With health reform now officially law, Hospira has jumped in to challenge Amgen’s product portfolio.
Hospira said it will begin trials for a “biosimilar,” or a biogeneric, version of Amgen’s Epogen in patients with renal dysfunction who have anemia. Hospira’s version is called Retacrit in Europe, where patients can already get biosimilar drugs that are 20 to 30 percent cheaper than brand names.
The law is important as it clears a path for the FDA to approve biosimilar versions of brand-name biotech drugs. One catch? The FDA has not established guidance to drugmakers on how the approval process will work, given the law was enacted just four months ago. But the agency is allowing Hospira to begin clinical trials.
“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 as patents expire over the next several years.”
In the interview above from just a few months back, CEO Chris Begly discusses the advantages of biosimilars and how Hospira will approach the market.
