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. As we covered previously, Janssen and Amgen settled their BPCIA litigation regarding Amgen’s ustekinumab biosimilar product in May 2023….
On April 27, 2023, Matt Wetzel, Life Sciences Partner at Goodwin, will lead a webinar to address the latest updates on the Inflation Reduction Act and the law’s sweeping changes to how the government intends to pay for pharmaceuticals and biologics. The new Medicare price negotiation program, inflation-based rebates, and…
On April 5, 2023, Goodwin’s Matt Wetzel and Heath Ingram published a client alert addressing the initial guidance memorandum issued by the Centers for Medicare & Medicaid Services (CMS) on the Medicare Drug Price Negotiation Program created by the Inflation Reduction Act of 2022. Public comments are due to CMS…