FDA Response Delays Pfizer's Release of Epogen Biosimilar

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By John T. Aquino

Oct. 27 — Pfizer Inc. announced Oct. 27 that it received a response letter from the FDA that will delay the release of Retacrit, its proposed biosimilar of Amgen's anemia drugs Epogen and Procrit, until 2016.

Pfizer Chief Executive Officer Ian Read didn't describe the Food and Drug Administration letter in detail in his remarks during a third-quarter conference call. A response letter would suggest that the FDA indicated it wasn't in a position to approve the biologics license application (BLA) for the biosimilar at this time.

Surprise FDA Action

Mackay Jimeson, media relations director for Pfizer, told Bloomberg BNA in an Oct. 27 e-mail, “We are working closely with the agency to address the content of the letter and, at this time, we do not believe any further clinical trials are needed. We anticipate being in a position to file our response in the first half of 2016. Pfizer is confident that the additional evidence we provide will support approval and remains committed to bringing this important medicine to patients in the U.S. as quickly as possible, which will increase access to safe, effective and more affordable biologic medicines.”

The news came as something of a surprise because as recently as early October, analysts were anticipating that the FDA would approve Retacrit for market by mid-October, making it the second biosimilar approved under the Biologics Price Competition and Innovation Act. Sandoz's Zarxio, a biosimilar of Amgen's cancer treatment Neupogen that was approved by the FDA in March, was the first.

A biosimilar is a biologic product that is approved for market by the FDA based on a showing that it is highly similar to an already-approved biologic product, known as a reference product.

Already Approved in EU, U.K.

Hospira filed its BLA for Retacrit in January. Pfizer acquired Retacrit when it purchased Hospira in February.

Amgen's Epogen (epoetin alfa) and Procrit (epoetin alfa) are erythropoiesis-stimulating agents used to treat anemia in patients with chronic kidney disease.

Hospira received market authorization from the European Union for Retacrit as a biosimilar in 2007 and from the U.K. in 2014.

Warwick Smith, director-general of the British Generic Manufacturers Association, posted an article Oct. 27 on the Pharmafile news portal, before the Pfizer conference call, that described the U.K. approval of Retacrit titled, “More work remains if biosimilars are to fulfil their potential.”

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