Samsung Bioepis "Confirmed Equivalence with Original in Phase 3 Clinical Trial for Ophthalmic Disease Treatment"

[Asia Economy Reporter Seo So-jung] Samsung Bioepis (CEO Go Han-seung) announced on the 12th that its biosimilar for ophthalmic disease treatment has confirmed equivalence to the original drug in Phase 3 clinical trials.

Samsung Bioepis will reveal the final Phase 3 clinical trial results of the ophthalmic disease treatment biosimilar 'SB11' through a poster presentation at the American Academy of Ophthalmology (AAO) Annual Meeting, held virtually from the 13th to the 15th.

SB11 is Samsung Bioepis's sixth biosimilar product, following three autoimmune disease treatments (SB2, SB4, SB5) and two oncology treatments (SB3, SB8), and is the company's first ophthalmic disease treatment biosimilar.

The original drug for SB11, 'Lucentis,' is an ophthalmic disease treatment for conditions such as macular degeneration and diabetic macular edema, marketed by multinational pharmaceutical companies Roche and Novartis, with annual global sales reaching approximately 4.6 trillion KRW.

From March 2018 to December last year, Samsung Bioepis conducted a global Phase 3 clinical trial comparing SB11 and the original drug on a total of 705 patients with wet (neovascular) age-related macular degeneration.

Based on this, Samsung Bioepis disclosed the initial 24-week interim analysis results in May, and the recently announced data represent the final analysis after one year of data collection.

According to the abstract released on the 11th (local time) via the host platform, Samsung Bioepis analyzed data from 634 patients who maintained prescriptions for 52 weeks out of the 705 participants, confirming equivalence between SB11 and the original drug in terms of drug efficacy, pharmacokinetics, immunogenicity, and safety.

Samsung Bioepis measured the maximum corrected visual acuity over 8 weeks and changes in central macular thickness over 4 weeks as primary efficacy endpoints, both of which met the pre-established equivalence margins in the clinical trial results.

Kim Hee-kyung, Executive Director of Clinical Medicine at Samsung Bioepis, stated, “Through the announcement of these research results, we were able to reaffirm the efficacy and safety of SB11, and we expect that SB11, our first ophthalmic disease treatment, will provide excellent therapeutic benefits to patients in the future.”

SB11 began the European Medicines Agency (EMA) marketing authorization application review process in October this year, becoming the first Lucentis biosimilar to do so in the European market, and Samsung Bioepis plans to proceed with the sales approval process in the U.S. market as well.

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