Summary: Retacrit is a biosimilar version of epoetin (reference products, Epogen (epoetin alfa, Amgen, Inc.) and Procrit (epoetin alfa, Janssen) manufactured by Pfizer. This biosimilar was originally developed and sold in Europe by Hospira (which was acquired by Pfizer) under the nonproprietary name of epoetin zeta.
A biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in December 2014; was recommended for approval in May 2017 and rejected in June 2017 due to manufacturing issues; and then approved in May 2018. Pfizer launched Retacrit in November 2018, at a significant discount compared to the wholesaler acquisition cost of the reference products. Vifor Pharma will market the drug in the dialysis market while Pfizer will market the drug for all other indications.
About the Manufacturer
Pfizer entered the biosimilar market through two avenues: (1) its acquisition of Hospira and (2) its own internal pipeline development. Pfizer was established in 1849, and it is headquartered in New York City. It has a considerable portfolio of biosimilar products approved by the FDA and in various stages of filing. In addition to Retacrit, its approved biosimilars include Inflectra, the first biosimilar version of Remicade; Ixifi, another version of Remicade that will be sold overseas only; and Nivestym, a biosimilar filgrastim that was approved in 2018. Pfizer’s biosimilar pipeline consists of a biosimilar trastuzumab, bevacizumab, and rituximab, all being filed for approval with the FDA; biosimilar adalimumab in phase 3 trials; and biosimilar pegfilgrastim in phase 1 development.
News, Commentary, and Intelligence
Competitor Products and Manufacturer Analysis
Pfizer began selling Retacrit at a wholesale acquisition cost discount of 33.5% to Epogen and a 57% discount to Procrit. It is the first biosimilar version of epoetin sold in the US. In contrast, five biosimilars of epoetin were approved by the European Medicines Agency.
A search for other late-stage biosimilar candidates that may potentially to seek approval in the US yielded no results. For example, Sandoz, which markets Biocrit in the EU, does not list epoetin in its US pipeline. The total epoetin alfa market was about $1.8 billion in 2017. Darbepoetin alfa (Aranesp by Amgen) does compete for prescriptions with epoetin, and several biosimilar manufacturers (e.g., Apobiologix) is involved in early-stage research on this product. Amgen has been seeing decreasing sales of both originator biologic products in recent years.
Pfizer Launches Retacrit, First Biosimilar Version of Epogen and Procrit
(November 14,, 2018) Pfizer began marketing its biosimilar version of epoetin alfa. Pfizer launches Retacrit® at a 33.5% discount to Amgen’s reference product Epogen®.
Part B to Part D and Other Questions: How CMS’s Plans Could Affect Biosimilars
(August 10, 2018) Some of these tactics are a bit late to the party, as commercial insurers and health plans have been employing them for years. To the extent that an injectable treatment can be managed through the pharmacy benefit rather than the medical benefit, the drug can be easily subjected to prior authorization, step therapy, quantity limits, and other tools routinely used.
Pfizer Gets FDA’s Green Light on Its Filgrastim Biosimilar
(July 21, 2018) On July 20, the US Food and Drug Administration (FDA) approved the second biosimilar version of filgrastim. Pfizer’s filgrastim biosimilar is named Nivestym™(filgrastim-aafi).
Convincing Two Main Providers the Key to Pfizer’s Retacrit Success
(June 1, 2018) Not only does Retacrit® need to pass muster with payers like health plans and insurers, which we assume it will, but Retacrit will need to be accepted by the two 800-pound gorillas of the kidney dialysis field.
Pfizer Gets Green Light From the FDA on Epogen® Biosimilar
(May 15, 2018) 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.
More Clinical Study Evidence That Biosimilar Switching Carries a Low Risk
(March 6, 2018) A literature review published this past weekend in Drugs reaffirms what most parties interested in biosimilars suspect—that switching from a reference product to biosimilar is not a significant clinical concern. Biosimilar switching was not generally associated with poorer outcomes.
FDA Stuns With Rejection of Pfizer’s Retacrit
(June 26, 2017) 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.
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