- Final 56-week results from the Phase 3 study for SB15 compared with reference aflibercept in neovascular age-related macular degeneration to be presented, in addition to analytical similarity data between SB15 and reference aflibercept
INCHEON, Korea, April 20, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that it will present new data on SB15, a proposed biosimilar to Eylea1 (aflibercept), at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held from April 23 to 27, in New Orleans, Louisiana.
At the meeting, researchers will present new analytical data on similarity between SB15 and reference product in terms of structural and physicochemical properties and biological functions, as well as 56-week results from the Phase 3 randomized clinical study between SB15 and the reference product in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK). 32-week interim results from the Phase 3 study were previously presented at the 2022 American Academy of Ophthalmology (AAO) Annual Meeting in September 2022.2
Details about Samsung Bioepis’s abstract are as follows:
| Abstract | Presentation Details |
| 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 |
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.
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, LinkedIn.
MEDIA CONTACT
Anna Nayun Kim, nayun86.kim@samsung.com
Jane Chung, ejane.chung@samsung.com
References:
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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.
