Samsung Bioepis Co and Biogen announced that the U.S. Food and Drug Administration (FDA) has approved BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy that prevents vision loss in patients with retinal vascular disorders which can cause irreversible blindness or visual impairments in adults in the United States (U.S.)

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, with the advantage that they offer cost savings and promote sustainable access to therapies.  Savings in the United States over the next five years from 2020 to 2024 as a result of biosimilars are projected to exceed $100 billion. 

"In the United States, approximately 11 million people are affected with AMD and the prevalence of advanced AMD is growing due to the ageing population. The approval of the first ranibizumab biosimilar in the U.S. is a monumental milestone for people living with retinal vascular disorders in the U.S.," said Kyung-Ah Kim, Senior Vice President and Development Division Leader, at Samsung Bioepis. “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,” she added.

“We are very excited to be able to open a new chapter with the approval of BYOOVIZ in the U.S. 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 U.S.,” 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 the sustainability of healthcare systems.”

In addition to the U.S. 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. According to a global license agreement entered into with Genentech, Samsung Bioepis and Biogen will have the freedom to market SB11 in the United States as of June 2022, i.e., before expiration of Genentech’s applicable supplementary protection certificates (SPCs), and elsewhere in other territories after expiration of Genentech’s SPCs.

BYOOVIZ (ranibizumab-nuna) is Samsung Bioepis’ fifth biosimilar approved in the U.S., 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.