Made to be affordable, proven to be similar1-3
YUSIMRY is part of an effort to help patients access less expensive treatment while maintaining efficacy and safety.1,3,4
YUSIMRY™ (adalimumab-aqvh) is a biosimilar to HUMIRA® (adalimumab).1 YUSIMRY has comparable efficacy, safety, and tolerability, as well as similar indications, so patients don't have to compromise.1
Safe and well-tolerated1,2,6
Well tolerated in healthy volunteers and developed for patient comfort with citrate-free formula and latex-free design
YUSIMRY underwent strict FDA approval requirements to confirm biosimilarity.
Designed to support self-administration2
The YUSIMRY pen could make self-administration easier for some patients.
Proven biosimilarity between YUSIMRY and HUMIRA1
No clinically meaningful differences were observed in patients who were switched from HUMIRA to YUSIMRY.
YUSIMRY blocks TNF, helping relieve the inflammation that leads to joint pain, digestive issues, and other autoimmune responses1
YUSIMRY is a TNF inhibitor, designed to relieve symptoms of chronic inflammatory disease such as joint pain and digestive issues. Studied under strict FDA requirements, YUSIMRY is proven to be highly similar with no clinically meaningful differences to HUMIRA and is approved for a wide range of indications across rheumatology, gastroenterology, and dermatology.1
YUSIMRY can cause serious infections and malignancies.
Choose your specialty to see the full list of YUSIMRY indications1:
Rheumatoid Arthritis (RA)
YUSIMRY is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.1
Juvenile Idiopathic Arthritis (JIA)
YUSIMRY is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.1
Psoriatic Arthritis (PsA)
YUSIMRY is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.1
Ulcerative Colitis (UC)
YUSIMRY is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.1
Limitations of Use
The effectiveness of YUSIMRY has not been established in patients who have lost response to or were intolerant to TNF blockers.1
Plaque Psoriasis (Ps)
YUSIMRY is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. YUSIMRY should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.1
Hidradenitis Suppurativa (HS)
YUSIMRY is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.1
Establishing biosimilarity for YUSIMRY
YUSIMRY is a biosimilar, rigorously compared with its reference biologic to confirm bioequivalent pharmacokinetics and establish highly similar or comparable efficacy and safety profiles.1,7
The FDA recommends a stepwise approach for biosimilar development6,8
Reference product development6,8
The stepwise approach for biosimilars is different from the developmental model used for reference products, in which clinical trial data in the intended patient population provide the basis for approval.
In the biosimilar development paradigm, the analytical assessment forms the foundation of the totality of evidence, and the nonclinical data, together with pharmacokinetics/pharmacodynamics (PK/PD), immunogenicity, and safety data, support the demonstration of biosimilarity.
All FDA-required criteria were met to confirm biosimilarity between YUSIMRY and HUMIRA1,6
1. YUSIMRY™ (adalimumab-aqvh) prescribing information. Coherus BioSciences, Inc. 2. Design Validation, Coherus BioSciences, Inc. Data on file. 3. Mulcahy A, Buttorff C, Finegold K, et al. Projected US savings from biosimilars, 2021-2025. Am J Manag Care. 2022;28(7):329-335. 4. Boccia R, Jacobs I, Popovian R, de Lima Lopes Jr G. Can biosimilars help achieve the goals of US health care reform? Cancer Manag Res. 2017;9:197-205. 5. Nash P, Vanhoof J, Hall S, et al. Randomized crossover comparison of injection site pain with 40 mg/0.4 or 0.8 mL formulations of adalimumab in patients with rheumatoid arthritis. Rheumatol Ther. 2016;3:257-270. 6. US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry. April 2015. Accessed April 25, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product 7. US Food and Drug Administration. Biological Product Definitions. 2022. Accessed April 25, 2023. https://www.fda.gov/files/drugs-published/Biological-Product-Definitions.pdf 8. Dougherty MK, Zineh I, Christl L. Perspectives on the current state of the biosimilar regulatory pathway in the United States. Clin Pharmacol Ther. 2018;103(1):36-39.