The FDA has caused more than a little grumbling in the payer community with its oh-so-slow approach to hammering out new regulations on the development of biosimilars in the U.S. But there are a number of developers out there who aren't waiting for every regulatory "i" to be dotted and every "t" crossed before they jump into the clinic.
Exhibit A: Hospira's ($HSP) recently announced plans to jump into a late-stage U.S. study for its generic version of Amgen's Epogen, a goldmine anemia treatment that has produced blockbuster revenue for years. The New York Times has tapped the program as the most advanced biosimilar development project in the U.S. And it helps underscore the potential for a next-gen wave of less-expensive--though far from cheap--follow-on biologics.
In a Phase I study involving 100 patients, Hospira's investigators dosed renal dysfunction patients suffering from anemia with both Amgen's treatment as well as its own version of EPO, switching them after a week of therapy. Earlier this month Hospira reported that their drug performed on par with the Amgen blockbuster. And Hospira wasted no time in shifting gears to a Phase III study, which is slated to begin before the end of this year.
"The successful completion of our Phase I EPO trial is an important step for Hospira's U.S. biosimilars program," Hospira's Chief Scientific Officer Sumant Ramachandra said in a statement earlier this month. Hospira already sells a biosimilar version of the anemia drug in Europe, where regulators have been quicker to lay out a pathway to an approval. And the company is clearly chomping at the bit to get clearance in the U.S.
"Biosimilars are not miracle drugs," Hospira CEO Michael Ball recently told analysts, according to The New York Times piece. "They are real. We are really selling them in Europe, we're really selling them in Australia and we will be selling them here in the United States."
Earlier this month Hospira execs told analysts they were looking forward to the day when the biosimilars market would be worth $116 billion. And they're driving to grab a piece of that for themselves with initial U.S. launches planned for 2013 to 2015. Hospira is also building a 1.1 million-square-feet manufacturing facility in India--which the company emphasizes is not related to the biosimilars initiative--to keep its generic drug costs low.
- see the Hospira release on the program
- here's the article from The New York Times