Byooviz™ has begun shipping

Under a settlement agreement, Biogen and Samsung Bioepis have begun shipping the first U.S. biosimilar to Genentech’s Lucentis® (ranibizumab). Beginning on July 1, 2022, Byooviz™ (ranibizumab-nuna) will be available to treat three serious conditions – neovascular (wet) age-related macular degeneration (nAMD), macular edema resulting from retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). Doses are administered by an ophthalmologist as 0.5mg injections directly into the affected eyes once a month. After monthly injections for three or four months, some patients may be able to receive Byooviz shots at longer intervals, such as once every three months, but outcomes may not be as good. The wholesale acquisition cost (WAC) for one vial is $1,130, which is about 60% of the cost for Lucentis. The two products are not interchangeable. For calendar year 2021, U.S. sales of Lucentis amounted to nearly $1.5 billion.

At a Glance

• Brand (Generic) Name: Byooviz (ranibizumab-nuna)
• Biosimilar to: Lucentis (ranibizumab)
• Manufacturer: Biogen and Samsung Bioepis
• Date Approved: Sept. 17, 2021
• Date of Launch: July 1, 2022
• Indication: to treat nAMD, macular edema resulting from RVO and mCNV
• Dosage Forms Available: Single-dose vials, each containing 0.3mg/0.05mL of ranibizumab for intravitreal injection
• Estimated Annual Cost: WAC for Byooviz is $1,130 per vial. Annual cost will depend on whether or not both eyes are affected and the spacing of doses
• The conditions that Byooviz treats primarily affect older patients.
• An estimated 1.1 million Americans have nAMD, which distorts central vision. It is caused by abnormal growth of blood vessels in the macula, the parts of the retinas responsible for clear central vision. Roughly 40% of cases involve both eyes at diagnosis, but up to 20% of patients progress to bilateral involvement each year.
• Macular edema resulting from RVO and mCNV are much less common than nAMD, but all three conditions can severely affect vision and, possibly, result in blindness.
• By blocking vascular endothelial growth factor (VEGF), ranibizumab decreases formation of and seepage from blood vessels in the eyes.
• In a head-to-head clinical trial between Byooviz and Lucentis, patients in both treatment groups had comparable results.
• Injections into the eyes may cause inflammation, irritation or increased intraocular pressure (IOP) for a small number of patients.
• Other VEGF inhibitors available in the U.S. for the treatment of some or all of the eye conditions that Byooviz treats include Eylea® (aflibercept), Macugen® (pegaptanib) and Vabysmo™ (faricimab-svoa). Avastin® (bevacizumab/biosimilars) is used off label.