On November 13, Pfizer began marketing its biosimilar version of epoetin alfa. Pfizer launches Retacrit® at a 33.5% discount to Amgen’s reference product Epogen®.
Retacrit was originally developed by Hospira, which Pfizer acquired in 2015. Retacrit was one of the first biosimilars approved in the EU. It had a long journey to reaching the market in the US, however, including rejections by the FDA for manufacturing plant problems. It was finally approved by the FDA on May 15, 2018. The Retacrit launch comes 180 days after the approval.
The wholesale acquisition cost (WAC) of this biosimilar will be $11.03 per 1,000 units/mL, which represents an even steeper discount (57%) to Epogen’s sister product, Procrit® by Johnson & Johnson.
For Pfizer, this represents their third biosimilar being marketed today (along with Inflectra® and Nevistym®).
It has taken a long time, but Pfizer finally earned approval from the U.S. Food and Drug Administration (FDA) on the first biosimilar version of Epogen®. The drug, Retacrit® (epoetin alfa-epbx), had originally been submitted for approval in December 2014. Its much stalled road to approval is finally at an end.
After an initial rejection, the FDA’s Advisory Committee voted overwhelmingly (14–1) in May 2017 to give the product a green light. However, the FDA changed the traffic light to red, issued a second complete response letter in June 2017, citing issues with its manufacturing plant in McPherson, Kansas (a plant Pfizer inherited with its acquisition of Hospira).
Retacrit is approved for the treatment of anemia caused by chemotherapy or chronic kidney disease, for use in patients taking zidovudine for the treatment of HIV infection, and to reduce the need for red-cell blood transfusions before, during, or after surgery.
This is the 10th biosimilar approved by the FDA, and Pfizer is expected to shortly launch only the fourth biosimilar agent. Epogen’s patent has long expired, and it was one of the first biosimilars approved in Europe (in 2007). Retacrit has been marketed in the EU for over 10 years. It is one of four biosimilar epoetin products available overseas.
In other biosimilar news… Mylan’s earnings call on May 9 produced little clarity on the fate of its upcoming FDA decision on its pegfilgrastim biosimilar. Although CEO Heather Bresch believes that its product will represent one of its most important launches of the year, she could not shed any light on partner Biocon’s response to the FDA’s critical review of its manufacturing facility. The PDUFA date is June 4; a positive decision means that Mylan/Biocon will have beaten the competition to the market for this important biosimilar product.
Following a 14-1 vote by its Oncology Drug Advisory Committee last month to recommend approval for Pfizer’s biosimilar version of Epogen®, the Food and Drug Administration (FDA) on June 22 sent the drug maker a complete response letter outlining its decision to reject the product.
It is unusual for the FDA to decide against a clear majority recommendation by its Advisory Committee, but the agency pointed to potential manufacturing issues at one of Pfizer’s facilities. Pfizer stated, “This [complete response letter] relates to matters noted in a Warning Letter issued on February 14, 2017 following a routine [FDA] inspection of the company’s facility in McPherson, Kansas in 2016. This facility was listed as the potential manufacturing site in the BLA for the proposed epoetin alfa biosimilar. The issues noted in the Warning Letter do not relate specifically to the manufacture of epoetin alfa.” Although Pfizer responded to that notification by submitting a corrective and preventative action plan the following month, apparently, the FDA is not yet confident in the drug maker’s plan. According to Pfizer’s statement, the agency did not request that additional clinical data be submitted.
The FDA had cited this particular plant for several issues regarding the presence of foreign matter in medications being produced there. In its Warning Letter, the agency suggested there was “a significant loss of control in your manufacturing process” that represents a “severe risk of harm to patients.” The plant was one that Pfizer acquired in its purchase of Hospira in 2015.
This is Pfizer’s second rejection for Retacrit™, a product that was developed and brought to market in Europe by Hospira. Pfizer had resubmitted the 351(k) application in 2016.
The manufacturer stated that it is seeking to clear up any remaining issues at the plant cited by FDA. However, it is not clear whether Pfizer will have to resubmit its application entirely, as the rejection does not seem to be related to safety or efficacy issues involving the agent.