• Profile
Close

Efficacy and safety of a proposed ranibizumab biosimilar product vs a reference ranibizumab product for patients with neovascular age-related macular degeneration: A randomized clinical trial

JAMA Ophthalmology Dec 14, 2020

Woo SJ, Veith M, Hamouz J, et al. - In this randomized, double-masked, parallel-group phase 3 equivalence study, researchers sought to demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11, a proposed ranibizumab biosimilar product, compared with the reference ranibizumab. The sample consisted of 705 participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years) 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions. According to findings, SB11 showed equivalence in efficacy for both primary endpoints: adjusted treatment differences between groups were within predefined equivalence margins for mean changes from baseline in both BCVA at week 8 and CST at week 4. The safety and immunogenicity profiles between SB11 and ranibizumab were identical. Such findings suggest that SB11 is comparable to its reference product, ranibizumab.

Go to Original
Only Doctors with an M3 India account can read this article. Sign up for free or login with your existing account.
4 reasons why Doctors love M3 India
  • Exclusive Write-ups & Webinars by KOLs

  • Nonloggedininfinity icon
    Daily Quiz by specialty
  • Nonloggedinlock icon
    Paid Market Research Surveys
  • Case discussions, News & Journals' summaries
Sign-up / Log In
x
M3 app logo
Choose easy access to M3 India from your mobile!


M3 instruc arrow
Add M3 India to your Home screen
Tap  Chrome menu  and select "Add to Home screen" to pin the M3 India App to your Home screen
Okay