In what's described as an early-stage clinical trial, Hospira (NYSE: HSP) has unveiled plans to take its biosimilar of Amgen's anemia drug Epogen directly into a head-to-head study designed to swiftly pivot into a large, late-stage study.
The Chicago-based company plans to recruit hemodialysis patients at 20 different centers across the U.S. But unlike a typical Phase I study, researchers will immediately study both safety and efficacy of the therapy, Retacrit, in comparison with the market-leading drug. If it's successful, the study will vault into a Phase III trial next year.
"This trial marks a key milestone for Hospira's biosimilars program," says Sumant Ramachandra, a senior vice president at Hospira. "Congressional approval of a regulatory pathway for biosimilar drugs in the U.S. set the stage for our development of a U.S. biosimilar EPO. 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 and their healthcare providers once patents expire over the next several years."
Retacrit is already available in Europe, where it now has a more than 50 percent share of the "total short-acting EPO biosimilar market." This study illustrates the new approach that developers will take on clinical trials for biosimilars. Jumping past much of the early- and mid-stage research required for new chemical entities, companies can move quickly into Phase III, which requires deep pockets.
- here's the press release
- here's the story from the Chicago Tribune