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

As Johnson & Johnson'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.

Thursday, Biocon Biologics 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 prospect, called Bmab 1200, is currently under review at the FDA, the biosimilar maker said in a release.

As part of the deal, Biocon Biologics and J&J agreed to dismiss a pending case at the United States Patent and Trademark Office.

Biocon joins several other biosimilar players 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."

Besides Amgen, Johnson & Johnson inked settlements with partners Alvotech and Teva in June 2023, plus Fresenius Kabi and Formycon in August 2023. In addition, the company settled with Celltrion in August 2023.

A few months after those accords, the pharma giant settled with Samsung Bioepis and Sandoz in November 2023.

Those deals will allow for staggered biosimilar launches between February and April of 2025, 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.

While not quite as big of a target, the Stelara situation somewhat resembles the patent cliff for AbbVie's immunology megablockbuster Humira. That drug lost its U.S. exclusivity 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.