FDA Approves Byooviz as Interchangeable Lucentis Biosimilar

FDA has approved the supplemental biologics license application (sBLA) for Byooviz (ranibizumab-nuna) as a biosimilar interchangeable with Genentech’s Lucentis (ranibizumab).

Developed by Samsung Bioepis and marketed in the United States by Biogen, Byooviz was approved as the first biosimilar to Lucentis. It was approved to treat neovascular (wet) age-related macular degeneration, a leading cause of vision loss and blindness for Americans over the age of 65. It is also approved to treat macular edema following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).

“With this designation, Byooviz is now both biosimilar to and interchangeable with the reference product. confirming that there is no unexpected risk in terms of safety or diminished efficacy associated with switching between Byooviz and Lucentis," Byoung In Jung, vice president and regulatory affairs team leader at Samsung Bioepis, told Formulary Watch. "We will continue to reinforce our commitment to broadening access to life-enhancing biologic medicines by advancing our biosimilar pipeline for the benefit of patients, healthcare providers, and healthcare systems around the world.”

Byooviz launched in June 2022 with a list price of $1,130 per 0.05 mg single use vial to be administered by injection to the back of the eye. This is which is 40% lower than the current list price of Lucentis,

Although Byooviz was the first approved biosimilar to Lucentis, it is the second interchange product. The FDA in August 2022 approved Coherus’ Cimerli (ranibizumab-eqrn) as a biosimilar product interchangeable for all five indications, including age-related macular degeneration and diabetic retinopathy. Cimerli launched with a list price of $1,360 for the 0.5 mg dose single-use vial and $816 for the 0.3 mg dose vial.