Hospira says that it won European approval for its follow-on therapy to Amgen's blockbuster Neupogen. In winning the OK, Hospira provided late-stage data demonstrating that its therapy, Nivestim (filgrastim), had a comparable efficacy and safety profile to Neupogen.
Europe has sprinted ahead of the U.S. in its approval of biosimilars, follow-on therapies to the biologics like Neupogen that have dominated the market for years. This is the fifth European approval for a biosimilar to Neupogen.
With the FDA laying out a regulatory pathway for biosimilars in the U.S., Amgen's white blood cell booster is at the top of the hit list among a crowd of developers angling for approvals in the next two to three years. Unlike small molecule generics, though, anyone looking to gain a U.S. approval for a biosimilar will have to present a complete package of data on efficacy and comparative safety results--no easy task. But Hospira is promising to be a key player.
Nivestim is Hospira's second biosimilar. The company's erythropoietin biosimilar, Retacrit, is currently available in 17 European countries, and Hospira says it is the first US-headquartered company to market biosimilar drugs in Europe. The company's biosimilar pipeline also includes pegfilgrastim, a longer-acting version of filgrastim.
- check out the Hospira release
- here's the story from Reuters