilar Development Newsletter
  2. 11.30.23 -- Sandoz launches Hyrimoz (adalimumab) High-Concentration Formulation In Europe 11/30/2023
    11/30/23 Biosimilar Development Newsletter
  3. 11.22.23 -- Preformulation Of Excipients In Biologics Development 11/22/2023
    11/22/23 Biosimilar Development Newsletter
  4. 11.16.23 -- Understanding The FDA's Current Focus On REMS 11/16/2023
    11/16/23 Biosimilar Development Newsletter
  5. 11.13.23 -- Strategies To Industrialize Lentivirus And AAV Processes 11/13/2023

    11/13/23 Biosimilar Development Newsletter

  6. 11.09.23 -- Strategies For mAb And mAb Variant Chromatography Process Development 11/9/2023

    11/09/23 Biosimilar Development Newsletter

  7. 11.09.23 -- Legal & IP Protection For New Biotechs 11/9/2023
    11/09/23 Biosimilar Development Newsletter
  8. 11.06.23 -- Design A Successful Viral Clearance Study For Your Biologic 11/6/2023

    11/06/23 Biosimilar Development Newsletter

  9. 11.02.23 -- FDA Updates Labeling Recommendations For Biosimilar Products 11/2/2023
    11/02/23 Biosimilar Development Newsletter
  10. 10.26.23 -- 5 Best Practices For Responding To FDA Form 483 Inspection Observations 10/26/2023
    10/26/23 Biosimilar Development Newsletter