Pfizer wins approval of Nivestym, biosimilar of Amgen's Neupogen

Pfizer building
Pfizer has won approval of another biosimilar. (Tracy Staton)

Pfizer has added another offering to its biosimilar portfolio, having won FDA approval of its version of Amgen’s oncology treatment Neupogen. The approval comes as the Pharma giant is giving added emphasis to biosimilars by moving them under its branded drug division.

The FDA on Friday approved Nivestym for all eligible indications of Neupogen, a white blood cell booster that generated $549 million last year for Amgen. It said the approval was based on a review of a comprehensive data package that showed the drug had a high degree of similarity to the reference product.

“We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients,” Berk Gurdogan, U.S. institutions president for Pfizer Essential Health, said in a the release


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RELATED: Why another Pfizer reorganization? Bigger bets on biosimilars, maybe—or finally a generics selloff

The drugmaker did not say how it will price the drug, only that it would sell it at a significant discount to the current wholesale acquisition cost (WAC) of Neupogen. WAC is the price before discounts to payers, providers, distributors and other purchasing organizations.

Pfizer’s offering comes to the market after biosimilars of Neupogen from Novartis and Teva and as sales of the Amgen's drug have dropped precipitously, down 28% in 2017.

Biosimilars have been a growth driver for Pfizer. In the first quarter, Pfizer’s biosimilars revenues grew 53% to $173 million. Besides its approved Remicade and Epogen/Procrit copycats, Pfizer is developing biosimilars to some of the industry’s other best-sellers, including Humira, Avastin, Rituxan and Herceptin. But Pfizer thinks they can do more. 

RELATED: FDA chief Gottlieb blames drugmakers for ‘anemic’ biosimilar market

In a reorganization that will take effect in January 2019, Pfizer will move its biosimilars program out of its established drug unit where they have been and into its innovative drug-development group. Analysts believe the move makes sense.  

The biological copycats require more R&D investment than small-molecule generics, and they are being launched and marketed like novel drugs, an approach that its established drug unit has not been able to pull off with Pfizer’s version of Johnson & Johnson’s Remicade.

In that case J&J has protected its Remicade sales by offering deep discounts to payers who lock in exclusive contracts for the drug. The method has worked for J&J but drawn a lawsuit from Pfizer and indirect criticism from the head of the the FDA. Director Scott Gottlieb, M.D., in a speech last week said drugmakers have thwarted “competition by dangling big rebates to lock up payers in multiyear contracts right on the eve of biosimilar entry.”

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