Samsung Bioepis Announces Phase 3 Results of Soliris Similar

SB12, demonstrating clinical medical equivalence with original Eculizumab

Samsung Bioepis announced on the 13th that it has unveiled the results of phase 3 clinical trials of Soliris (Eculizumab) biosimilar SB12 through the EHA annual academic conference held in Austria from the 9th to the 12th.

 

SB12 is the seventh biosimilar developed by Samsung Bioepis.

 

It is the first blood disease treatment.

 

The original Soliris is a treatment for incurable rare diseases such as PNH and aHUS developed by Alexion in the U.S.

 

Last year, global sales amounted to $1.874 billion (approximately 2.3 trillion won).

 

Samsung Bioepis conducted a comparative study between SB12 and the original (ECU) in PNH patients from July 2019 to October 2021.

 

At this conference, the results were announced in the form of an e-poster.

 

Samsung Bioepis conducted clinical trials by comparing and evaluating efficacy, safety, pharmacology, and immunogenicity between the two products.

 

Among PNH patients who were first prescribed drugs, 50 patients aged 18 or older whose LDH level was measured to be 1.5 times or more of the normal ULN were randomly assigned.

 

Samsung Bioepis administered SB12 or original every week for the first four weeks, 900 mg at the fifth week, and 900 mg every two weeks during the subsequent maintenance period.

 

It then conducted research until 50 weeks while switching the two products at the 26th week.

 

The primary efficacy evaluation index for this clinical trial was set as the "LDH level at the 26th week of drug administration" and the "AUEC (Area Under Effect Curve) of the time-adjusted LDH from 14th to 26th weeks and 40th to 52nd weeks.

 

As a result of the study, 46 out of 50 patients completed clinical trials, and the primary efficacy evaluation index met the predefined clinical equivalence range.

 

The difference in mean LDH values at week 26 (SB12-ECU=34.48) between SB12 and the original drug was found to have a 95% confidence interval (-47.66, 116.62) in the predefined equivalence range.

 

For SB12/ECU: 1.08) between SB12 and the original drug, it was included in the predefined equivalence range in the 90% confidence interval (0.95, 1.23).

 

Similar results were found in the LDH values for the entire clinical trial period, one of the secondary efficacy evaluation indicators.

 

For TEAs, SB12 was 72.3% and original drugs were 68.1%.

 

All three serious post-treatment adverse events in SB12 prescribed patients were unrelated to treatment.

 

Oh Yoon-seok, executive director of PE (Product Evaluation), the clinical director of Samsung Bioepis, said, "SB12 is a product that has the essential meaning of biosimilar development to improve patient accessibility of ultra-high-priced bio-medicine." He said, "We confirmed safety and efficacy compared to original drugs through clinical trials." Soliris is an expensive biopharmaceutical that costs hundreds of millions of won a year for adult-based medication, and Samsung Bioepis provides SB12 free of charge for up to two years to domestic and foreign patients who participate in clinical trials.