Replies to post #126244 on Biotech Values

[DewDiligence]

HSP’s Epogen project has modest commercial upside at best, IMO. The US market for Epogen biosimilars will probably end up looking like the one in Europe, where there are many branded products each generating a tiny market share.

I don’t think HSP will be a player at all in substitutable biogenerics.

[DewDiligence]

HSP starts US phase-3 trial for Epogen FoB:

http://finance.yahoo.com/news/Hospira-Announces-Start-U-S-prnews-2421610804.html?x=0

The program will enroll approximately 1,000 patients on hemodialysis who have already been treated with Epogen, and will take place at more than 200 different hemodialysis centers across the United States . Results are expected in 2013.

The application will presumably be submitted under the traditional BLA pathway rather than the new 351(k) pathway, and hence it has no chance to be approved as an interchangeable FoB.

This product is already on the market in Europe under the brand name, Retacrit.