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Pfizer Gets FDA Nod for Amgen, J&J's Anemia Drug Biosimilar
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Pfizer Inc. (PFE - Free Report) announced that the FDA has granted approval to Retacrit, a biosimilar version of two blockbuster drugs – Amgen Inc.’s (AMGN - Free Report) Epogen and Johnson & Johnson’s (JNJ - Free Report) 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 - Free Report) 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.
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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Pfizer Gets FDA Nod for Amgen, J&J's Anemia Drug Biosimilar
Pfizer Inc. (PFE - Free Report) announced that the FDA has granted approval to Retacrit, a biosimilar version of two blockbuster drugs – Amgen Inc.’s (AMGN - Free Report) Epogen and Johnson & Johnson’s (JNJ - Free Report) 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 - Free Report) 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.
Pfizer Inc. Price
Pfizer Inc. Price | Pfizer Inc. Quote
Zacks Rank
Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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