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INCHEON, Korea & JERSEY CITY, N.J. - Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) have announced the U.S. Food and Drug Administration’s (FDA) approval of HADLIMA™ (adalimumab-bwwd) as an interchangeable biosimilar to Humira® (adalimumab). This approval includes both high- and low-concentration formulations of HADLIMA™ in various presentations, such as autoinjectors and prefilled syringes.
The FDA’s designation, which allows pharmacists to substitute HADLIMA™ for Humira® without prescriber consultation according to state pharmacy laws, follows a previous interchangeability designation for HADLIMA™’s low-concentration presentations in June 2024. This expanded approval now encompasses all presentations of the reference product.
Clinical data supporting this interchangeability decision came from a study comparing the pharmacokinetics, efficacy, safety, and immunogenicity of EU-sourced Humira® and the high-concentration SB5 (adalimumab biosimilar) in patients with moderate to severe plaque psoriasis. The study outcomes indicated comparable results between patients who alternated between the two formulations and those who continuously received Humira®.
Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon, highlighted the potential cost savings for patients, citing data where patients paid significantly less out-of-pocket for HADLIMA™ compared to Humira®. Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, emphasized the importance of the designation in increasing access to biosimilars.
HADLIMA™, a tumor necrosis factor (TNF) blocker, is indicated for various conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. Patients using adalimumab products are advised to be aware of the risks of serious infections and malignancies.
The biosimilar was first approved by the FDA in 2019, with commercial availability in the U.S. starting in 2023. This announcement is based on a press release statement from Samsung Bioepis Co., Ltd. and Organon & Co.
In other recent news, Organon & Co. reported its first-quarter earnings for 2025, revealing mixed financial results. The company’s earnings per share (EPS) exceeded expectations at $1.02, surpassing the forecast of $0.91, but revenue fell short at $1.51 billion against a projected $1.55 billion. Despite the earnings beat, Organon announced a significant dividend cut, a move aimed at accelerating debt reduction. BNP Paribas Exane responded by lowering its price target for Organon from $29 to $16, while maintaining an Outperform rating, citing the company’s strategic focus on women’s health and potential for business development.
The company has projected that its product Nexplanon will drive over $1 billion in sales for 2025, and it is implementing restructuring initiatives expected to yield $200 million in annual savings. Organon aims to reduce its leverage ratio below 4x by the end of the year. Additionally, the successful launch of VTAMA for atopic dermatitis was highlighted as a positive development for the company’s future. BNP Paribas Exane analysts expressed optimism about Organon’s investment potential, particularly in light of its strategic moves and focus on women’s health.
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