Biosimilars Regulatory Roundup for September 2023—Podcast Edition

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