Forbes magazine makes the case that gaining an approval for denosumab is a 'must-win' for Amgen, which is being pressured by competing biosimilar bills in Congress.
With big manufacturers like Merck already beavering away at new biosimilars that can do the work of an old anemia therapy like Epogen, which earns $2.5 billion a year, Amgen is the single most vulnerable biotech company in the industry when it comes to stripping away patent protection. And analysts say that the big biotech company has to gin a new franchise that can also bring in billions of dollars every year.
It's "almost make-or-break for the company," says Geoffrey Porges, biotechnology analyst at Sanford C. Bernstein.
For its part, though, Amgen isn't sweating it out publicly. Biosimilar competition in Europe hasn't appreciably cut into the franchise on the continent, execs say, and no one can make a copycat version of their anemia therapies.
"You can make red wine or Châteauneuf-du-Pape. They are both red and both have alcohol in them, but they are quite different," says Amgen Senior Vice President David Beier.
- read the article from Forbes