Positive Phase III data released from biosimilar trial
The study aimed to determine clinical efficiency of a proposed biosimilar to Soliris
Samsung Bioepis has announced that SB12, a proposed biosimilar to Soliris (eculizumab), showed clinical equivalence in efficacy, safety, pharmacodynamics (PD), and pharmacokinetics (PK), in a Phase III trial.
The study is an ongoing randomised, doubleblind, multicenter, cross-over study in 50 patients to treatment sequence I or II.
Soliris (eculizumab) is a humanised monoclonal antibody, produced in NS0 cell line by recombinant DNA technology, currently used in adults and children for the treatment of PNH and atypical haemolytic uremic syndrome (aHUS). It is also used in adults for refractory generalised myasthenia gravis (gMG), in patients who are anti-acetylcholine receptor antibody-positive.
The objective of the study was to determine clinical efficacy by evaluating the level of lactate dehydrogenase (LDH), safety, PK, PD, and the immunogenicity of SB12 and reference eculizumab (ECU). The primary endpoints were LDH level at Week 26, and time-adjusted area of under the effect curve (AUEC) of LDH from Week 14 to 36, and from Week 40 to 52.
“We are very pleased to be sharing our Phase III study of SB12, our first haematology and orphan biologic therapy, at EHA 2022,” said Luke Oh, PhD, Vice President and Product Evaluation Team Leader at Samsung Bioepis. “We are fully aware that rare diseases, such as PNH, pose many unique challenges to patients and their families. We will continue our journey to transform the way biologic therapies are brought to and enhance the lives of patients, including those with rare diseases, through our pioneering and innovative use of science and technology.”