Replies to post #188457 on Biotech Values

[genisi]

I'm sure we'll see a long 'patent dance' with appeals process to the US PTO and up to the Federal Circuit, which could last several years...

[DewDiligence]

(PFE/Celltrion)—FDA advisory committee endorses Remicade FoB by 21-3 vote:

http://finance.yahoo.com/news/fda-arthritis-advisory-committee-recommends-225900284.html

INCHEON, South Korea—Celltrion…today announced that the U.S. Food and Drug Administration Arthritis Advisory Committee recommended approval of all indications for CT-P13, a proposed biosimilar to [JNJ’s] Remicade, by a vote of 21-3. CT-P13 is the first biosimilar monoclonal antibody (mAb) medication to be considered by the FDA.

The Committee based its recommendation on the totality of evidence presented at the Arthritis Advisory Committee meeting, comparing CT-P13 to the U.S. reference product, Remicade, in which the Committee concluded that the data submitted by Celltrion demonstrates CT-P13 is highly similar to U.S.-licensed Remicade, notwithstanding minor differences in clinically inactive components.

Further, the Committee noted that there were no clinically meaningful differences between CT-P13 and U.S.-licensed Remicade in terms of the safety, purity, and potency of the product in the studied indications of rheumatoid arthritis and ankylosing spondylitis. The Committee acknowledged the extensive data provided by Celltrion to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use.

Translation of the bolded sentence above: “We hope the FDA will listen to the advisory panel and approve CT-P13 for all five approved indications of branded Remicade (Crohn's disease, ulcerative colitis, RA, ankylosing spondylitis, psoriatic arthritis, and psoriasis), even through we conducted clinical trials in only two of those indications (RA and ankylosing spondylitis).”

PFE has the US commercial rights to CT-P13 by virtue of a 2009 collaboration between Celltrion and Hospira (#msg-84519981).

Remicade had annualized US sales of $4.8B in 4Q15.