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September 21, 2021 – Samsung Bioepis and Biogen's ByoovizTM (ranibizumab-nuna) has received U.S. FDA approval as a biosimilar for Genentech's Lucentis® (ranibizumab). It is the first biosimilar ophthalmology product approved for use in the United States.
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Myopic Choroidal Neovascularization (mCNV)
- Neovascular AMD: 0.5mg (0.05mL) administered by a healthcare provider via intravitreal injection once a month (approximately 28 days). Though less effective, patients can also be treated with three monthly doses, followed by less frequent dosing, or one dose every three months after four monthly doses.
- Macular Edema Following RVO: 0.5mg (0.05mL) administered by intravitreal injection once a month.
- mCNV: 0.5mg (0.05mL) initially administered by intravitreal injection once a month for up to three months. If needed, patients can receive retreatment.
Although Lucentis is approved to treat diabetic retinopathy and diabetic macular edema, Byooviz is not. In addition, while Lucentis is distributed in 6mg/mL and 10mg/mL solutions in single-use prefilled syringes and single-use glass vials, Byooviz will only be distributed in single-use glass vials as a 10mg/mL solution.
Like most biosimilars, Byooviz cannot be automatically interchanged with its reference product (Lucentis) by a pharmacist. A new prescription is required if a patient wishes to switch to Byooviz, which in some instances may cost the patient less out of pocket compared to Lucentis.
Samsung Bioepis and Biogen will begin marketing Byooviz in June 2022. Pricing is not yet available.