The latest news about Samsung Bioepis
• The European Union (EU) label update means that IMRALDI™ (adalimumab) has been approved to be stored in non-refrigerated conditions (up to 25˚C) for up to 28 daysi
• The update is based on a study that demonstrates that Samsung Bioepis’ biosimilar adalimumab is physicochemically and biologically stable for 28 days at room temperature conditions (up to 25˚C)ii
INCHEON, KOREA – June 24, 2019 – Samsung Bioepis Co., Ltd. announced today that the European Medicines Agency (EMA) has approved an update to the label of IMRALDI™ (adalimumab) to extend the maximum storage period at room temperature conditions (up to 25˚C) for up to 28 days.i
“There is evidence to suggest that biologic medicines are not always stored within the recommended temperature range. With this EU label update, our biosimilar adalimumab has now been approved to be stored outside of refrigerated conditions for an additional two weeks,” said Sang-jin Pak, Senior Vice President and Head of Commercial Division, Samsung Bioepis. “We are committed to continually reviewing our biosimilar medicines to further support the patients who need them.”
The EU label update was based on study results examining the stability of the Samsung Bioepis adalimumab formulation at room temperature conditions (25 ± 2 ˚C and 60 ± 5% relative humidity), after being kept in refrigerated conditions (2-8 ˚C) for 36 months, in order to represent a worst-case scenario. Three separate batches were independently tested at 0, 2, and 4 weeks for solution appearance, pH, protein concentration, purity, particulates, biological activity and charge variance.ii
Study results demonstrate that the adalimumab biosimilar, aged to its shelf life of 36 months, is physicochemically and biologically stable for up to 4 weeks at room temperature conditions.ii
Biologic medicines need to be stored under specific conditions, as storage conditions can affect the stability of a biologic medicine, which in turn can have an impact on the medicine’s safety, purity, and potency.iii An observational study that recorded the conditions in which Dutch adult patients kept their biologic disease-modifying antirheumatic drugs (bDMARDs), found that among the 87.0% (255) who completed the study, only 6.7% (17) stored their biologic medicine within the recommended temperature range.iv Another study that observed patients’ storage of an anti-TNF medicine found that among the 276 used injectors, only 11.6% were stored within the recommended temperature range.v
The European Commission (EC) approved IMRALDI™ (adalimumab) in August 2017 for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.
This Press Release is strictly intended to inform a professional audience about the label update for IMRALDI™ (adalimumab). It does not constitute in any way and should not be construed as any form of information, activity or inducement designed to promote products or services.
i European public assessment report (EPAR) for IMRALDI™ (adalimumab). Available at : https://www.ema.europa.eu/en/documents/product-information/imraldi-epar-product-information_en.pdf. Last accessed June 2019
ii Park D, et al. Evaluation of Physicochemical and Biological Stability of 36-Months-Aged SB5 (Adalimumab Biosimilar) for 4 Weeks at Room Temperature. Adv Ther. 2019;36(2):442-450.
iii Impact of Severe Weather Conditions on Biological Products. U.S. Food & Drug Administration. Available at : https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/impact-severe-weather-conditions-biological-products. Last accessed June 2019
iv Vlieland N D, et al. The majority of patients do not store their biologic disease-modifying antirheumatic drugs within the recommended temperature range. Rheumatology. 2016;55:704-709.
v de Jong M J, et al. Exploring conditions for redistribution of anti-tumor necrosis factors to reduce spillage: A study on the quality of anti-tumor necrosis factor home storage. J Gastroenterol Hepatol. 2018 Feb;33(2):426-430.