Neulasta

Neulasta (pegfilgrastim)
Company: Amgen
Condition: Infection reduction in cancer patients on chemotherapy
Global 2013 sales: $4.4 billion
U.S. patent expiration date: October 2015 

Biosimilars are a bittersweet affair for Amgen ($AMGN). The biotech has a biologic blockbuster that's sliding off patent next year, but it's also positioning itself to be a major biosimilar provider. No biosimilar applications have yet been approved by the FDA, although the agency released draft guidance on the clinical and regulatory pathway for biosimilars in May. The agency received comments on it into August.

Neulasta is a pegylated, longer-acting version of Amgen's Neupogen. Teva ($TEVA) already has EU-approved biosimilar versions of Neupogen and Neulasta. Other companies have also committed to making generic versions of Neupogen or Neulasta or both, such as Sandoz and Coherus. But Amgen itself hasn't said it will go after the biosimilar market for these products. Amgen does have its own full biosimilar pipeline from which it expects to start launching products in 2017.

In 2013, Neulasta had $4.4 billion in global revenues, making it one of Amgen's top revenue-generating products, just a bit behind Enbrel. In combination, Neulasta and Neupogen produced $5.8 billion in sales last year.

Amgen, along with AbbVie ($ABBV) and Roche ($RHHBY), are seen by Wall Street as most vulnerable to the nascent onslaught of biosimilars. But investors still seem to like Amgen's newfound swagger, with its $10.4 billion purchase of Onyx Pharmaceuticals last year and its ambitious biosimilars program. The company is now perceived as more ambitious than it has been for years. Investors are still cheering, sending Amgen up 21% in 2014 through the end of September.

For more:
To substitute or not to substitute? Biotechs and biosim makers compromise on legislation
AbbVie, Amgen and Roche most vulnerable to biosim rivals, Moody's says
Amgen, Onyx huddle on $9.5B deal as other bidders fall away

-- Stacy Lawrence (email | Twitter)

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