• The EU label update is based on the study examining the stability of Imraldi formulation at room temp. (25 ± 2 ˚C and 60 ± 5% relative humidity)- post storing in refrigerated conditions (2-8 ˚C) for 36 mos. The separate three batches were tested at 0/2/4 wks. for solution appearance- pH- protein concentration- purity- particulates- biological activity and charge variance
• The study demonstrated that the biosimilar aged to its shelf life of 36 months- is physicochemically and biologically stable for up to 4 weeks at room temperature conditions
• Imraldi (adalimumab) is a mAb with EU label update to be stored in non-refrigerated conditions (up to 25˚C) up to 28 days and is already approved by EU in 2017 for RA- JIA- axSpA- psoriatic arthritis- psoriasis- including pediatric plaque psoriasis

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