AAO Spokesperson: FDA Approval of Byooviz, First Biosimilar to Lucentis, Is “Significant"

The FDAapproval of the first biosimilar to Roche’s blockbuster drug Lucentis for neovascular (wet) age-related macular degeneration (AMD) and other eye diseases is definitely significant, according to George A. Williams, M.D., a clinical spokesperson for the American Academy of Ophthalmology.

The biosimilar, Byooviz (ranibizumab-nuna), was approved by the FDA last month as a treatment of AMD, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Byooviz’s approval is “significant” because it is the first FDA-approved biosimilar for an ophthalmic indication, and “it’s a biosimilar for one of the most popular and effective therapies we have in the ophthalmic space,” noted Williams in a recent interview Managed Healthcare Executive.® Williams, a retina specialist and former president of the American Academy of Ophthalmology, is chair of the department of ophthalmology and director of the Beaumont Eye Institute at Beaumont Health in Royal Oak, Michigan.

Byooviz is the first ophthalmology biosimilar approved in the U.S, but it won’t be available in the U.S. till June 2022 because of a global licensing agreement with Genentech, which is part of Roche. The Lucentis biosimilar was developed by Samsung Bioepis, a Korean company but will be marketed by Biogen in the U.S. as Byooviz.

The approval and marketing Byooviz is expected to cut into the U.S. sales of Lucentis, which came to $363 million in the U.S. in the second quarter of 2021.

Before Lucentis was approved in 2006, 90% of people who developed wet AMD would be legally blind within one year, Williams noted. "This therapy completely reversed that. Now, less than 10% of people with wet AMD will end up legally blind if starting appropriate treatments.”

“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, in a press release issued jointly by the Korean company and Biogen

About 11 million Americans live with AMD and the prevalence of advanced AMD is increasing because of the aging U.S. population, noted the Samsung Bioepis and Biogen.

“Biosimilars could help broaden patient access to more affordable treatments and generate health care savings to offset rising costs of these complex diseases while ensuring sustainability of healthcare systems,” Ian Henshaw, senior vice president and global head of Biosimilars at Biogen, said in a press release when the approval was announced.

However, pricing of the new biosimilar is unclear. The exact cost savings will be an important factor in whether the biosimilar gains acceptance and becomes commonly prescribed, Williams said.

“As physicians, the American Academy of Ophthalmology has always believed that more treatments options that benefit patients out there is a good thing. We’re fortunate to have three FDA-approved and one off-label anti-VEGF available and it will take some time to sort out how this biosimilar will benefit patients,” Williams added.

European and British drug regulators approved Byooviz in August.

The FDA has approved four other biosimilars developed by Samsung Bioepis: Renflexis (infliximab-abda), Ontruzant (trastuzumab-dttb), Eticovo (etanercept-ykro) and Hadlima (adalimumab-bwwd).