FDA Approves High-Concentration, Interchangeable YUSIMRY as Humira Biosimilar
核心洞察
Meitheal Pharmaceuticals (搜索) announced FDA approval of a citrate-free, high-concentration formulation of YUSIMRY (adalimumab-aqvh) as an interchangeable biosimilar to Humira.
The approval covers all nine Humira indications and lets Meitheal offer YUSIMRY in both low and high-concentration formulations, in autoinjector and prefilled syringe presentations.
Emerge Bioscience (搜索) holds the Biologics License Application, while Meitheal serves as U.S. regulatory agent and holds exclusive U.S. commercialization rights.
Meitheal Pharmaceuticals (搜索), Inc. announced that the U.S. Food and Drug Administration has approved a high-concentration formulation (HCF) of YUSIMRY (adalimumab-aqvh) as an interchangeable biosimilar to Humira (adalimumab). The citrate-free high-concentration product is approved for the nine indications of the reference product, and the company said the decision allows it to offer YUSIMRY in both low and high-concentration formulations.
Emerge Bioscience (搜索) Pte. Ltd. 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 (搜索). "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."
Formulations and Administration
YUSIMRY is FDA approved as interchangeable with Humira for all nine approved indications. The product is available in both low and high-concentration formulations in an autoinjector, and as a prefilled syringe in the low concentration formulation. Meitheal noted that adalimumab remains an important treatment option across multiple chronic inflammatory diseases.
Indications
YUSIMRY (adalimumab-aqvh) is a tumor necrosis factor (搜索) (TNF) blocker. It is indicated to reduce the signs and symptoms of rheumatoid arthritis (搜索), juvenile idiopathic arthritis (搜索), psoriatic arthritis (搜索) and ankylosing spondylitis (搜索), and to treat Crohn's disease (搜索), ulcerative colitis (搜索), plaque psoriasis (搜索), hidradenitis suppurativa (搜索) and uveitis (搜索).
In rheumatoid arthritis (搜索), the product is indicated alone or in combination with methotrexate or other non-biologic DMARDs for reducing signs and symptoms, inducing major clinical response, inhibiting progression of structural damage and improving physical function in adults with moderately to severely active disease. In polyarticular juvenile idiopathic arthritis (搜索), it is indicated alone or in combination with methotrexate for patients 2 years of age and older with moderately to severely active disease. For psoriatic arthritis (搜索), it is indicated alone or in combination with non-biologic DMARDs in adults with active disease, and for ankylosing spondylitis (搜索) in adults with active disease.
Crohn's disease (搜索) is covered in adults and pediatric patients 6 years of age and older with moderately to severely active disease, while ulcerative colitis (搜索) is covered in adults with moderately to severely active disease. The effectiveness of YUSIMRY has not been established in patients who have lost response to or were intolerant to TNF blockers. Plaque psoriasis (搜索) is covered in adults with moderate to severe chronic disease who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate, with the product administered only to patients who will be closely monitored with regular follow-up visits. Hidradenitis suppurativa (搜索) is covered in adults with moderate to severe disease, and uveitis (搜索) in adults with non-infectious intermediate, posterior and panuveitis.
Safety Profile
YUSIMRY carries boxed warnings for serious infections and malignancy. Patients treated with the product are at increased risk for serious infections that may lead to hospitalization or death, most often in patients taking concomitant immunosuppressants such as methotrexate or corticosteroids. Reported infections include active tuberculosis, including reactivation of latent TB, invasive fungal infections such as histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis, and bacterial, viral and other infections due to opportunistic pathogens including Legionella and Listeria. Treatment should be discontinued if a patient develops a serious infection or sepsis, and therapy should not be started during an active infection, including localized infections.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab. Postmarketing cases of hepatosplenic T-cell lymphoma, a rare and aggressive T-cell lymphoma with a fatal course, have been reported with TNF blockers including adalimumab, mostly in patients with Crohn's disease (搜索) or ulcerative colitis (搜索) and mostly in adolescent and young adult males, nearly all of whom had received azathioprine or 6-mercaptopurine concomitantly at or prior to diagnosis. In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population, and non-melanoma skin cancer was reported in adalimumab-treated patients.
Other labeled risks include anaphylaxis and angioneurotic edema, hepatitis B virus reactivation in chronic carriers, rare new onset or exacerbation of central nervous system and peripheral demyelinating diseases including multiple sclerosis, optic neuritis and Guillain-Barré syndrome, rare pancytopenia including aplastic anemia, worsening and new onset congestive heart failure, and formation of autoantibodies with rare lupus-like syndrome. Patients on YUSIMRY should not receive live vaccines. Adalimumab is actively transferred across the placenta during the third trimester and may affect immune response in the in utero exposed infant, with the safety of live or live-attenuated vaccines in exposed infants unknown.
The most common adverse reactions in adalimumab clinical trials, occurring in more than 10% of patients, were infections such as upper respiratory infection and sinusitis, injection site reactions, headache and rash. Concomitant administration with other biologic DMARDs such as anakinra or abatacept, or with other TNF blockers, is not recommended.
Pipeline and Manufacturing Context
Meitheal said the YUSIMRY approval follows the FDA approval of Garzulys (搜索) (insulin aspart-fsan (搜索)) injection in July 2026, and that both milestones reflect growth of its biologics business. Supported by parent company Hong Kong King-Friend Industrial (搜索) Co., Ltd., Meitheal said it 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 (搜索) 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."
Meitheal, founded in 2017 and headquartered in Chicago, markets more than 80 FDA-approved products across therapeutic areas including anti-infectives, oncology, anesthesia, diabetes, critical care and fertility. Emerge Bioscience (搜索), established in 2024 and based in Singapore, is a subsidiary of Nanjing King-Friend Biochemical Pharmaceutical (搜索) Co., Ltd., an integrated biopharmaceutical company founded in 1986 and headquartered in Nanjing, China, engaged in research, development and manufacturing of active pharmaceutical ingredients and finished dosage forms.