Korean biosimilars are threatening original drugs with improved competitiveness in Europe, industry officials said.

Samsung Bioepis and Celltrion have demonstrated enhanced real-world data for their biosimilar products and promoted biosimilars with better patient convenience at the 2019 European League against Rheumatism (EULAR), held in Madrid, Spain, from Wednesday to Saturday.

At the event, Samsung Bioepis introduced Imraldi (ingredient: adalimumab), which has extended shelf life up to 28 days. Its reference drug Humira has 14 days of shelf life.

Samsung Bioepis said it found during Imraldi development that protein concentration and clarity of the drug remained stable within 25 degrees Celsius even when it extended the storage period to 28 days.

The European Medicines Agency (EMA) recently approved Imraldi’s changed label to indicate that it can be preserved at room temperature for 28 days.

The biosimilar product of Samsung Bioepis is the only one with doubled shelf life among authorized adalimumab products in Europe. The company hopes that European patients will find it easier to take Imraldi than other drugs.

According to a study on Dutch patients with rheumatism, only 6.7 percent of them stored their drugs according to the medication label. Such wrong drug storage could affect the lifespan of drugs.

Park Sang-jin, chief operating officer of Samsung Bioepis, said Imraldi’s winning of the nod to extend the shelf life proved the company’s R&D capabilities.

The company also presented therapeutic effects of biosimilar switching cases and comparisons with original drugs, based on real-world data of three autoimmune disease biosimilar treatments Benepali, Flixabi, and Imraldi.

According to the results of the study, there was no significant difference in Disease Activity Score-28 (DAS28) in 533 patients with rheumatoid arthritis (RA) and axial spondyloarthritis six months after they switched from the original drug (Enbrel) to Benepali (etanercept).

Additionally, according to the pooled analysis on 1,461 patients prescribed with etanercept, infliximab, and adalimumab, the biosimilar products showed similar outcomes with original drugs in DAS28, simplified disease activity index (SDAI), and disease fluctuation of CDAI at six months and one year of treatment.

Celltrion is pinning hopes on Remsima SC, the subcutaneous (SC) version of infliximab biosimilar.

An intravenous injection (IV) works quickly, but it takes more than two hours to administer, and the patient should visit the hospital every time. Unlike the existing Remsima IV, Remsima SC can be administered by patients themselves at home.

Celltrion released the phase-3 trial results for Remsima SC at the 2019 EULAR.

The study on 362 patients aimed to demonstrate the non-inferiority of Remsima SC in safety and efficacy, compared to Remsima IV.

The results showed that average changes in DAS28 were similar between the two groups from baseline to 22nd week of treatment. The efficacy, including ACR response, was similar, too, until 22 weeks, but Remsima SC group had a higher ACR response in the 30th week. Until the sixth week after the administration, the two medications showed similar safety profiles.

Once Celltrion wins approval for Remsima SC from the EMA, the company hopes to carve out a larger share in the autoimmune disease market with both Remsima IV and Remsima SC. Remsima is the only drug among etanercept, infliximab, and adalimumab class drugs to secure both IV and SC forms so that patients can choose the type according to their health status.

Original drugs with the SC form such as Humira and Enbrel are leading the TNF-α inhibitor market, including treatments for inflammatory bowel disease. In this market, Remsima can become a dark horse.

“We will grow Remsima SC, an affordable drug without various medical expenses, as a global blockbuster to beat the world’s leading drug Humira,” said Lee Sang-joon, senior vice president of Celltrion.