No drugmaker stands to lose more to biotech copycat drugs than Amgen. Analysts think its blockbuster blood-cell boosters Epogen and Neupogen will be among the first drugs copied in the U.S., once lawmakers create a framework for their approval.
Epogen, which treats anemia, has been on the market for twenty years now, so its patents are soon to expire. Merck has said that its first biogeneric will be an Epogen copy. Neupogen already has competition in Europe, namely Novartis' generic version. Provided those two copycat meds negotiate the new regulatory pathway, Amgen could face competition--and declining revenues--in its home country tout suite.
And it's not just Epogen. Pharma research experts Decision Resources predict low-cost copies of the white-blood-cell booster Neupogen and of an Amgen arthritis med will hit the U.S. market by 2014. And together those three drugs accounted for half the company's 2008 sales, Forbes points out. "No other company has that same sort of exposure right now," says Decision Resources' Michael Malecki.
Amgen opposes automatic substitution of generic biotech meds for branded versions, saying it's impossible to make exact copies. The bills floating around Congress contain various rules by which "biosimilars" can be substituted for branded versions, so it's unclear just how easily the copycat makers will be able to convert Epogen patients to their versions. Plus, Epogen's biogeneric competitors in Europe haven't been super-successful in penetrating the market. So Amgen needn't put up the seige defenses--yet.