Pharma Focus Asia

Meitheal Pharmaceuticals Secures Exclusive U.S. Licensing Deal for Humira® Biosimilar YUSIMRY® to Enhance Biologics Portfolio

Friday, June 28, 2024

Meitheal Pharmaceuticals, Inc., headquartered in Chicago, has secured exclusive commercial rights in the U.S. for YUSIMRY® (adalimumab-aqvh), a biosimilar of Humira® (adalimumab), through a licensing and supply agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. (HKF).

This agreement represents a significant milestone for Meitheal, strengthening its presence in the biosimilars market and adding a valuable asset poised for substantial growth," said Tom Shea, CEO of Meitheal Pharmaceuticals. He emphasized Meitheal's readiness to expand patient access to high-quality biosimilars like YUSIMRY® while advancing its clinical development.

HKF acquired global rights to YUSIMRY® from Coherus BioSciences, Inc. under an asset purchase agreement, including development and regulatory assets, for an upfront payment of $40 million. The licensing agreement with Meitheal is effective immediately, subject to standard conditions and approvals.

Brian McCarthy, Meitheal's Senior Vice President of Specialty, highlighted the importance of YUSIMRY® in providing a more affordable alternative to Humira® for Americans with autoimmune conditions. He underscored YUSIMRY®'s strategic position in meeting patient needs amid increasing demand for adalimumab biosimilars, supported by investments in production and commercialization.

Meitheal has expanded its biologics portfolio through significant investments, including a $30 million investment in a monoclonal antibody drug substance facility. YUSIMRY® is currently FDA-approved for nine indications, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis, available in prefilled syringe and autoinjector formats.

Eric Tang, President of HKF, expressed confidence in Meitheal's ability to deliver affordable YUSIMRY® to U.S. patients, affirming their commitment to strategic investments in the biosimilars market and accessible healthcare solutions through their partnership.

Meitheal will collaborate closely with Coherus to ensure a smooth transition for YUSIMRY® operations, maintaining comprehensive support for patients and healthcare providers.

YUSIMRY® (adalimumab-aqvh) is a biosimilar of Humira® (adalimumab), a tumor necrosis factor (TNF) blocker used to manage various inflammatory conditions, including rheumatoid arthritis, Crohn’s disease, and psoriasis.

YUSIMRY® carries risks of serious infections, including tuberculosis and fungal infections. Patients should be monitored closely during treatment for signs of infection, and therapy should be discontinued if serious infections develop. Patients with chronic infections or those taking immunosuppressants are at increased risk. Combining YUSIMRY® with certain biologics may also heighten infection risks without additional benefits. Patients considering YUSIMRY® should discuss potential risks and benefits with healthcare providers, particularly if they have a history of infections or reside in areas endemic to fungal diseases.



magazine-slider-imageCytiva - Supor Prime filtersMFA + MMA 20244th Annual Cleaning Validation 20242nd Annual Pharma Impurity Conclave 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference