Drug: Neupogen
Generic: Filgrastim
Company: Amgen ($AMGN), Kirin, Roche ($RHHBY), Royalty Pharma
Patent expiration date: Roche, Royalty Pharma, March 12, 2013 | Amgen-Kirin Dec. 12, 2013
Estimated Global Sales 2012: $1.29 billion

The scoop: The white blood cell booster for cancer patients has been on the market since 1991, and it's been a significant producer for Amgen all of that time. Marketing rights for the product are shared by a number of companies for different areas throughout the world. Most of the sales are Amgen's, however; Kirin recognized only $188 million from it last year. Competition is on the way, sort of. In August, Teva Pharmaceutical Industries ($TEVA) received U.S. approval for Tevagrastim, its biosimilar version of Neupogen. Unlike standard generics, biosimilars can't simply be substituted for Neupogen. Teva had to do clinical trials, and doctors will have to prescribe its version by name. Teva already sells its Neupogen version in Europe, but so far has picked up only about 5% of the market there. In a legal settlement with Amgen, Teva can launch its version in the U.S. in November 2013, just ahead of the patent expiration. Others are working on biosimilars as well. Hospira ($HSP), for instance, already has approval in Europe for its follow-on therapy, Nivestim, so it promises to be a key player fairly quickly. Still, Amgen, the world's largest biotech company, just turned in third quarter results showing sales and earnings gains, and beating Wall Street estimates, putting it in a position most other drugmakers can only hope to see in the future.

For more:
Teva's Neupogen-knockoff approval highlights slow progress of biosims
Hospira gains EMA OK for Neupogen biosimilar


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