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Amgen Fails to Block Sandoz' Neupogen Biosimilar, Again
The battle is being closely watched for signs that brand-name drug makers may be able to delay the introduction of biosimilars, which are cheaper versions of brand-name biologics.
For the second time this month, Amgen has lost a battle over its effort to block a biosimilar version of its Neupogen drug, a $5.7 billion seller that is used to fend off infections during chemotherapy. This time, the FDA denied a citizen’s petition the biotech filed arguing that Sandoz, which plans to sell a biosimilar, violated federal law by failing to provide it with needed information by a specified deadline.
In its filing, Amgen maintained that Sandoz, which is the Novartis generic drug unit, was required to provide a complete copy of its biosimilar marketing application 20 days after it was submitted to the FDA. The biotech also sought Sandoz manufacturing plans. Moreover, Amgen insisted that the FDA has the power to require companies to provide biosimilar applications to brand-name drug makers.
Read the complete article on The Wall Street Journal: http://on.wsj.com/19FP4Ai
Bridging the Vaccination Gap: Insights on Global Immunization Challenges
July 30th 2024On this episode of Managed Care Cast, we speak with Jeffery A. Goad, PharmD, MPH, 2024-2025 president of the National Foundation for Infectious Diseases, on the recent report from the World Health Organization and UNICEF on public immunization rates, with national and global health implications.
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Double Trouble: High-Deductible Plans Raise Maternity Care Costs Across 2 Calendar Years
June 27th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the June 2024 issue of The American Journal of Managed Care® about how annual high-deductible insurance plans increase maternity care costs when pregnancies cross 2 calendar years.
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