Biosimilars Regulatory Roundup for September 2023—Podcast Edition

October 1, 2023

On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

On this episode, we will discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

Show Notes

House Committee Hearing Addresses PBMs, Anticompetitive Drug Pricing Tactics

Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing

Part 1: FDA Workshop Highlights Global Regulatory View on Biosimilar Development

Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward

Alvotech’s Stelara Biosimilar Approved in Japan

EC Approves First MS Biosimilar; Coherus Receives CRL for Neulasta Onpro Competitor

European Commission Approves First Aflibercept Biosimilar

Regulatory Updates From Around the Globe Provide Hope for Biosimilars