Amgen is bringing U.S. contracting strategies to Europe as part of its efforts to stave off competition from biosimilars, Exec VP-Commercial Operations George Morrow said during the firm's recent annual business review.

" Neulasta conversion really had an inflection point up this past year. We took some novel contracting strategies over to Europe and that's really helped," Morrow said.

Such contracting strategies are "really important when we talk about follow-on biologics and how we are going to defend ourselves," he added.

Morrow did not specify what contracting strategies the firm would use. However, the approach may involve rebate bundling.

In order to drive Aranesp use in the U.S., Amgen has tied Neulasta and Neupogen rebates to Aranesp utilization volume relative to Johnson & Johnson's erythropoiesis-stimulating agent Procrit .J&J has filed suit, alleging the tactic is anti-competitive (¹ Also see "Amgen Expects Stable Aranesp Pricing Despite J&J Lawsuit Over Rebates" - Pink Sheet, 24 October, 2005., p. 22).

Driving European utilization towards Neulasta and Aranesp is a key component of Amgen's strategy for competing with biosimilars.

In addition, Amgen wants to avoid reference pricing of its second-generation, patent-protected products with first-generation precursors, Morrow said, noting such policies are determined on a country-by-country basis.

"Remember, Aranesp and Neulasta are not facing follow-on biologics, the first-generation products are," he said. "We don't want Aranesp and Neulasta to be lumped in with those products in reference pricing, so we are going to work real hard on that."

Conversion of Neupogen use to Neulasta in Europe has reached 59%, Morrow reported. Aranesp conversion jumped from approximately 30% to 45% during the third quarter of 2005, he said.

Europe has moved ahead of the U.S. in establishing a pathway for follow-on biologics; the European Medicines Agency has released a general guidance document on the approval requirements for biosimilars, as well as specific guidances relating to erythropoietin, insulin, human growth hormone and granulocyte-colony stimulating factor (Neupogen, Neulasta) follow-ons (² [A#00670320022], p. 30).

Morrow said Amgen did "a nice job" working with European regulators on the development of the biosimilar approval pathway. "The overarching guidelines will require...lots of studies before you get a biosimilar on the market [and] lots of studies afterwards to make sure that these molecules, which are not identical to the innovator molecules, are not doing any harm."

Amgen expects competition from biosimilar EPO products in Europe in late 2006 or early 2007. The firm's strategy for competing with generic EPO entries is to establish Aranesp (darbepoetin alfa) as the "standard of care" in the market.

The firm plans to "build a label that almost makes the follow-on biologics look primitive," Morrow said. The exec pointed to ongoing cardiovascular outcomes trials in chronic kidney disease patients (TREAT) and heart failure patients as the type of data that could differentiate Aranesp in labeling (³ Also see "Amgen To Study Aranesp Anemia Indication In Heart Failure Patients" - Pink Sheet, 25 July, 2005., p. 14).

Morrow also pointed to the SureClick administration device for Aranesp as another tool for differentiating the product from biosimilars.

Amgen wants to ensure that biosimilar products are marketed under unique trade names rather than the generic names. Unique names for biosimilars would "help from a postmarketing surveillance standpoint, tracking these compounds," Morrow noted.

The firm is also working to ensure that there are not automatic substitution policies for biosimilars, Morrow said. "This is a decision the doctor ought to make and ought to weigh the potential economic questions - which we don't think are going to be tremendous - with clinical data and safety concerns," he added.

CEO Kevin Sharer emphasized that the entry of biosimilars in Europe will help Amgen prepare for follow-on protein competition in the U.S.

"Fortunately for our business, we will be able to get experience in a relatively small market compared to...the whole company's operation," Sharer said. "That will allow us to learn for the day some years [from now] - five, eight or nine, whatever it is - hence when we face that in America."

Amgen Looks To U.S. Contracting Strategies To Head Off European Biosimilars

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