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Meitheal Pharmaceuticals Announces FDA Approval of High-Concentration Formulation of YUSIMRY®, a Biosimilar to Humira®

Business Wire

  • YUSIMRY® (adalimumab-aqvh), a citrate-free, high-concentration formulation, is approved for nine indications of reference product Humira®, and is now interchangeable

  • Approval enables Meitheal to offer YUSIMRY® in both low and high-concentration formulations

  • Approval further expands Meitheal's biosimilar portfolio and supports the Company's commitment to providing sustainable access to critical medicines

CHICAGO, September 28, 2026--Meitheal Pharmaceuticals, Inc. ("Meitheal"), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced that the U.S. Food and Drug Administration ("FDA") has approved a high-concentration formulation ("HCF") for YUSIMRY® (adalimumab-aqvh), as an interchangeable biosimilar to Humira®. Emerge Bioscience Pte. Ltd. ("Emerge") holds the approved Biologics License Application for YUSIMRY®. Meitheal serves as the product's U.S. Regulatory Agent and holds exclusive U.S. commercialization rights under its license agreement with Emerge.

"With this approval, we now have FDA approval for both low and high-concentration formulations of YUSIMRY®, marking an important step in expanding treatment options for patients with certain chronic autoimmune diseases," said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. "By leveraging our development and commercialization expertise together with the manufacturing and supply chain capabilities of our partners, we will continue working to expand access to high-quality, affordable treatment options."

Recent milestones, including the FDA approval of Garzulys™ (insulin aspart-fsan) injection in July 2026 and the approval of the interchangeable high concentration formulation of YUSIMRY®, highlight the continued growth of Meitheal's biologics business. Supported by its parent company, Hong Kong King-Friend Industrial Co., Ltd. ("HKF"), Meitheal continues to expand patient access to affordable therapies through more than $500 million in capital and research and development investments, including $30 million in a monoclonal antibody drug substance facility.

"We are thrilled to celebrate both the FDA approval of Garzulys™ and the approval of the high-concentration formulation of YUSIMRY®," said Eric Tang, President of HKF. "Together, these achievements reinforce our commitment to increasing access to affordable biologic medicines. We look forward to continuing our strategic partnership with Meitheal and investing in solutions that help improve patient access and outcomes."

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