Pfizer, on third try, wins FDA nod for biosimilar of blockbuster Epogen/Procrit

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Pfizer says its newly approved Retacrit, a biosimilar of blockbuster anemia drug Epogen/Procrit, will be priced at a significant discount to the original shared by Amgen and Johnson & Johnson. (Pfizer)

After a couple of misfires, Pfizer has finally won FDA approval for its biosimilar of anemia drug Epogen/Procrit, a drug whose U.S. sales generated about $1.8 billion last year for partners Amgen and Johnson & Johnson.

The FDA approved Retacrit (epoetin alfa-epbx) on Tuesday for the treatment of anemia caused by chronic kidney disease, chemotherapy or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

“While launch timing will ultimately depend on a number of factors, we are moving ahead with the preparation of our launch plans for 2018,” Pfizer said in a statement that seemed to allude to patent litigation it has been fighting with Amgen.

As far as pricing, Pfizer said only that “Retacrit is expected to be available in the U.S. at a significant discount” to the current wholesale acquisition cost (WAC) of Epogen and Procrit.”

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Pfizer’s biosimilar candidate initially came up for consideration in 2015, but the FDA instead issued a complete response letter and insisted that Pfizer produce more data for its application. The FDA liked the results of that additional effort and a year ago an FDA advisory panel voted 14-1 in favor of recommending approval.

A month later, however, the FDA again sidelined the drug with a second CRL. This time it was because the biosimilar was being manufactured at Pfizer’s Hospira plant in McPhearson, Kansas, that had been issued an FDA warning letter several months earlier.

The problems at the plant were laid out in a scathing warning letter that chastised Pfizer for repeated failings throughout the manufacturing network of Hospira, which Pfizer had acquired in 2015 in a $15 billion deal. The drugmaker promised to get on top of the problems and earlier this year, it indicated it had resolved FDA concerns about the facility.

RELATED: Pfizer plant slapped with FDA warning letter for not learning from earlier mistakes

While all of this played out, Amgen and J&J continued to reap the benefits of a having an exclusive three years after losing key patents. Amgen even took a price hike this year on the drug.

J&J, at least, saw the writing on the wall. The company in its 2018 financial guidance took into account the company’s assumption that competition would materialize this year.