Biosimilars
This week Lori, Greg and Tyler discuss AbbVie: how longtime CEO Richard Gonzalez navigated Humira’s LOE, his victorious retirement announcement, and the future of biosimilars.
On Friday, Alvotech and Teva Pharmaceuticals finally secured the FDA’s greenlight for their Humira biosimilar Simlandi, which now has the regulator’s interchangeability designation.
The Icelandic biotech Thursday said that it has settled its grievances with Johnson & Johnson regarding its Stelara biosimilar in markets with regulatory approval.
Novartis spin-off Sandoz will make an upfront cash payment for the entire Cimerli ophthalmology franchise, including inventories, software and sales and reimbursement teams.
Despite offering discounts that reach as high as 85%, Humira biosimilars are finding it difficult to take market share away from the AbbVie blockbuster, according to a new report from Samsung Bioepis.
The pharmacy benefit management subsidiary of CVS Health is favoring Humira’s biosimilars for its major formularies, with AbbVie’s branded product to be nixed on April 1, 2024.
The two companies have settled all pending U.S. patent litigation, clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of Stelara.
Ahead of the Inflation Reduction Act’s drug price negotiations, the regulator has approved Amgen’s biosimilar challenge to Johnson & Johnson’s Stelara—with an interchangeable designation to boot.
The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.
German biopharma Boehringer Ingelheim is now offering an unbranded version of its interchangeable biosimilar to the AbbVie blockbuster arthritis drug at a deep discount.
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