Pfizer scores approval for first Epogen/Procrit biosimilar in the US
pharmafile | May 16, 2018 | News story | Research and Development, Sales and Marketing | Epogen, Pfizer, Procrit, Retacrit, biosimilar, pharma FDA
Pfizer’s Retacrit (epoetin alfa-epbx), a biosimilar version of Amgen’s Epogen and Janssen’s Procrit, has been approved for use in the US by the FDA, making it the first and only biosimilar erythropoiesis-stimulating agent (ESA) available in the country.
The drug has been approved in all indications of its reference product, namely the treatment of anaemia as a result of chronic kidney disease, chemotherapy, or the use of Zidovudine in patients with HIV. It can also be used to reduce complications stemming from blood loss when administered before or after surgery.
The US firm said that the FDA’s decision had been based on data demonstrating “a high degree of similarity between Retacrit and its US reference product”. As part of a deal signed by the two companies, Vifor Pharma will handle commercialisation duties for the drug in certain channels.
“With the approval of Retacrit, healthcare providers now have an additional option to choose from when prescribing an ESA,” said Dr George M Rodgers, Professor of Medicine, Division of Hematology and Hematologic Malignancies, Department of Internal Medicine, University of Utah School of Medicine. “By providing potentially more affordable therapeutic options, biosimilar medicines can allow for the reallocation of resources to other areas of cancer care. This is positive news for the oncology community.”
Dr Leah Christl, Director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research, added: “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. Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”
Matt Fellows
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