Biosimilars Regulatory Roundup for August 2022—Podcast Edition

On this episode of Not So Different, we look back at some of the biggest regulatory events to happen in the biosimilar space during August, including 2 European approvals, 2 US approvals, and the advancement of the Inflation Reduction Act of 2022.

This episode is going to be recapping some of the biggest regulatory events to happen in the biosimilar space during the month of August, including 2 European approvals, 2 US approvals, including 1 for an interchangeable biosimilar, and the advancement of the Inflation Reduction Act of 2022.

Show notes

Opinion: Impact of Inflation Reduction Act 2022—Addressing Critics

https://www.centerforbiosimilars.com/view/opinion-impact-of-inflation-reduction-act-2022-addressing-critics

Opinion: The Inflation Reduction Act is a Step Backward for Biosimilar Competition

https://www.centerforbiosimilars.com/view/opinion-the-inflation-reduction-act-is-a-step-backward-for-biosimilar-competition

$35 Insulin Cap for Private Sector Blocked From Budget Reconciliation Bill

https://www.centerforbiosimilars.com/view/-35-insulin-cap-for-private-sector-blocked-from-budget-reconciliation-bill

European Commission Approves Second Lucentis Biosimilar

https://www.centerforbiosimilars.com/view/european-commission-approves-second-lucentis-biosimilar

FDA Approves Coherus’ Cimerli as Interchangeable Biosimilar to Ranibizumab

https://www.centerforbiosimilars.com/view/fda-approves-coherus-cimerli-as-interchangeable-biosimilar-to-ranibizumab

FDA Approves High-Concentration Formulation of Samsung Bioepis’ Humira Biosimilar

https://www.centerforbiosimilars.com/view/fda-approves-high-concentration-formulation-of-samsung-bioepis-humira-biosimilar

https://www.centerforbiosimilars.com/view/fda-approves-high-concentration-formulation-of-samsung-bioepis-humira-biosimilar

Eye on Pharma: Celltrion Aims for Adalimumab Interchangeability; Phase 3 Results for Ustekinumab Biosimilar

https://www.centerforbiosimilars.com/view/eye-on-pharma-celltrion-aims-for-adalimumab-interchangeability-phase-3-results-for-ustekinumab-biosimilar

EC Grants Celltrion Avastin Biosimilar Marketing Authorization

https://www.centerforbiosimilars.com/view/ec-grants-celltrion-avastin-biosimilar-marketing-authorization

BLA Accepted for Fresenius Kabi Tocilizumab Biosimilar

https://www.centerforbiosimilars.com/view/bla-accepted-for-fresenius-kabi-tocilizumab-biosimilar