Samsung Bioepis Reports Results of SB11 (proposed biosimilar ranibizumab) in P-III Study for Neovascular Age-Related Macular Degeneration

 Samsung Bioepis Reports Results of SB11 (proposed biosimilar ranibizumab) in P-III Study for Neovascular Age-Related Macular Degeneration

Samsung Bioepis Reports FDA’s Acceptance of BLA for SB8 (biosimilar, bevacizumab)

Shots:

  •  The P-III study involves assessing of SB11 vs reference product, LUCENTIS in monthly injections (0.5mg) in 705 patients in a ratio (1:1) with nAMD
  • The P-III study results demonstrated equivalent efficacy in terms of change in BCVA @8wk. and CST @4wk., LS change in BCVA (6.2 vs 7.0 letters), LS change in CST ( −108.4μm vs −100.1μm), AEs (66.0% vs 66.9%). The data was to be presented at ARVO 2020 which has been cancelled due to COVID-19
  • Additionally, in Nov’2019, Samsung collaborated with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the US, Canada, EU, Japan, and Australia

Click here to read full press release/ article | Ref: Samsung Bioepis | Image: Samsung Bioepis

Related News: Samsung Bioepis Reports Results of Ontruzant (biosimilar, trastuzumab) in P-III Follow-up Study (SB3-G31-BC-E) for Early or Locally Advanced HER2-Positive Breast Cancer

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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