By Kevin E. Noonan — The U.S. Food and Drug Administration approved the first biosimilar drug for treating macular degeneration under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as “Obamacare”). The drug is Byooviz (ranibizumab-nuna), a biosimilar to Genentech’s Lucentis®, and like Lucentis® has been approved for treating several eye diseases and conditions. Specifically, according to the FDA announcement, Byooviz is approved for “neovascular (wet) age-related macular degeneration (nAMD)[,] macular edema (fluid build-up) following retinal vein occlusion (blockage of…
