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
Opinion: The Inflation Reduction Act is a Step Backward for Biosimilar Competition
$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
FDA Approves High-Concentration Formulation of Samsung Bioepis’ Humira Biosimilar
Eye on Pharma: Celltrion Aims for Adalimumab Interchangeability; Phase 3 Results for Ustekinumab Biosimilar
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
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.