First US Epogen Biosimilar Approved as Pfizer Fixes GMP Issues in Kansas

The FDA upgraded Pfizer’s troubled McPherson, Kansas facility in January paving the way for the approval of Retacrit – a biosimilar version of Amgen’s Epogen (epoetin alfa).

The US Food and Drug Administration (FDA) approved Retacrit as the first biosimilar version of Amgen’s anemia drug Epogen yesterday.

“The FDA’s decision to approve Retacrit for all indications of the reference product marks a critical and positive step forward in helping create a marketplace for biosimilars in the US, further advancing opportunities to expand patient access to high-quality, lower-cost alternative treatment options,” Pfizer spokesperson Thomas Biegi told BioProcess Insider.

He added Pfizer is moving ahead with preparation to launch Retacrit – branded as Procrit by Janssen – later this year, though no date has been announced.

“Retacrit is expected to be available in the US at a significant discount to the current WAC [wholesale acquisition cost] of Epogen and Procrit, but we cannot comment on our specific pricing or commercialization strategies.”

The approval marks another first for Pfizer in bringing biosimilars to the US. In 2016, Pfizer’s Inflectra (infliximab) became the first monoclonal antibody biosimilar to be approved and launched in the region.

Kansas Remediations

Retacrit will be produced at Pfizer’s manufacturing facility in McPherson, Kansas.

Image: Getty/Rainer Lesniewski

Pfizer added the plant to its network through the US$17 billion (€14.3 billion) Hospira acquisition in 2015. However, the plant has been subject to various regulatory issues, resulting in an FDA warning letter in February 2017.

The FDA cited the GMP issues in a complete response letter (CRL) sent June 2017 rejecting a second Retacrit submission. But a regulatory upgrade of the plant in January helped drive this week’s FDA approval, Biegi said.

“In January 2018, the FDA upgraded the status of Pfizer’s McPherson, Kansas manufacturing facility to Voluntary Action Indicated (VAI) based on an October 2017 inspection.

“The change to VAI status will lift the compliance hold that the FDA placed on approval of pending applications and is an important step toward resolving the issues cited in the February 2017 FDA Warning Letter.”

Hospira first submitted Retacrit in January 2015 and received a CRL later that year after the FDA demanded more evidence to support approval.

Adverse Impact on Epogen Sales

Epogen clocked in US sales of $1.1 billion for Amgen in 2017, while Procrit brought in sales of $675 million for J&J subsidiary Janssen. Sales have been in a steady decline due to changing Medicare reimbursement rules and indirect competition.

And Amgen expects continued “material adverse impact” as biosimilars like Retacrit hit the market, a spokesperson told us.

However, “Amgen will continue to promote the robust clinical data of our erythropoiesis-stimulating agent (ESA) products including Epogen, with nearly 29 years of experience. In addition, we continue to promote Aranesp, to treat anemia due to chronic kidney disease and anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.”

The firm also has fixed contracts with dialysis centers and dialysis systems, including DaVita, which will ensure continued sales over the next few years.

“DaVita has committed to purchase Epogen and Aranesp in amounts necessary to meet a at least 90 percent of the company’s and its affiliates’ requirements for ESAs in the US in each year through 2022.”