FDA Rejection of Pfizer’s Biosimilar Extends Epogen, Procrit Exclusivity

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By John T. Aquino

Manufacturing problems have derailed Pfizer’s biosimilar for Amgen’s and J&J’s anemia treatments from imminent release, Pfizer announced.

The Food and Drug Administration’s Oncologic Drugs Advisory Committee recommended approval of Pfizer subsidiary Hospira Inc.'s epoetin alfa biosimilar 14 to 1 on May 25, finding it highly similar to Amgen’s Epogen and Johnson & Johnson’s Procrit for all indications, including dialysis-induced and chemo-induced anemia.

But the FDA’s complete response letter to Pfizer’ biologic license application (BLA) referenced continued manufacturing concerns, according to Pfizer’s June 22 press statement. These concerns were previously expressed in the agency’s Feb. 14 warning letter after its inspection of Pfizer’s facility in McPherson, Kan. Pfizer’s BLA listed the McPherson plant as the biosimilar’s probable manufacturing site.

Bloomberg Intelligence said in a June 23 posting the FDA’s second rejection of Pfizer’s BLA pushes the FDA’s approval of the first Epogen/Procrit biosimilar to 2018, noting manufacturing defects can take a year or more to correct. This gives Amgen and J&J a surprise reprieve from biosimilar competition, BI stated. Amgen reported $1.3 billion in Epogen 2016 U.S. sales and J&J reported $767 million for Procrit 2016 U.S. sales.

The agency had previously rejected the same biosimilar in 2015, citing the need for more clinical data.

No More Clinical Data Needed

A biosimilar is a biologic product that is highly similar to a biologic drug previously approved by the FDA and has no clinically meaningful differences in terms of the safety, purity, and potency. Biosimilar prices are expected to be 15 percent to 30 percent lower than those of the original biologic.

The FDA’s inspection of the McPherson facility, which was conducted in May and June 2016, found “significant violations of current good manufacturing practice” rules. At the plant, inspectors observed practices that could have contaminated sterile products and said Hospira/Pfizer failed to respond appropriately after drugs were found to be contaminated with cardboard and other particles, according to the warning letter.

Inspectors also found conditions that show “significant loss of control in your manufacturing process” that represents a severe risk of harm to patients. Pfizer acquired the plant with its $17 billion takeover of Hospira in 2015.

In its press statement, Pfizer noted the issues raised in the warning letter don’t relate specifically to the manufacture of epoetin alfa. The company stated it submitted a McPherson facility corrective and preventative action plan to the FDA in March 2017 and provides regular updates to the agency on the status of its action plan. It added the FDA didn’t request additional clinical data to support an approval for the biosimilar.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

Pfizer's announcement of FDA's letter is at http://src.bna.com/qcs

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