Samsung Bioepis Presents Clinical Results of Ophthalmic Disease Treatment 'SB11' at Domestic Conference for the First Time

Lucentis Biosimilar... Equivalence Confirmed
Obtained Sales Approval in Europe, USA, and Korea
"An Opportunity to Promote Efficacy and Safety Domestically"

Samsung Bioepis new headquarters exterior view.

[Asia Economy Reporter Lee Gwan-ju] Samsung Bioepis announced on the 11th at the online '2022 Korean Retina Society Summer Conference' that it presented the Phase 3 clinical trial results of the Lucentis biosimilar SB112 (generic name ranibizumab) and confirmed its equivalence to the original drug.

Samsung Bioepis conducted a global Phase 3 clinical trial targeting patients with neovascular age-related macular degeneration (nAMD). At this conference, data from 634 patients who continued treatment for 52 weeks out of 705 patients who participated in the clinical trial were presented.

The primary endpoint measured changes in best corrected visual acuity (BCVA) over 8 weeks and central subfield thickness (CST) over 4 weeks after drug administration. The clinical results met the pre-established equivalence margins for both measures.

Additionally, for the secondary endpoints, there were no differences in changes in BCVA and CST up to 52 weeks after drug administration, and safety, pharmacokinetic characteristics, and immunogenicity were found to be equivalent.

Samsung Bioepis SB11 US sales product Byoviz.

Professor Woo Se-jun of Bundang Seoul National University Hospital, who presented the results, explained, "The clinical trial confirmed equivalence between SB11 and the original drug in terms of efficacy, safety, immunogenicity, and pharmacokinetics, which enabled approval in the US, Europe, and other regions."

Lucentis, sold by Roche and Novartis, is a blockbuster biopharmaceutical for ophthalmic diseases such as neovascular age-related macular degeneration and diabetic macular edema, with sales reaching 4.4 trillion KRW last year.

Samsung Bioepis obtained the first approval to sell the Lucentis biosimilar under the trade name Amelibu in Europe and the US in August and September last year, respectively, and in Korea in May this year. Although SB11 clinical results were previously presented at the American Academy of Ophthalmology (AAO 2020), this is the first presentation in Korea through this conference.

A Samsung Bioepis official stated, "This presentation provided an opportunity to inform the domestic market about the efficacy and safety of SB11, and we expect to offer treatment benefits to more patients."

This content was produced with the assistance of AI translation services.