With J&J settlement, Biocon Biologics gets a license to challenge Stelara in the US

29 Feb 2024
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Biocon Biologics on Thursday became the latest biosimilar maker to reveal a Stelara settlement with J&J.
Biocon Biologicsnson's U.S. exclusivity period on its immunology blockbuster Stelara ticks away, another biosimilar player has lined up for the piece of the drug's sales pie.
ThuJohnson & Johnsonlogics said it has inked a Stelara patent settlement with J&J. With the deal, Biocon Biologics has secured a license to allow its biosimilar to enter the U.S. market in February 2025, pending an FDA approval.
The prospeBiocon Biologics1200, is currently under review at the FDA, the biosimilar maker said inBiocon BiologicsFDA
As part of the deal, Bmab 1200ologics and J&J agreed to dismiss aFDAnding case at the United States Patent and Trademark Office.
Biocon joins several Biocon Biologics playJ&J that are lining up to take on Stelara. Amgen, after inking its Stelara patent settlement in May of last year, looks set for the first Stelara biosimilar launch "no later than January 1st, 2025."
Biocons Amgen, Johnson & Johnson inked settlements with partners Alvotech and Teva inAmgen 2023, plus Fresenius Kabi and Formycon in August 2023. In addition, the company settled with Celltrion in August 2023.
A few moAmgenafJohnson & Johnson, the pharma giant settled with SAlvotechioepiTevad Sandoz in NovemberFresenius KabiFormyconCelltrion
Those deals will allow for staggered biosimilar launches betweenSamsung Bioepispril Sandoz5, pending regulatory approvals.
J&J's Stelara brought in nearly $7 billion in the U.S. last year. Its approved uses in the U.S. are plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
J&Jle not quite as big of a target, the Stelara situation somewhat resembles the patent cliff for Abplaque psoriasisy psoriatic arthritisirCrohn's diseasest itulcerative colitis early last year, and its full-year sales fell 32% in turn, after turning out around $20 billion a year in sales at its peak.
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