Logo

Samsung Bioepis’s SB12, a Proposed Biosimilar to Soliris (eculizumab) Meet its 1EPs in P-I Study for Paroxysmal Nocturnal Haemoglobinuria

Share this
Samsung Bioepis’s SB12, a Proposed Biosimilar to Soliris (eculizumab) Meet its 1EPs in P-I Study for Paroxysmal Nocturnal Haemoglobinuria

Samsung Bioepis’s SB12, a Proposed Biosimilar to Soliris (eculizumab) Meet its 1EPs in P-I Study for Paroxysmal Nocturnal Haemoglobinuria

Shots:

  • The company reported the results from the P-I study to evaluate SB12 (300mg) vs eculizumab via IV infusion in a ratio (1:1:1) in 240 patients with PNH
  • The study met all 1EPs that showed PK equivalence and comparable PD profiles b/w SB12 and eculizumab. The 2EPs included AUClast and Cmax while safety profiles including immunogenicity were also comparable b/w SB12, EU-sourced eculizumab, and US-sourced eculizumab treatment groups & no death or discontinuation due to TEAEs were observed
  • Soliris is a humanized mAb that binds to the human C5 complement protein & is currently used for the treatment of PNH, aHUS, gMG, and NMOSD

Ref: Globe Newswire | Image: Samsung Bioepis

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Related News/Articles

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions