Biotech Values

[DewDiligence]

PFE—FDA approves Ixifi—(RemicadeFoB)—but product will not be commercialized, according to PFE, because PFE/Celltrion already market the FDA-approved Remicade FoB, Inflectra, which was approved by the FDA in Apr 2016 (#msg-121701314):

https://finance.yahoo.com/news/fda-approves-pfizer-biosimilar-230100940.html

PFE has two Remicade FoBs because it already had one in development when it acquired HSP (#msg-110577169), who also had one in development. The programs were far enough along that PFE decided to keep both of them.

PFE will now presumably seek to out-license the rights to Ixifi.

The US market has a third Remicade FoB: Renflexis from MRK/Samsung, which was approved in Apr 2017 (#msg-130698123).

All told, the FDA has now approved 9 FoBs corresponding to 6 branded products (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580432.htm ).