Module 9 2024

05/09/2024

Evolving Views

⚫ Previously FDA required extensive clinical data to approve biosimilars for filgrastim, pegfilgrastim, insulin and other non glycosylated proteins with measurable relevant PD effects

2019

⚫ Now PD data in healthy subjects and immunogenicity adequate

⚫ Coherus PegFilgrastim

– Entire program in healthy volunteers – Single dose PK/PD study – Immunogenicity – two doses in ~300 patients – Not sure if design discussed with FDA

The Organisation for Professionals in Regulatory Affairs

17

Evolving Views

“While the initial approach to biosimilars was understandably cautious and conservative in that uncharted territory to protect patients' safety, the analytical and scientific progress and accumulated experience with biosimilars continues to reshape regulatory requirements, generally leading to a reduced burden of clinical trials .” — Elena Wolff-Holz et. A 2019 Dec;33(6):621-634 l MHRA guideline : “ in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach.” Guidance on the licensing of biosimilar products - GOV.UK (www.gov.uk) The U.S. Food and Drug Administration (FDA) hosted a virtual public workshop on September 19, 2022, “Increasing the Efficiency of Biosimilar Development Programs.” Discussion as how to maximise use of PD data FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs - 09/19/2022 | FDA

2019

2020

2022

The Organisation for Professionals in Regulatory Affairs

18

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