agencies centers-for-medicare-medicaid-services 
IP Law 360
APRIL 11, 2024
sued the Centers for Medicare & Medicaid Services in Washington, D.C., federal court on Wednesday, alleging the agency ignored the company's objection to classifying two of its generics as "innovator drugs," which could impact Sandoz's rebate obligations under Medicaid. Pharmaceutical company Sandoz Inc.
LexBlog IP
JULY 20, 2021
Among the 72 initiatives set forth in the Order are instructions that charge various agencies with tasks to promote generic and biosimilar competition.
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Fish & Richardson Trademark & Copyright Thoughts
MARCH 8, 2021
Around that same time, FDA responded to Pfizer’s August 2018 citizen petition in which the company asked the agency to issue guidance “to ensure truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics, relative to reference product(s).”
LexBlog IP
AUGUST 25, 2023
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. Before the IRA, the government could not set prices for any drugs covered by Medicare. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th.
Fish & Richardson Trademark & Copyright Thoughts
FEBRUARY 4, 2021
Introduction. The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since 2016 and fewer product launches than 2019—as well as a decrease in district court litigation and post-grant proceedings.
LexBlog IP
DECEMBER 30, 2021
Among the initiatives set forth were instructions charging various agencies with tasks to promote generic and biosimilar competition. In 2021, the FDA’s Purple Book went live, providing a searchable database of licensed biological products , including the patent information provided to biosimilar applicants during the patent dance.
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