Data presented at the National Kidney Foundation (NKF) Spring Meeting;
Single and multiple-dose pharmacokinetic and pharmacodynamic (PK/PD) studies support biosimilar application for Epoetin Hospira in the United States
DALLAS, TX, USA I March 27, 2015 I Hospira, Inc. (NYSE: HSP), a global leader in biosimilars and the world’s leading provider of injectable drugs and infusion technologies, presented two studies that support an evaluation of biosimilarity of its proposed biosimilar, Epoetin Hospira, with the U.S. Food and Drug Administration (FDA) conditionally approved name of RETACRIT™, compared to the reference product, Amgen’s EPOGEN™ (epoetin alfa). These study data were presented at the National Kidney Foundation (NKF) spring meeting in abstracts titled “PK/PD Equivalence of Epoetin Hospira and EPOGEN Following Single Subcutaneous Doses to Healthy Subjects,” and “Epoetin Hospira and EPOGEN PK/PD Equivalence Following Multiple Subcutaneous Doses to Healthy Subjects.”
“Both studies are consistent with the assessment of biosimilarity between the reference product, EPOGEN, and the Hospira proposed biosimilar, Epoetin Hospira,” said Stan Bukofzer, M.D., corporate vice president and chief medical officer, Hospira. “These studies contribute to the demonstration of biosimilarity and are an integral part of the overall biosimilar development program.”
Study Description
Both randomized, open-label, active-controlled studies evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Epoetin Hospira compared to Amgen’s reference product, EPOGEN (epoetin alfa), administered by subcutaneous injection in healthy volunteers. One study evaluated a single dose of 100 Units/kg, and the other study evaluated multiple doses of 100 Units/kg administered three times per week for a total of four weeks. The studies included measuring the effect of well-established PD clinical markers of reticulocyte count and hemoglobin, which were equivalent between Epoetin Hospira and EPOGEN in both studies. These markers were selected because they are directly reflective of the mechanism of action of epoetin alfa and, based on literature, are known to directly correlate with clinical effects.
About Epoetin Hospira
Epoetin Hospira is a proposed biosimilar medication to the reference products, Amgen’s EPOGEN (epoetin alfa) and Janssen’s PROCRIT (epoetin alfa). The Biologics License Application for Epoetin Hospira includes a comprehensive data package inclusive of foundational analytical biosimilarity data, nonclinical data, clinical pharmacology, and clinical efficacy and safety data, and was submitted to the U.S. Food and Drug Administration (FDA) on Dec. 16, 2014, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Hospira received notification of FDA filing acceptance on Feb. 11, 2015.
About Hospira Biosimilars
Hospira’s global biosimilar pipeline is one of the largest in the industry, comprised of a combination of biosimilars being developed in-house and biosimilars from Hospira’s partners. Hospira is one of the first companies to submit regulatory applications for biosimilars to the FDA, with two applications already submitted, one through its partnership with Celltrion, a South Korean company that specializes in monoclonal antibodies. Hospira is the only U.S.-based company with biosimilars approved in Europe, including Retacrit™ (epoetin zeta), which was launched in Europe in early 2008, and Nivestim™ (filgrastim), which entered the European market in 2010 and was approved in Australia in 2011. In 2013, Hospira received European Medicines Agency (EMA) approval for Inflectra™ (infliximab), the first biosimilar monoclonal antibody approved in Europe.
About Hospira
Hospira, Inc. is the world’s leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill. Learn more at www.hospira.com.
For more information, please visit www.hospira.com/biologics or www.biosimilarfacts.com.
SOURCE: Hospira
Post Views: 94
Data presented at the National Kidney Foundation (NKF) Spring Meeting;
Single and multiple-dose pharmacokinetic and pharmacodynamic (PK/PD) studies support biosimilar application for Epoetin Hospira in the United States
DALLAS, TX, USA I March 27, 2015 I Hospira, Inc. (NYSE: HSP), a global leader in biosimilars and the world’s leading provider of injectable drugs and infusion technologies, presented two studies that support an evaluation of biosimilarity of its proposed biosimilar, Epoetin Hospira, with the U.S. Food and Drug Administration (FDA) conditionally approved name of RETACRIT™, compared to the reference product, Amgen’s EPOGEN™ (epoetin alfa). These study data were presented at the National Kidney Foundation (NKF) spring meeting in abstracts titled “PK/PD Equivalence of Epoetin Hospira and EPOGEN Following Single Subcutaneous Doses to Healthy Subjects,” and “Epoetin Hospira and EPOGEN PK/PD Equivalence Following Multiple Subcutaneous Doses to Healthy Subjects.”
“Both studies are consistent with the assessment of biosimilarity between the reference product, EPOGEN, and the Hospira proposed biosimilar, Epoetin Hospira,” said Stan Bukofzer, M.D., corporate vice president and chief medical officer, Hospira. “These studies contribute to the demonstration of biosimilarity and are an integral part of the overall biosimilar development program.”
Study Description
Both randomized, open-label, active-controlled studies evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Epoetin Hospira compared to Amgen’s reference product, EPOGEN (epoetin alfa), administered by subcutaneous injection in healthy volunteers. One study evaluated a single dose of 100 Units/kg, and the other study evaluated multiple doses of 100 Units/kg administered three times per week for a total of four weeks. The studies included measuring the effect of well-established PD clinical markers of reticulocyte count and hemoglobin, which were equivalent between Epoetin Hospira and EPOGEN in both studies. These markers were selected because they are directly reflective of the mechanism of action of epoetin alfa and, based on literature, are known to directly correlate with clinical effects.
About Epoetin Hospira
Epoetin Hospira is a proposed biosimilar medication to the reference products, Amgen’s EPOGEN (epoetin alfa) and Janssen’s PROCRIT (epoetin alfa). The Biologics License Application for Epoetin Hospira includes a comprehensive data package inclusive of foundational analytical biosimilarity data, nonclinical data, clinical pharmacology, and clinical efficacy and safety data, and was submitted to the U.S. Food and Drug Administration (FDA) on Dec. 16, 2014, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Hospira received notification of FDA filing acceptance on Feb. 11, 2015.
About Hospira Biosimilars
Hospira’s global biosimilar pipeline is one of the largest in the industry, comprised of a combination of biosimilars being developed in-house and biosimilars from Hospira’s partners. Hospira is one of the first companies to submit regulatory applications for biosimilars to the FDA, with two applications already submitted, one through its partnership with Celltrion, a South Korean company that specializes in monoclonal antibodies. Hospira is the only U.S.-based company with biosimilars approved in Europe, including Retacrit™ (epoetin zeta), which was launched in Europe in early 2008, and Nivestim™ (filgrastim), which entered the European market in 2010 and was approved in Australia in 2011. In 2013, Hospira received European Medicines Agency (EMA) approval for Inflectra™ (infliximab), the first biosimilar monoclonal antibody approved in Europe.
About Hospira
Hospira, Inc. is the world’s leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill. Learn more at www.hospira.com.
For more information, please visit www.hospira.com/biologics or www.biosimilarfacts.com.
SOURCE: Hospira
Post Views: 94
