FDA Approves First Biosimilar Drug for Treatment of Wet AMD

The U.S. Food and Drug Administration (FDA) has approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of wet AMD. Byooviz is also approved to treat macular edema and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness). The drug is administered by intravitreal injection (delivered into the vitreous humor of the eye) once a month.

Biological products (i.e. Lucentis, Eylea, and Beovu) are generally derived from living organisms and can come from many sources 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.

An important benefit of biosimilars is that they are considerably less expensive. In the case of Byooviz, the savings over Lucentis could be as much as $100 billion in the US over the next 5 years. The FDA granted approval of Byooviz to Samsung Bioepis, and other companies are expected to soon enter the market of biosimilars.

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SOURCE: Press Release