FDA approves Pfizer’s epoetin biosimilar Retacrit

The FDA has approved Pfizer’s biosimilar drug, Retacrit, a cut price competitor Amgen and Johnson & Johnson’s bone marrow stimulating drug epoetin alfa.

Retacrit (epoetin alfa-epbx), is a biosimilar to Epogen and Procrit (epoetin alfa). It is the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the US. Epoetin alfa is marketed by Amgen as Epogen and by Johnson & Johnson as Procrit.

ESAs stimulate bone marrow to make red blood cells. They are also used to treat anaemia caused by end-stage kidney disease, chemotherapy, major surgery, or certain HIV/AIDS treatments.

Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions (RBC) will be needed due to blood loss. It is administered via an injection.

Pfizer submitted a comprehensive data package to demonstrate a high degree of similarity between Retacrit and the reference drug, Epogen and Procrit. This was the company’s third attempt to win approval in the US.

In Europe, biosimilars of epoetin have been on the market since 2007. Medice Arzneimittel Pütter’s Abseamed, Sandoz’s Binocrit and Hexal’s Epoetin alfa Hexal have been available in Europe for around 11 years.

The FDA reviewed evidence from Pfizer that included extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity findings and other clinical safety and effectiveness data, which demonstrated that Retacrit is biosimilar to Epogen and Procrit.

Berk Gurdogan, US institutions president, Pfizer Essential Health, said, “As the first approved epoetin alfa biosimilar in the US, Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anaemia and the reduction of allogeneic red blood cell (RBC) transfusions in certain patients.

“We are proud of the progress of our biosimilars programme to date, which will help address the evolving needs of patients and the broader healthcare community.”

Biosimilars are biological products that are approved based on data showing that they are highly similar to a biological product already approved by the FDA (known as the reference product). They must have no clinically meaningful differences in terms of safety, purity and potency to the reference product.

Leah Christl, director of the therapeutic biologics and biosimilars staff in the FDA’s Centre for Drug Evaluation and Research, said, “It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products.”



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