Summer Colling and Emma Wille speak with Nkiru Ibeanu, Anna Simmons, and David Dahan from the oncology team about some of the most exciting data presented at the 2025 European Society For Medical Oncology conference.
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Summer Colling and Emma Wille speak with Nkiru Ibeanu, Anna Simmons, and David Dahan from the oncology team about some of the most exciting data presented at the 2025 European Society For Medical Oncology conference.
Drug Fix: US FDA Streamlines Biosimilar Development Requirements, Clarifies Inspection Reform
Citeline Podcasts
23 minutes 20 seconds
1 week ago
Drug Fix: US FDA Streamlines Biosimilar Development Requirements, Clarifies Inspection Reform
Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration announcement that a comparative efficacy study is no longer a prerequisite for biosimilar approval (:35), as well as the upcoming guidance stating the interchangeability switching study requirement will be dropped (11:25). They also discuss agency efforts to clarify the intent of the upcoming inspection force “Simple Reform” (15:13).
More On These Topics From The Pink Sheet
US FDA’s Makary Wants Lower Biosimilar Launch Prices As Clinical Study Mandate Changed: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/us-fdas-makary-wants-lower-biosimilar-launch-prices-as-clinical-study-mandate-changed-5ARJRC6QYBBMTLTQ5S46F5YGXQ/
Biosimilar Interchangeability Guidance Eliminating Switching Studies Coming Soon: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biosimilar-interchangeability-guidance-eliminating-switching-studies-coming-soon-ILNP4IGYJZGZLAJVDZ77URZDNQ/
‘Simple Reform’ Not A Step Back From Program Alignment, US FDA’s Elizabeth Miller Argues: https://insights.citeline.com/pink-sheet/compliance/manufacturing/simple-reform-not-a-step-back-from-program-alignment-us-fdas-elizabeth-miller-argues-TCTFWMGBARD6VLRDT7YWUZBJQE/
Citeline Podcasts
Summer Colling and Emma Wille speak with Nkiru Ibeanu, Anna Simmons, and David Dahan from the oncology team about some of the most exciting data presented at the 2025 European Society For Medical Oncology conference.
