FDA Approves Byooviz as Interchangeable Lucentis Biosimilar
Byooviz was approved as the first biosimilar to Lucentis and launched with a list price of $1,130 per single-use vial.
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.
Briana Contreras, editor of Managed Healthcare Executive, spoke with Nancy Lurker, CEO and president of EyePoint Pharmaceuticals. Nancy shared a bit about EyePoint and how the organization’s innovative therapies are addressing patient needs through eye care, and most importantly, she addressed C-Suite positions like the CEO role. Nancy shared advice for those seeking to reach the CEO level, especially toward women in healthcare and other roles, and what it takes to run a biopharma company.
Listen
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
