Replies to post #243734 on Biotech Values

[dewophile]

Whether these results are enough to materially cut into use of the coming Eylea biosimilars remains to be seen. I'm skeptical

agree re biosimilars
I do think this helps stave off some of the competition that has longer dosing intervals
REGN relies almost entirely on 2 drugs so I think it is a risky investment for a large cap. Their PD-1 is also going to be hampered by LOE of other PD-1s. The bifunctional pipeline in oncology looks good but will be entering an awfully competitive space w heavyweights like Roche PFE etc w similar offerings
REGN is up big today so obviously I don't agree w the market

[DewDiligence]

REGN—(-8%)—receives CRL for high-dose Eylea due_to_CMC_issues_at_fill/finish_contractor:

https://finance.yahoo.com/news/fda-issues-complete-response-letter-184500243.html

The CRL did not identify any issues with the aflibercept 8 mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials have been requested.

When it is eventually approved, the main competition for high-dose Eylea will be Roche’s Vabysmo (#msg-171778214) and Eylea biosimilars that will soon enter the market.