FDA Approves First Biosimilar for Lucentis

Byooviz becomes the first FDA-approved ophthalmology biosimilar and the first FDA-approved biosimilar referencing Lucentis (ranibizumab), according to a statement from developers Samsung Bioepis and Biogen.

The news comes just 3 weeks after the biosimilar received marketing authorization from the European Commission.

The biosimilar was approved for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Ranibizumab products function as an inhibitor for vascular endothelial growth factor (VEGF) that can prevent vision loss in patients with retinal vascular disorders that cause irreversible blindness or visual impairments in adults.

"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," said Kyung-Ah Kim, senior vice president and development division leader at Samsung Bioepis.

Samsung Bioepis and Biogen entered a commercialization agreement for 2 ophthalmology biosimilars, including Byooviz, in November 2019 for the United States, the European Union, Canada, Australia, and Japan. The 2 companies, based in Incheon, Republic of Korea, and Cambridge, Massachusetts, respectively, are also developing an aflibercept biosimilar (SB15) referencing Eylea.

Under a global licensing agreement with Genentech, the maker of the originator product (Lucentis, Samsung Bioepis and Biogen will have liberty to market Byooviz starting in June 2022, before the expiration of Genentech’s applicable supplementary protection certificates (SPCs) in the United States and prior to the expiration of SPCs in other territories.

“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.

The approval was based on evidence from a randomized, double-masked, parallel group, multicenter phase 3 study assessing the safety, efficacy, pharmacokinetic, and immunogenicity profiles of Byooviz compared with Lucentis in patients with wet AMD.

In total, 705 patients were randomized 1:1 to receive either monthly 0.5-mg injections of the biosimilar or the reference product, and 634 patients continued to receive treatment up through week 48.

The least squares (LS) mean change in best corrected visual acuity from baseline at week 52 was 9.79 letters for the biosimilar and 10.41 letters for the reference product (–0.62; 95% CI, 2.092-0.857). The LS mean change in central subfield thickness was –139.55 mcm for Byooviz and –124.46 mcm for Lucentis (–15.09; 95% CI, –25.617 to –4.563).

Pharmacokinetic, safety regarding treatment-emergent adverse events, and immunogenicity profiles of the biosimilar were comparable with the reference product at all time points up to week 52.

Byooviz is the fifth Samsung Bioepis biosimilar to receive FDA approval, following the approvals of Renflexis (infliximab-abda; references Remicade) in April 2017, Ontruzant (trastuzumab-dttb; references Herceptin) in January 2019, Eticovo (etanercept-ykro; references Enbrel) in April 2019, and Hadlima (adalimumab-bwwd; references Humira) in July 2019.

Reference

FDA approves Samsung Bioepis and Biogen’s BYOOVIZ (SB11), LUCENTIS biosimilar (ranibizumab-nuna). News release. Samsung Bioepis. September 20, 2020. Accessed September 20, 2021. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=254&currentPage=1