Biotech Values

[DewDiligence]

(JNJ)—FDA approves Inflectra—a Remicade FoB from PFE/Celltrion:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm

Remicade is JNJ’s largest-selling drug in the US market. The Inflectra label includes all of Remicade’s labeled indications, but Inflectra is not interchangeable for Remicade at the pharmacy level.

Celltrion inked an FoB collaboration with Hospira in 2009 (#msg-42334655), and PFE inherited the collaboration when it acquired HSP in 2015. There are eight FoBs in this collaboration (#msg-84519981).

Inflectra is the second drug approved by the FDA under the 351(k) pathway for FoBs. (The first 351(k) was NVS’ Zarzio; like Inflectra, Zarzio was approved for all indications of the reference drug—AMGN’s Neupogen: #msg-111475426.)