In a significant development in the pharmaceutical industry, the FDA, with insights from @MBHB, has approved three interchangeable low-cost biosimilar drugs in 2024. This move comes amid discussions on the future of biosimilar interchangeability. The Biden administration has proposed scrapping the interchangeable biologics designation, aiming to make all biosimilars interchangeable. This proposal has sparked a debate on the role of the FDA in the process, with concerns being raised about the potential impact on physician practices lacking access to 340B discounts. A report by @IQVIA_global highlighted the challenges faced by these practices, particularly in light of the IRA and MFP-based payment changes, with an opinion piece stating 'My $0.02' on how these changes could worsen the situation. Additionally, there are concerns about the implications for rebates and patient out-of-pocket issues.
⚡️ Russian anti-Kremlin militia break into Russia from Ukraine. The Freedom of Russia Legion and the Siberian Battalion crossed the border into Russia from Ukraine to conduct combat operations, according to the Russian anti-Kremlin armed groups. https://t.co/bS8MdqYHC0
Biosimilar Interchangeability Designation Would Be Nixed Under Biden Proposal https://t.co/VEuKMjEgud #PinkSheet
Biden administration wants to scrap interchangeable biologics designation, make all biosimilars interchangeable https://t.co/fDxB6yk84K
Basic idea of making biosimilars substitutable at pharmacy is key; but idea of stripping this determination away from FDA is troubling. FDA needs to be given a clear path for granting equivalent of AB rating on the biosimilar side, and a clear push to make use of the provision. https://t.co/qHzZslwR1i
FDA Approves Three Interchangeable Biosimilar Drugs in 2024 https://t.co/hVe6zGZVBc | by @MBHB
Thoughtful @IQVIA_global report: Low-cost #biosimilars hurt #physician practices that lack access to #340B discounts My $0.02: #IRA & MFP-based payment will make this much, much worse! Also good stuff on #rebates and patient OOP issues ==> https://t.co/Ut6BtbEB2d https://t.co/E8ai7XrsMJ