GLOBAL RESEARCH ARCHIVE
REGN: Takeaways from our LA/SF NDR
Research evidence excerpt
REGN: Takeaways from our LA/SF NDR
ng patents that
should be issued by the USPTO – REGN learned about the holes the LD Eylea biosimilars tried to navigate, and have written their new HD patents to
prevent biosimilars from taking the same argument route.
Although more Eylea biosimilars will enter the market starting 2H26, not all biosimilars enter w/ a prefilled syringe. REGN also thinks it’ll be•
interesting to watch what happens with Pavblu, as the rebate deferral is coming due. It could be possible that Pavblu's ASP spirals by 1Q27 due
to aggressive discounting (similar to Cimerli), leading it to be pulled from market due to unprofitability. Note the ASP in Q3 has already started
declining. The remaining Q is whether Pavblu pts then go to another biosimilar Eylea or to HD Eylea. For now, mgmt is focused on converting
as many Eylea pts to HD as possible.
c5 in GA: While there is no clinical data of their c5 assets in GA, REGN's conviction comes from its CH50 assay data, which measured the level of
complement in the blood after both combo and mono therapies. At 12 weeks and beyond, combo therapy eliminated over 99% c5 in the blood, while
monotherapy eliminated over 77% c5 in the blood. REGN's hypothesis is that GA is a complement-mediated disease and complement is not made in
the blood; rather, REGN believes complement is made in the liver and circulates through the eye. Thus, by eliminating complement in the liver with
the siRNA, and neutralizing any residual c5 in the blood with the antibody, the hope is that they would see a therapeutic effect in the eye.
REGN will get the first 225 pt data in the interim analysis exp in Q4'26. The data will evaluate the rate of growth of geographic lesion area for•
cemdisiran combo, monotherapy, and pbo at 24 weeks.
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