Re­gen­eron, Bay­er's Eylea nabs six months of pe­di­atric ex­clu­siv­i­ty as com­pe­ti­tion waits to en­ter the mar­ket

Re­gen­eron and Bay­er’s block­buster eye drug Eylea has been giv­en six months more pro­tec­tion from com­pe­ti­tion — now ex­tend­ing in­to the first half of 2024.

The FDA grant­ed the block­buster VEGF in­hibitor pe­di­atric ex­clu­siv­i­ty for the next six months on Fri­day — send­ing the time­line for biosim­i­lar mar­ket en­try to May 17, 2024. Ex­clu­siv­i­ty for Re­gen­eron’s in­jec­tion was sup­posed to run out in late 2023.

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