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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
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
The Future of Biosimilar Gene Therapies: Key Issues and Potential
September 11th 2024While biosimilars could potentially lower costs and improve access to gene therapies, significant hurdles in regulation, manufacturing, intellectual property, and market size pose challenges to their development and market entry.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
BioRationality: FDA Opens Up Biosimilar Inquiries on Reddit
August 26th 2024Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum—where a representative will answer complex biosimilar questions—encourages clearing misconceptions, and advocates for updates to the Biologics Price Competition and Innovation Act guidelines.
CMS Announces New Drug Prices Under the IRA, Including for Stelara and Enbrel
August 19th 2024CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.
