Samsung Bioepis "Aflibercept Biosimilar Confirms Equivalence in Phase 3 Clinical Trial"

Samsung Bioepis announced on the 25th that it revealed the final Phase 3 clinical data of 'SB15' (active ingredient Aflibercept), a biosimilar of the macular disease treatment drug Eylea, at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) held in New Orleans, USA, from the 23rd to the 27th.

Samsung Bioepis headquarters exterior. [Photo by Samsung Bioepis]

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Samsung Bioepis conducted a Phase 3 clinical trial from June 2020 to March 2022 involving 449 patients with neovascular age-related macular degeneration (nAMD) across 10 countries including the United States and South Korea. Through this, the efficacy, safety, and immunogenicity between SB15 and the original drug were compared.

According to the abstract submitted by Samsung Bioepis, the best corrected visual acuity (BCVA) of the clinical trial patients improved similarly between SB15 and the original drug up to 56 weeks. Furthermore, the efficacy, safety, immunogenicity, and pharmacokinetic characteristics between SB15 and the original drug were similar up to 56 weeks. The group that switched from the original drug to SB15 after 32 weeks and the group that maintained the original drug administration also showed similar results in efficacy, safety, and immunogenicity up to 56 weeks.

Previously, the interim results of the Phase 3 clinical trial of SB15 presented by the company at the 2022 American Academy of Ophthalmology (AAO) showed that the primary efficacy endpoint, the best corrected visual acuity at 8 weeks, improved by 6.7 letters for SB15 and 6.6 letters for the original drug. The difference between the two groups met the pre-defined equivalence criteria.

A Samsung Bioepis representative stated, "We have once again demonstrated our research and development capabilities in ophthalmic disease treatments," adding, "We will continue to strive to improve patient access to high-quality biopharmaceuticals."

Eylea is an ophthalmic disease treatment drug developed by the American pharmaceutical company Regeneron, indicated for macular degeneration and diabetic macular edema. Its global sales reached $9.6474 billion (approximately 12 trillion KRW) last year.

SB15 is Samsung Bioepis’s eighth biosimilar pipeline and the second ophthalmic disease treatment following SB11 (Lucentis) biosimilar 'Amelibu' (active ingredient Ranibizumab). SB11 was launched starting in June 2022 in the United States, followed by South Korea, Germany, and Canada, expanding sales into the global market.

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