Replies to post #247755 on Biotech Values

[jbog]

This will hurt in the long run whereas it will allow Roche free reign in the meantime. I'm somewhat surprised REGN would use a new CMC or the CMC is under a FDA hold program.

Now I see it's Catalent, Oh Boy .

[DewDiligence]

FDA approves high-dose—(8mg)—Eylea for AMD/DME:

https://www.globenewswire.com/news-release/2023/08/18/2728276/0/en/EYLEA-HD-aflibercept-Injection-8-mg-Approved-by-FDA-for-Treatment-of-Wet-Age-related-Macular-Degeneration-wAMD-Diabetic-Macular-Edema-DME-and-Diabetic-Retinopathy-DR.html

The main competition for high-dose Eylea will be Roche’s Vabysmo (#msg-171778214) and biosimilars for regular-dose (4mg) Eylea that will soon enter the market.