Hospira to test generic anemia drug
Lake Forest-based Hospira said it will begin the first phase of trials for a "biosimilar," or a biogeneric, version of brand-name Epogen in patients with renal dysfunction who have anemia. Hospira's version is called Retacrit in Europe, where patients can get biosimilar drugs that are 20 to 30 percent cheaper than brand names. Hospira would not disclose a price for Retacrit.
The new health reform law clears a path for the U.S. Food and Drug Administration to approve biosimilar versions of brand-name biotech drugs. Biotech drugs in biosimilar forms are unavailable in the U.S. because they were not part of the 1984 landmark Hatch-Waxman law that allowed for cheaper generics. That law largely covers products derived from chemicals.
Because biotech drugs are derived from living cells and, therefore, are more complex to make, the new law is requiring lengthy clinical trials before they are approved in less expensive biosimilar form.
Source: Chicago Tribune
