Samsung Bioepis Presents Data from its Ophthalmology Biosimilar Portfolio at American Academy of Ophthalmology (AAO) 2022 Annual Meeting

• SB15, a proposed biosimilar to EYLEA, showed equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics profile to reference aflibercept in the Phase 3 study interim analysis
• A post-hoc analysis based on the Phase 3 study of SB11 (BYOOVIZ™, ranibizumab-nuna), a biosimilar to LUCENTIS, confirmed its low immunogenicity profile and no correlation was found between immunogenicity and clinical outcomes

INCHEON, Korea, Sept. 27, 2022 (GLOBE NEWSWIRE) — Samsung Bioepis Co., Ltd. today announced that three scientific abstracts relating to its ophthalmology biosimilar portfolio will be presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting being held from September 30 to October 3, 2022 in Chicago, United States.

The Phase 3 study on SB15, a biosimilar candidate referencing EYLEA (aflibercept), compared the efficacy, safety, immunogenicity, and pharmacokinetics (PK) of SB15 to reference aflibercept in neovascular age-related macular degeneration (nAMD). The primary endpoint was met in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, and the 32-week interim analysis demonstrated comparability in other secondary efficacy endpoints, safety, immunogenicity, and PK between SB15 and reference aflibercept.

A post-hoc analysis of the Phase 3 study on SB11, a biosimilar referencing LUCENTIS (ranibizumab), analyzed the association of immunogenicity with one-year results of SB11 in nAMD. The efficacy data were analyzed based on participants’ anti-drug antibodies (ADA) status through Week 52. Immunogenicity response (incidence of ADA) was low and not different between SB11 and reference ranibizumab. Immunogenicity did not seem to be associated with clinical outcomes in the study.

Another post-hoc analysis of the Phase 3 study on SB11 determined baseline factors associated with one-year efficacy outcomes in nAMD. Associations between baseline factors and treatment responses of BCVA and central subfield thickness (CST) at Week 52 were assessed by linear regression analyses and multivariable analysis on baseline factors judged relevant. The study found that baseline age, BCVA, and CST were determined to be predictive of visual acuity and anatomical outcomes when treating nAMD with SB11 or reference ranibizumab. Similar results were shown from post-hoc analysis of multiple clinical trials in nAMD, such as CATT, MARINA, and VIEW studies.^1,2,3 These similarities further support equivalent clinical efficacy between the products.

“We are delighted to share multiple data that demonstrate comparable clinical efficacy, safety, immunogenicity, and PK profile of our ophthalmology biosimilar portfolio at the AAO Annual Meeting. This is the first time to present a Phase 3 data for SB15, our aflibercept biosimilar candidate,” said Jin Ah Jung, Director and Medical Affairs Group Leader, Samsung Bioepis. “Along with SB15 data, it was important that we address immunogenicity profile of SB11, because as with any biologic therapies, immunogenicity is considered an important risk factor that can potentially affect clinical outcomes of treatment. We hope that our continued efforts for data generation help ophthalmologists have better understanding of biosimilars, and their comparable efficacy, safety, immunogenicity, and PK profile to reference products,” she added.

Details about Samsung Bioepis’s presentations are as follows:

In the US, SB11 was approved by the U.S. Food and Drug Administration (FDA) in September 2021 under the brand name BYOOVIZ (ranibizumab-nuna) as the first ophthalmology biosimilar in the US.⁴ BYOOVIZ became commercially available in July 2022, marking the first biosimilar launch in the US under Samsung Bioepis and Biogen’s partnership.

Samsung Bioepis and Biogen entered into a commercialization agreement for two ophthalmology biosimilars, SB11 (ranibizumab) and SB15 (aflibercept) in November 2019. In addition to the FDA approval, SB11 was also approved by the European Commission (EC) and by the Medicines and Healthcare products Regulatory Agency (MHRA) in August 2021, by Health Canada in March 2022, and by the Therapeutic Good Administration (TGA) in August 2022 under the brand name BYOOVIZ.

About BYOOVIZ (ranibizumab-nuna)

BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use.

BYOOVIZ (ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection).

BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:

Neovascular (Wet) Age-Related Macular Degeneration (AMD)

Macular Edema Following Retinal Vein Occlusion (RVO)

Myopic Choroidal Neovascularization (mCNV)

Select Important Safety Information

WARNING AND PRECAUTIONS

Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection. Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

ADVERSE REACTIONS

The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP. For additional safety information, please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE.

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 biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

MEDIA CONTACT

Anna Kim, [email protected]

Yoon Kim, [email protected]

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1 Ying GS, Maguire MG, Daniel E, et al. Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group. Association of Baseline Characteristics and Early Vision Response with 2-Year Vision Outcomes in the Comparison of AMD Treatments Trials (CATT). Ophthalmology. 2015 Dec;122(12):2523-31.e1. doi: 10.1016 /j.ophtha.2015.08.015. Epub 2015 Sep 15. PMID: 26383996; PMCID: PMC4658285.

2 Boyer DS, Antoszyk AN, Awh CC, et al. MARINA Study Group. Subgroup analysis of the MARINA study of ranibizumab in neovascular age-related macular degeneration. Ophthalmology. 2007 Feb;114(2):246-52. doi: 10.1016/j.ophtha. 2006.10.045. PMID: 17270674.

3 Steinle NC, Du W, Gibson A, et al. Outcomes by Baseline Choroidal Neovascularization Features in Age-Related Macular Degeneration: A Post Hoc Analysis of the VIEW Studies. Ophthalmol Retina. 2021 Feb;5(2):141-150. doi: 10.1016/j.oret.2020.07.003. Epub 2020 Jul 9. PMID: 32652314.

4 The U.S. Food and Drug Administration News Release. FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions. September 17, 2021. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-macular-degeneration-disease-and-other-eye-conditions. Accessed August 2022.