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

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

Samsung Bioepis and Genentech Settles Patent Dispute of Trastuzumab Biosimilar-Ontruzant

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

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Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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