Samsung Bioepis Reports EU Label Update with Extended Storage Conditions for Imraldi (biosimilar, adalimumab)

  • 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

Click here to read full press release/ article | Ref: Samsung Bioepis | Image: Behance