• SB15 demonstrates comparable efficacy, safety, immunogenicity, and pharmacokinetics profiles to reference aflibercept up to Week 56
• Switching group had similar efficacy and safety compared to the continuing groups without treatment-emergent issues such as loss of efficacy, increased adverse events, or increased immunogenicity
INCHEON, Korea – April 24, 2023 – Samsung Bioepis Co., Ltd. today announced that 1-year outcomes of the Phase 3 study for SB15, a proposed biosimilar to Eylea1 (aflibercept), were presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held from April 23 to 27, in New Orleans, Louisiana. In addition, new analytical data on similarity between SB15 and reference product in terms of structural and physicochemical properties and biological functions were also presented.
At the meeting, researchers presented 56-week results from the Phase 3 clinical study between SB15 and reference aflibercept (AFL) in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK). 32-week interim results from the same Phase 3 study were previously presented at the 2022 American Academy of Ophthalmology (AAO) Annual Meeting in September 2022.2
Out of the total 449 patients with neovascular age-related macular degeneration (nAMD), 438 patients were first randomized 1:1 to receive either SB15 or AFL. At Week 32, patients were re-randomized to either continue SB15 or AFL, or switch from AFL to SB15 resulting in three treatment groups; continuing SB15 (SB15/SB15, n=219), continuing AFL (AFL/AFL, n=108), switching from AFL to SB15 (AFL/SB15, n=111). In total, 425 patients completed up to Week 56.
Key efficacy endpoints of the study were 1) change from baseline in best corrected visual acuity (BCVA), 2) change from baseline in central subfield thickness (CST), and 3) proportion of patients with intra/sub-retinal fluid. Up to Week 56, improvements in BCVA were comparable between three treatment groups. In the switching group (AFL/SB15), least square (LS) mean change from baseline CST was well maintained and comparable to the continuing group (AFL/AFL). Safety, immunogenicity, and PK profiles of SB15 were also comparable with those of AFL, and no treatment-induced or treatment-boosted anti-drug antibodies (ADA) developed in the switching group (AFL/SB15) after Week 32.
In addition to the 56-week results from the Phase 3 study, new analytical data on similarity between SB15 and AFL in terms of structural and physicochemical properties and biological functions was presented at the meeting. Based on the comprehensive analytical similarity assessment, SB15 showed high similarity to AFL with respect to structural, physicochemical, and biological properties.
"The presentations showcase our ongoing commitment in ophthalmology to bring more access to treatments for patients suffering from retinal vascular diseases," said Jin-Ah Jung, Medical Affairs Group Leader, Samsung Bioepis. “Biosimilars are relatively new in ophthalmology compared to other therapeutic areas, and we will continue to advance with our scientific research, publication and educational activities to bring more awareness of biosimilars among ophthalmologists,” she added.
Samsung Bioepis and Biogen announced in November 2019 that they had entered into an exclusive commercialization agreement for two ophthalmology biosimilar candidates, SB11/BYOOVIZ™ (ranibizumab) and SB15 (aflibercept) in major markets around the world.
SB15, if approved, will strengthen the portfolio offerings of the two companies with two of the most widely prescribed anti-VEGF therapies, extending options for patients, prescribers while helping enable healthcare sustainability.
# # #
Details about Samsung Bioepis’s abstract are as follows:
Phase III Randomized Clinical Trial Comparing SB15 with Reference Aflibercept in Neovascular Age-Related Macular Degeneration
Session: Paper Session 119
Date/Time: Apr 23, 2023 1:00 PM-1:15 PM
Abstract Number: 3877747
Presentation Number: 464
Authors: SriniVas R. Sadda, Se Joon Woo, Mario Bradvica, Attila Vajas, Min Sagong, Jan Studnicka, Edward Wylegala, Cheolmin Yun, Michal Orski, Sergei Astakhov, Edit Tóth-Molnár, Adrienne Csutak, Lajos Enyedi, Taehyung Kim, Inkyung Oh, Hyerin Jang
Analytical Similarity Assessment of an Aflibercept Biosimilar SB15 to Its Commercially Available Reference Product (Eylea)
Session: Poster Session 256 (AMD antiVEGF)
Date/Time: April 24, 2023, 3:15 PM-5:00 PM
Abstract Number: 3879811
Posterboard Number: 2246 - C0199
Authors: Min Sagong, Hangyeore Lee, Jongcheol, Huh, Dayoung Kim, Soye Lee, Beomchan Kim, Jinsu Song, Jungmin Lee, Neil M Bressler
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com
and follow us on social media – Twitter
Anna Nayun Kim, email@example.com
Jane Chung, firstname.lastname@example.org
1 Eylea is a trademark of Regeneron.
2 Se Joon Woo, Srinivas R Saddam et al. SB15, a Proposed Biosimilar to Aflibercept, in Neovascular Age-Related Macular Degeneration (nAMD): 32-week Results. Abstract presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting.