FDA approved Pfizer biosimilar Epogen/Procrits

May 16, 2018  Source: Ddu 151

The FDA granted approval to Pfizer for Retacrit (epoetin alfa-epbx), which is used for the treatment of anemia,  biosimilar of Amgen, a drug which generated sales closely $ 1.8 billion in the U.S market last year for Amgen and Johnson & Johnson partners.  Retacrit also received the go-ahead to be used in RBC transfusions by U.S health regulators.

After the patent litigation issues with Amgen, Pfizer stated that it is moving ahead with launch plans for 2018 and also stated that Retacrit will be available in the U.S market at much-discounted rates to the current WAC of Epongen and Procrit. 

U.S regulators demanded Pfizer to submit more data for its application after the biosimilar company came up with the consideration. A year ago FDA liked the results and additional effort by Pfizer and given a go ahead. However, the FDA again pulled over the drug with a second CRL as the product was being manufactured at Pfizer’s Hospira plant in Kansas,  that received an FDA warning letter a few months ago.

The warning letter upbraids Pfizer for repeated failings throughout the manufacturing network of Hospira, which Pfizer had acquired for $15 billion in 2015. The drugmaker promised to solve the issues earlier this year and resolved FDA concerns about the facility.

After losing the key patents, Amgen and J&J continued to reap the benefits of a having an exclusive three years.

By editor