Biocon Ltd.

Johnson & Johnson has filed for two new pediatric indications as it looks to position its blockbuster immunotherapy Tremfya as a follow-on to its megablockbuster Stelara. If approved, Tremfya would become available to children 6 years and older with moderate-to-severe plaque psoriasis and children 5 years and older with active juvenile psoriatic arthritis. J&J’s immunodermatology disease area leader Liza O’Dowd said in a news release that there is a “critical gap” in the treatment of children and adolescents with those conditions, some of whom experience “debilitating symptoms.” “This milestone underscores our commitment to transform the standard of care for patients of all ages and builds on our expertise and legacy in IL-23 and immune-mediated diseases,” she said. Tremfya was first approved in 2017 for adults with plaque psoriasis. It generated $3.1 billion in 2023 sales, though executives think it could eventually rival the company’s immunosuppressant Stelara, which made $10.9 billion that same year. Tremfya won approval in September to treat ulcerative colitis, expanding for the first time into inflammatory bowel disease, a key area for Stelara. Stelara is approved to treat children 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis. However, biosimilars to Stelara are expected to hit the market in 2025. The latest to win approval is Biocon Biologics’ Yesintek . “When we take a look going forward and what we had seen with Stelara in terms of the strength in IBD and the potential, we think that Tremfya definitely is an asset that is of Stelara’s size or bigger and better,” J&J’s executive VP and worldwide chairman of innovative medicine Jennifer Taubert said on the company’s latest quarterly call in October, according to an AlphaSense transcript.

Biocon Biologics scored an FDA approval for its Stelara biosimilar, marketed as Yesintek, the company announced Monday. Biocon entered into a settlement and licensing agreement with Johnson & Johnson, which owns Stelara, earlier this year, agreeing to commercialize Yesintek in the US no later than Feb. 22, 2025. A representative for the company told Endpoints News that Biocon is “unable to disclose” the price of Yesintek at this time. At least five other biosimilars to Stelara are expected to launch in the first three months of 2025. Stelara (ustekinumab) was first approved by the FDA in 2009, and will begin to see competition on Jan. 1, 2025, with the launch of Amgen’s biosimilar Wezlana. That launch and others in February from Samsung and Biocon already have implications for insurers. Optum Rx and Cigna in September each made moves to prioritize Stelara competition. Stelara pulled in $2.6 billion in the third quarter of this year for J&J, about a 6% decrease from the previous quarter. J&J’s VP of investor relations said during the third-quarter investor call that the decline was “driven by unfavorable net patient mix and share loss,” adding that biosimilar competition had already entered Europe in July and that the company expects biosimilar entry in the US next year. J&J has made at least six deals over the last two years with companies looking to launch biosimilars in 2025, including Amgen and Sandoz. Amgen will likely launch first on Jan. 1, 2025, while Samsung Bioepis , Sandoz , Fresenius Kabi (working with Formycon), and Biocon can launch their respective biosimilars in the US on Feb. 22. Teva and Alvotech in September also won FDA approval for their biosimilar, known as Selarsdi, which they expect to launch in the first quarter of 2025. In addition to the competition, Stelara was also one of the first 10 drugs selected by CMS under the Inflation Reduction Act and is subject to negotiated prices starting in 2026. While there was talk last year of potentially removing Stelara from the list due to the incoming biosimilars, Stelara so far remains subject to negotiations as J&J previously confirmed to Endpoints that it expects Wezlana to launch past the August deadline for competition.

BENGALURU, Karnataka, India I December 01, 2024 I Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today that the U.S. Food and Drug Administration (FDA) has approved YESINTEK™ (Ustekinumab-kfce), a biosimilar to the reference product, Stelara® (Ustekinumab). YESINTEK™, a monoclonal antibody, is approved for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. Biocon Biologics Ltd had previously notified the Stock Exchange on Feb 29, 2024, that the Company had entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize YESINTEK™ in the United States of America no later than on February 22, 2025, upon approval from the U.S. FDA. SOURCE: Biocon Biologics