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

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Samsung Bioepis

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

Shots:

  • The long-term follow-up results from the P-III equivalence study evaluating SB11 vs Lucentis which showed the similarity in efficacy EPs reported early on was maintained through 52wks.
  • The results also showed improvements in visual outcomes remained stable through 52wks. The safety profile was consistent with the known profile with no new safety concerns, 2% vs 1.1% experienced ocular TEAEs leading to the discontinuation of the study treatment
  • Cumulative incidence of ADAs over the 52wk. study was 4.2% vs 5.5%, no significant differences in the incidences of ADAs or neutralizing Ab b/w groups were reported, PK analysis of 54 patients showed comparable mean serum concentrations and PK profiles

Ref: Centerforbiosimilar | Image: Samsung Bioepis

Related News:- Samsung Bioepis Presents Two P-III Studies Results of SB11 (biosimilar, ranibizumab) for Neovascular Age-Related Macular Degeneration at AAO 2022

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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