Samsung Bioepis "First Ophthalmic Disease Treatment, Proven Equivalent to Original"

[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis's biosimilar for eye disease patients, 'SB11,' has demonstrated clinical equivalence to the original drug in a global Phase 3 clinical trial. SB11 is Samsung Bioepis's first ophthalmic treatment.

On the 18th, Samsung Bioepis announced the comparative study results on the efficacy and safety of SB11 versus the original drug Lucentis.

Lucentis is an ophthalmic treatment for diseases such as macular degeneration and diabetic macular edema, jointly developed by Genentech, a subsidiary of multinational pharmaceutical company Roche, and Novartis. Its global sales reached approximately 4.6 trillion KRW last year.

Samsung Bioepis conducted clinical trials on 705 patients with wet age-related macular degeneration from March 2018 to December last year.

According to the study results, the least squares mean of maximum corrected visual acuity improvement at 8 weeks was 6.2 letters for SB11 and 7.0 letters for the original drug. The 90% confidence interval of the difference between the two met the pre-established equivalence margin.

The least squares mean change in central retinal thickness at 4 weeks was -108.4 micrometers (μm) for SB11 and -100.1 micrometers for the original drug. The 95% confidence interval of the difference between the two also met the pre-established equivalence margin.

A Samsung Bioepis official explained, "SB11 achieved the primary efficacy endpoint of the Phase 3 clinical trial for Lucentis biosimilar development, demonstrating clinical equivalence to the original drug."

Samsung Bioepis plans to apply for marketing approval of SB11 in the U.S. and Europe as early as this year, initiating the formal product approval process. In addition to SB11, Samsung Bioepis is developing the Eylea biosimilar 'SB15.' Through a follow-up partnership agreement with U.S. company Biogen in November last year, the company has early established marketing infrastructure in major global markets including the U.S. and Europe for both products.

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