Samsung Bioepis Gains EU Label Update for Biosimilar Adalimumab, Imraldi

Biosimilar developer Samsung Bioepis has gained an updated label for its biosimilar adalimumab, Imraldi, referencing Humira. The biosimilar is now approved for storage in nonrefrigerated conditions for up to 28 days. This update means that the biosimilar can now be stored for an additional 2 weeks at room temperature.

According to Samsung Bioepis, the update is welcome news, given that patients may have difficulty storing their biologics within the recommended temperature ranges.

In a statement announcing the EU update, the company pointed to data from an observational study among adult patients in the Netherlands that found that only 6.7% of patients stored their biologics within the recommended temperature range, and to additional data that showed that only 11.6% of anti—tumor necrosis factor (anti-TNF) injectors were stored within recommended temperature ranges.

The newly granted update was based on a study, recently published in Advances in Therapy, that sought to evaluate whether the biosimilar, aged to its full shelf life of 36 months, could then be stored at room temperature for a period of 4 weeks.¹ These conditions, wrote the investigators, represent a worst-case scenario for medication storage in circumstances in which patients face long periods without continuous access to refrigeration.

The investigators used 3 different batches of 36-month aged Imraldi and stored the samples at room temperature for 4 weeks. They tested the samples at baseline and again at weeks 2 and 4, nothing that the color and clarity of the drug did not change over time, nor did the presence of visible particles. The pH of the product also remained stable.

High—molecular weight impurities did not increase, the total purity of the biosimilar remained at or above 95.0%, the degree of nonglycosylation of heavy antibody chains remained below 4.3% for 4 weeks, and there was no degradation of the monoclonal antibodies. The product’s biological activity remained stable over the 4-week period, as measured by competitive inhibition binding and TNF-alpha neutralization assays, say the investigators.

News of the label update, which could provide the biosimilar with an edge over its competition in European tenders for adalimumab, comes as Samsung Bioepis begins to dominate the European biosimilars market; IQVIA data show that the greatest percentage (37%) of patients who switched to biosimilar adalimumab from Humira transitioned to Imraldi. Additionally, in the United Kingdom, which was responsible for the most consumption of brand-name Humira in the European Union as of September 2018, Imraldi was awarded approximately 45% of the market in a national tender for the best-value adalimumab.

Reference

1. Park D, Yun J, Hwang SJ, Park SJ. Evaluation of physiochemical and biological stability of 36-months-aged SB5 (adalimumab biosimilar) for 4 weeks at room temperature [published online December 15, 2018]. Adv Ther. doi: 10.1007/s12325-018-0851-5.