FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

FDA News Release

• For Immediate Release: September 17, 2021

The U.S. Food and Drug Administration today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss and blindness for Americans aged 65 years and older. Byooviz is also approved to treat macular edema (fluid build-up) following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).

“Today’s approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. “Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs.”

Neovascular (wet) age-related macular degeneration destroys the sharp, central vision needed to see clearly and can affect daily activities like reading, driving and watching television. There are two types of AMD—dry and wet. While dry AMD is more common, wet AMD leads to vision loss at a faster rate. Both macular edema and myopic choroidal neovascularization can also lead to visual impairment.

Biological products are generally derived from a living organism and can come from many sources, including animals and microorganisms, such as bacteria or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law. Patients can expect the same safety and effectiveness from the biosimilar over the course of treatment as from the reference product.

The FDA’s approval of Byooviz was based on a review of evidence that included extensive structural and functional characterization, comparative clinical efficacy and safety evaluations, including potential immunogenicity (type of immune response) that demonstrated Byooviz is biosimilar to Lucentis.

To date, the FDA has approved 31 biosimilars, including one interchangeable biosimilar, for the treatment of a variety of health conditions.

Byooviz is administered by intravitreal injection (delivered into the vitreous humor of the eye) once a month. Administration of Byooviz may cause serious side effects, including: endophthalmitis (infection inside the eye) and retinal detachments; increases in intraocular (inside the eye) pressure; and thromboembolic (obstruction of a blood vessel by a blood clot) events. The most common side effects of Byooviz include conjunctival hemorrhage (broken blood vessel), eye pain, vitreous floaters (black spots that drift across the eye) and increased intraocular fluid pressure.

The FDA granted approval of Byooviz to Samsung Bioepis.