FDA Approves Byooviz, First Ophthalmology Biosimilar in U.S.

Today's Featured Story FDA Approves Byooviz, First Ophthalmology Biosimilar in U.S. by Angela Maas The FDA approval of the first biosimilar for ocular use is poised to bring savings to a costly class, particularly in Medicare. However, ophthalmologists' and retinologists' lack of experience with biosimilars is a potential roadblock to these drugs' uptake. Milestone in biosimilar landscape: On Sept. 20, the FDA approved Samsung Bioepis Co., Ltd. and Biogen Inc.'s Byooviz (ranibizumab-nuna) for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). The drug is a biosimilar of Roche Group unit Genentech USA, Inc.'s Lucentis (ranibizumab). "[Regeneron Pharmaceuticals, Inc.'s] Eylea (aflibercept) dominates the branded products in market share, and Lucentis is the second most highly utilized FDA-approved ophthalmic VEGF [vascular endothelial growth factor] inhibitor," says Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth. "Avastin, used off-label for ophthalmic indications, represents the third most highly utilized VEGF inhibitor most likely due to its very low cost (about $200 per year)." "The impact and uptake of Byooviz will be directly related to the cost at which this biosimilar enters the market," maintains Renee Rayburg, R.Ph., vice president of specialty clinical consulting at Pharmaceutical Strategies Group, who adds that biosimilars generally come onto the U.S. market at a discount of 10% to 30% off the reference product’s price. Some factors could slow uptake: A few factors could impact Byooviz's uptake in the U.S. One is that "the dosing interval for Byooviz is more frequent at four to six weeks, compared to Eylea at eight to 12 weeks and potential candidates in the pipeline such as Lucentis PDS [i.e., port delivery system] at six months and [Roche's] faricimab at up to 16 weeks," explains Rachel K. Anderson, Pharm.D., C.S.P., clinical program manager at AllianceRx Walgreens Prime. In addition, Byooviz has approval for only three of Lucentis' five FDA-approved indications. It was not approved for diabetic retinopathy and diabetic macular edema. Ultimately, says Mesfin Tegenu, R.Ph., CEO of RxParadigm, uptake of the biosimilar "would probably be more dependent on whether the products are covered by the payer or if there is a preferred or nonpreferred status." Perhaps most importantly, ophthalmologists have not had experience with biosimilars, which also could hamper the drugs' use. Payers have time, though, ahead of Byooviz's potential June 2022 launch, to address this issue. From RADAR on Specialty Pharmacy Subscribers may read the in-depth article online. Learn more about subscribing to AIS Health's publications.