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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
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.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.
