In the wake of health reform’s passage, Hospira Inc. will begin testing an experimental cheaper version of a popular anemia treatment in the first phase of a U.S. clinical trial.
A path for the Food and Drug Administration to approval “biosimilar” or biogeneric drugs was a part of health reform legislation passed by Congress and signed into law four months ago by President Barack Obama. Biotech brands are available only outside the U.S. but the law will enable biosimilars here in the coming years.
Lake Forest-based Hospira said it will begin so called “Phase I” trials of its biosimilar of the anemia drug Epogen in patients with kidney dysfunction who have anemia. Hospira’s version, known as Retacrit, is in Europe where patients are benefiting from biosimilar drugs that are 20 to 30 percent cheaper.
Though FDA has not established guidance to drugmakers on how the approval process will work given the law was enacted just months ago, the agency is allowing Hospira to begin clinical trials. Hospira said it will test Retacrit in a comparison with brand-name Epogen, sold by biotech giant Amgen Inc. of California.
Biotech brands such as Epogen are unavailable in the U.S. in biogeneric form because they were not part of the 1984 Hatch-Waxman law that allowed for cheaper generics. That law largely covers products derived from chemicals, such as the cholesterol drug Zocor and the antidepressant Zoloft.
Hospira’s trial of Epogen, or “epo” as it is commonly known, will take place at 20 hemodyalisis centers in the U.S. Pending success of the first phase, the trial will be expanded next year, Hospira said. The company would not speculate on possible approval of the biosimilar version of Epogen.
The company did, however, say it will be the first of many biosimilar versions of brand name biotech drugs.
“This trial marks a key milestone for Hospira’s biosimilars program,” said Dr. Sumant Ramachandra, Hospira’s chief scientific officer. “We hope to leverage our leadership in generics and our biosimilars experience in Europe to make affordable, safe and effective biosimilars available to U.S. patients.”
In the health reform debate, supporters of biosimilars say the eventual introduction of the cheaper biotech drugs will bring savings of $10 billion a year in the U.S.
