Samsung Bioepis Presents Data from its Ophthalmology Biosimilar Portfolio at AAO 2022 Annual Meeting

Samsung Bioepis 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.

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 wet age-related macular degeneration (AMD). 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 1-year results of SB11 in wet AMD. 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 1-year efficacy outcomes in wet AMD. 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 wet AMD with SB11 or reference ranibizumab. Similar results were shown from post-hoc analysis of multiple clinical trials in wet AMD, such as CATT, MARINA, and VIEW studies. 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,” Jin Ah Jung, Director and Medical Affairs Group Leader, Samsung Bioepis, said in a company news release. “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 FDA in September 2021 under the brand name Byooviz (ranibizumab-nuna) as the first ophthalmology biosimilar in the US. 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.