Hospira post-marketing study of biosimilar epoetin meets primary endpoints

June 6, 2013 10:09 AM

Hospira, Inc., announced this week the results from a post-marketing study of the company’s European biosimilar epoetin, Retacrit.

This prospective, observational study met the primary endpoint, as defined by hemoglobin treatment response, in the management of chemotherapy-induced anemia in adult patients with solid tumors, lymphomas and myelomas, regardless of chemotherapy cycle. Retacrit was well tolerated by patients in the study. Full results of the study, called ORHEO, were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 3.

Retacrit, a recombinant human erythropoietin, or an “EPO biosimilar,” was launched in Europe in early 2008. Retacrit is used to treat symptomatic anemia associated with chronic renal failure in adult and pediatric patients and anemia in adult patients receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma.

Study Results
This European prospective, observational study included 2,310 patients with solid tumors, lymphomas or myelomas. The majority of patients (>80 percent) enrolled in this study achieved a pre-defined hemoglobin (Hb) response with Retacrit in a real-world clinical setting.   Retacrit was well tolerated in this study with an overall rate of thrombotic events at 3.5 percent. In this observational study, no epoetin alfa biosimilar-related deaths were reported.

“Patients in the study showed a very good rate of response to Retacrit and tolerated it well,” said Dr. Elisabeth Luporsi-Gely , of ICL Alexis Vautrin, Vandoeuvre-les-Nancy, France, and one of the study’s principal investigators. “This is the first post-marketing observation study conducted in France for a biosimilar, and the results reinforce why there is a growing acceptance of biosimilars. The introduction of biosimilars has offered new options for patients and has helped bring cost savings to the healthcare system.”

In addition to the results from this study, several Hospira-related studies were presented at the ASCO Annual Meeting, including:

  • Young-Hyuck Im, Petro Odarchenko, Daniela Grecea, Dmitry Komov, et al: Double-blind, randomized, parallel group, phase III study to demonstrate equivalent efficacy and comparable safety of CT-P6 and trastuzumab, both in combination with paclitaxel, in patients with metastatic breast cancer (MBC) as first-line treatment; Presented at 2013 ASCO Annual Meeting
  • Jean-Emmanuel Kurtz, Pierre-Louis Soubeyran, Mauricette Michallet, Elisabeth Luporsi-Gely ;Epoetin biosimilars in the management of chemotherapy-induced anemia in elderly patients: A subanalysis of the ORHEO study; Poster session presented at 2013 ASCO Annual Meeting
  • Manuel Constenla, Jorge Aparicio, M.Auxiliadora Gomez, Cristina Gravalos Castro, Miriam Lopez-Gomez, Jose Luis Manzano, Maria Dolores Pineda, Juana Maria Cano, Isabel Sevilla,  et al; Tolerability of raltitrexed when it is used in monotherapy and in combination with oxaliplatin (TOMOX) as advanced colorectal cancer treatment in normal clinical practice; Poster session presented at 2013 ASCO Annual Meeting

Hospira’s second marketed biosimilar product is Nivestim, a biosimilar version of filgrastim, a recombinant Granulocyte Colony-Stimulating Factor (G-CSF), used for a condition known as neutropenia in which the body makes too few infection-fighting white blood cells. Nivestim entered the European market in 2010 and the Australian market in 2011.

Hospira’s broad biosimilars pipeline, including products it shares with South Korean partner Celltrion, is comprised of 11 products and is one of the largest in the industry. In 2012, Hospira filed for European approval of a biosimilar version of infliximab, a treatment for auto-immune diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriasis. Hospira also has a biosimilar version of an oncolytic, trastuzumab, in clinical studies.

Hospira is currently conducting a Phase III U.S. clinical trial program for its U.S. epoetin product, which is being developed as a biosimilar to erythropoietin alpha in patients with renal (kidney) dysfunction who have anemia.


Source: Hospira press release

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