New Research Investigates Shelf Life, Device Usability of Biosimilar Adalimumab

Samsung Bioepis’ biosimilar adalimumab, SB5, has been approved in the European Union under the name Imraldi on the basis of clinical studies including a phase 3 study in patients with rheumatoid arthritis. Now that the biosimilar has begun to make its way to EU patients, investigators are publishing new data on other key facets of the product, including its shelf life and device usability.
Kelly Davio
January 16, 2019
Samsung Bioepis’ biosimilar adalimumab, SB5, has been approved in the European Union under the name Imraldi on the basis of clinical studies including a phase 3 study in patients with rheumatoid arthritis (RA). Now that the biosimilar has begun to make its way to EU patients, investigators are publishing new data on other key facets of the product, including its shelf life and device usability.

In a paper newly published in Advances in Therapy1, investigators explained that SB5 is currently approved for storage between 2 to 8 degrees Celsius for 36 months, and may be stored at room temperature for a maximum of 14 days. In their study, the investigators sought to evaluate whether SB5, aged to its full shelf life of 36 months, could then be stored at room temperature for a period of 4 weeks. These conditions, they say, represent a worst-case scenario for medication storage in circumstances in which patients face long period without continuous access to refrigeration.

The investigators used 3 different batches of 36-month aged SB5 and stored them at room temperature for 4 weeks. They tested the samples at baseline and again at week 2 and 4.

According to the investigators, 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 for the 4-week period.

High–molecular weight impurities did not increase, the total purity of SB5 remained at or above 95.0%, and the degree of nonglycosylation of heavy antibody chains remained below 4.3% for 4 weeks, indicating that there was no degradation of the monoclonal antibodies. SB5’s biological activity remained stable over the 4-week period, as measured by competitive inhibition binding and TNF-alpha neutralization assays. 

The paper’s authors conclude that SB5 remained stable and biologically active for 4 weeks at room temperature after aging to its shelf life, suggesting that the stability profile is 2 weeks longer than is currently approved in the European Union.

A separate investigation, published in Current Medical Research and Opinion2, sought to investigate a question that is key to patients who are being switched to a biosimilar: injection site pain and safety of injection with either a prefilled syringe or an autoinjector pen.

In the open-label study in 49 patients with RA, patients self-administered their 40-mg doses of adalimumab subcutaneously with a syringe at weeks 0 and 2 of the study, followed by an autoinjector at weeks 4 through 10. Patients rated their injection site pain from 0 (no pain) to 10 (severe pain) at weeks 0, 2, 4, and 6.

Mean injection site pain scores were equivalent between the prefilled syringe and autoinjector immediately after the injection (2.3 versus 2.0; 97.5% CI, −0.99-0.30) and 15 to 30 minutes after the injection (0.8 versus 0.7; 97.5% CI, −0.47-0.25). Patients reported that their overall impression of both devices was comparable, through their overall preference was for the autoinjector. Treatment-emergent adverse events (AEs) were all mild to moderate, and there were no serious AEs reported.

Overall, wrote the investigators, SB5 showed equivalent injection site pain and comparable safety when administered by either of the 2 injection devices.

Reference
1. Park D, Yun J, Hwang SJ, Park SJ. Evaluation of physicohemical 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.

2. Ghil J, Zielinska A, Lee Y. Usability and safety of SB5 (an adalimumab biosimilar) prefilled syringe and autoinjector in patients with rheumatoid arthritis [published online December 18, 2018]. Curr Med Res Opin. doi: 10.1080/03007995.2018.1560211.

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