First Ophthalmology Biosimilar Approved in the United States
Samsung Bioepis and Biogen announced that the FDA has approved Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab)i, for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).
Byooviz is the first ophthalmology biosimilar approved in the United States. Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s reference product.
"In the United States, approximately 11 million people are affected with AMD and the prevalence of advanced AMD is growing due to the aging population. The approval of the first ranibizumab biosimilar in the US is a monumental milestone for people living with retinal vascular disorders in the US," Kyung-Ah Kim, Senior Vice President and Development Division Leader, at Samsung Bioepis, said in a company news release. “The approval of Byooviz underscores our continued commitment to providing valuable treatment options for people who do not have access to life-enhancing biologic medicines around the world."
“We are very excited to be able to open a new chapter with the approval of Byooviz in the US. This approval represents a great step toward the advancement of a new therapeutic option addressing debilitating disease progression of patients with retinal vascular disorders in the US,” said Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen. “Biosimilars could help broaden patient access to more affordable treatments and generate healthcare savings to offset rising costs of these complex diseases while ensuring sustainability of healthcare systems.”
In addition to the US approval, Byooviz was approved in Europe, including 27 European Union (EU) member countries, on August 18, 2021, and the United Kingdom on August 31, 2021.
Samsung Bioepis and Biogen entered into a commercialization agreement for two ophthalmology biosimilar candidates, SB11, a biosimilar candidate referencing Lucentis (ranibizumab), and SB15, a biosimilar candidate referencing Eylea (aflibercept), in November 2019. Developed by Samsung Bioepis, SB11 will be commercialized under the brand name Byooviz by Biogen in the United States. Pursuant to a global license agreement entered into with Genentech, Samsung Bioepis and Biogen will have freedom to market SB11 in the United States as of June 2022, i.e., before expiration of Genentech’s applicable SPCs, and elsewhere in other territories after expiration of Genentech’s SPCs.
The FDA approval of Byooviz was based on a totality of evidence including analytical, nonclinical data, and clinical data. In a randomized, double-masked, parallel group, multicenter phase 3 study of SB11, the efficacy, safety, pharmacokinetics, and immunogenicity of SB11 was compared to reference ranibizumab in patients with wet AMD. In the study, 705 patients were randomized (1:1) to receive SB11 or reference ranibizumab in monthly injections (0.5 mg), and 634 patients continued to receive treatment up to week 48. The Least Squares (LS) mean change in best corrected visual acuity (BCVA) from baseline at week 52 was 9.79 letters for SB11, compared with 10.41 letters for reference ranibizumab (difference: -0.62, [90% CI: -2.092, 0.857]). The LS mean change in central subfield thickness (CST) was −139.55 μm for SB11 vs −124.46 μm for reference ranibizumab (difference: -15.09, [95% CI, -25.617, -4.563]). PK, safety including incidence of treatment-emergent adverse events, and the immunogenicity profile of SB11 and reference ranibizumab were comparable at all timepoints up to week 52.
Byooviz (ranibizumab-nuna) is Samsung Bioepis’ fifth biosimilar approved in the US, following the approval of Renflexis (infliximab-abda) in April 2017, Ontruzant (trastuzumab-dttb) in January 2019, Eticovo(etanercept-ykro) in April 2019, and Hadlima (adalimumab-bwwd) in July 2019.