Biosimilars Regulatory Roundup For September 2023– Podcast Edition
Season 6, Episode 18, Oct 02, 2023, 11:00 AM
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
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