Samsung Bioepis Initiates Recruitment of Patients in P-III Study for SB12 (biosimilar, eculizumab) to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH) in India

Shots:

• The P-III study involves assessing of SB12(600/900 mg, IV) vs Soliris (eculizumab, 600/900 mg, IV) in 50 patients with PNH, evaluating the efficacy, safety, immunogenicity and PK
• The primary outcome of the study is to measure hemolysis by lactate dehydrogenase @26wks. parallel comparison and @52wks. by crossover comparison, with its expected completion in Jul’2021
• SB12 is a biosimilar to Soliris targeted for paroxysmal nocturnal hemoglobinuria. Soliris is mAb, approved by the US FDA for treat atypical hemolytic uremic syndrome, myasthenia gravis and neuromyelitis optica spectrum disorder

Click here to read full press release/ article | Ref: Center for Biosimilars| Image: Signbox