Pfizer Biosimilar, Retacrit Gets Approved In The U.S.

rPfizer has announced the approval of its biosimilar by the U.S. regulator, Food and Drug Administration (FDA). The drug by the name Retacrit, is a biosimilar version of two main drugs, Johnson & Johnson’s Procrit and Amgen’s Epogen.

Retacrit, which is already established in Europe, is registered for the treatment of anemia. Patients who suffer from the condition will now access the drug. Anemia is known to be caused by Zidovudine for those infected with HIV, chronic kidney disease or chemotherapy. Those undergoing surgery also stand to benefit, because Retacrit is also used to reduce allogeneic red blood cell (RBC).

Win-Win situation

Getting the approval was not an easy task, Pfizer Inc. had to produce a very detailed report highlighting the high rate of semblance between Retacrit on one side and Procrit and Epogen on the other. Nonetheless, the drug will come as a relief to patients as it is cheaper than Procrit and Epogen, sentiments echoed by Pfizer, that it will market the drug at a significant profit. This fits well with Trump’s administration as well as the administration have been rallying against expensively-priced drugs.

If current statistics are anything to go by then Pfizer have reason to be optimistic about projected sales. In 2017, Procrit generated revenues of $972 million and Epogen achieved $1.1 billion. Retacrit entering the market as a cheaper but still, a safe alternative promises good revenues as well. However, analysts believe that the drug’s reduced price will not necessarily hurt the other two, Epogen and Procrit. This is despite the fact that the latter faces competition in Europe from biosimilar drugs like NVS Binocrit which is manufactured by Novartis.

Side Effects

Recratic, which is the first eboetin alfa biosimilar to be approved in the U.S. has its share of shortcomings. Just like any other drug, it has its fair share of side-effects. For those treated for red blood cell related conditions, it can cause heart problems like heart failures or heart attacks. The danger of getting blood clots is also listed for those taking Recratic. For the cancer patients, accelerated tumor growth is a concern while taking the drug.

Recratic is not the only approved Pfizer’s biosimilar. There is Inflectra, that was approved prior. This is a biosimilar version of Remicade which is owned by J&J. More biosimilar drugs are also in various development stages being worked on by Pfizer.

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