Remove 2027 Remove Biosimilars Remove Drug Pricing
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FDA Approves Amgen’s WEZLANA As Biosimilar to and Interchangeable With Janssen’s STELARA (ustekinumab) – Stelara Is One of the 10 Drugs Selected by CMS for Drug Price Negotiations Under the Inflation Reduction Act

Big Molecule Watch

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA. In that case, according to CMS’s guidance, STELARA would cease to be “selected” on January 1, 2027.

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NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

The NHC supports the efforts to reduce out-of-pocket costs for Medicare beneficiaries and appreciates CMS’ work to establish a process that seeks to incorporate patient perspectives into drug pricing policy. Even well-intentioned policies can create access disparities if communication and operational support are lacking.

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AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

FDA Law Blog: Biosimilars

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it.

Dosage 64
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March 2024 Newsletter

Safe Biologics

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.