Fierce Pharma November 1, 2023
The FDA has signed off on Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. But don’t hold your breath waiting for the California biotech to launch its new product.
In May, under the terms of a settlement between the companies, Amgen agreed to delay the launch of its copycat in exchange for J&J dropping a patent infringement lawsuit. The deal keeps Wezlana (ustekinumab-auub) off the market until no later than Jan. 1, 2025.
The agreement also makes it likely that Wezlana will become the first Stelara biosimilar to launch in the U.S. In June, J&J made a similar settlement with Alvotech and Teva to delay the launch of their biosimilar version of Stelara, which has yet to gain...
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