Replies to post #204556 on Biotech Values

[DewDiligence]

Re: AMGN's Humira FoB

...interested to see what AMGN says about price/discount.

More interesting is whether/when AMGN decides to launch and take a chance against ABBV's battery of US patents on Humira's formulation, manufacturing process, and method of use (#msg-118781959).

[DewDiligence]

CHMP approves AMGN’s Humira FoB under two brand names—Amgevita (with a “g”) and Solymbic:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/01/news_detail_002682.jsp&mid=WC0b01ac058004d5c1

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500220219
http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500220220

Amgevita and Solymbic are the same drug, but Solymbic lacks approval for pediatric indications. I don’t know the reason for using dual EU brand names for AMGN’s Humira FoB; if anyone reading this does know, please post.

Note: AMGN’s Humira FoB for the US market is Amjevita (with a “j”): #msg-125359509, #msg-126114458.

[DewDiligence]

B-I reports phase-3 data for Humira FoB:

https://www.businesswire.com/news/home/20170614005617/en

As with other Humira FoBs, patent litigation will determine when these products can enter the US market. ABBV’s suit against AMGN (the first company to get FDA approval for a Humira FoB) involves 61 patents and has a trial date of Nov 2019.