No clinically meaningful differences from HUMIRA1
YUSIMRY proved biosimilarity to HUMIRA in 2 clinical studies, one study establishing similar pharmacokinetics and immunogenicity and the other establishing similar efficacy and safety.2
Approval of biosimilars is based on non-clinical in vivo and in vitro product characterization, followed by comparative clinical assessment of pharmacokinetics, immunogenicity, and efficacy/safety.3
WARNING: SERIOUS INFECTIONS and MALIGNANCY
See prescribing information for complete boxed warning.
WARNINGS AND PRECAUTIONS
Most common adverse reactions (>10%) are: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache and rash.
1. YUSIMRY™ (adalimumab-aqvh) prescribing information. Coherus BioSciences, Inc. 2. CSR Study CHS-1420-02 and Study CHS-1420-03 Coherus BioSciences, Inc. Data on file. 3. 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-product