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Pfizer Gets FDA Nod for Amgen, J&J's Anemia Drug Biosimilar

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Pfizer Inc. PFE announced that the FDA has granted approval to Retacrit, a biosimilar version of two blockbuster drugs – Amgen Inc.’s AMGN Epogen and Johnson & Johnson’s JNJ Procrit.  Pfizer already markets the biosimilar in Europe

Retracrit is indicated for the treatment of anemia due to chronic kidney disease, anemia due to Zidovudine in HIV-infected patients and anemia due to the effects of concomitant myelosuppressive chemotherapy (anemia post chemotherapy). The drug is also approved for the reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Retacrit becomes the first biosimilar erythropoiesis-stimulating agent approved in the United States.

Procrit generated sales of $972 million while Epogen’s sales were $1.1 billion in 2017. The sales numbers suggest bright prospects for Retacrit as it will be a lower cost alternative treatment option for patients using Procrit/Epogen. However, Procrit already faces biosimilar competition from drugs like Novartis’ NVS Binocrit in Europe.

Pfizer’s shares have declined 1.5% so far this year, comparing favorably with a fall of 3% recorded by the industry.

The approval was supported by a comprehensive data package that demonstrated a high level of similarity of Retacrit with Epogen and Procrit. In May last year, the FDA’sadvisory committee had recommended approval of Retacrit

Pfizer has entered into collaboration with Switzerland-based Vifor Pharma for the commercialization of Retacrit in certain channels.

Retacrit is the third approved biosimilar in Pfizer’s commercial portfolio which includes Inflectra, a biosimilar version of J&J’s Remicade. The company is also developing 11 different biosimilar candidates in several mid-to-late stage studies.

As the Trump administration continues to rally against exorbitantly high drug prices, the FDA has been actively approving generics/biosimilar of expensive branded drugs in a bid to bring down prices through competition. We saw several such approvals in 2017 and expect the trend to continue this year.

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