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

 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

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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