Specialty Pharma Journal Specialty, Precision & Technology
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S. “As …
Tag Archives: hospira
May, 2018
October, 2016
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7 October
Pfizer to Sell Infusion Business to ICU Medical in $1 Billion Deal
ICU Medical Inc. (NASDAQ:ICUI) and Pfizer Inc. (NYSE:PFE) today announced that they have entered into a definitive agreement under which ICU Medical will acquire all of Pfizer’s global infusion therapy business, Hospira Infusion Systems (HIS), for $1 billion in cash and stock. The Hospira Infusion Systems business includes IV pumps, solutions, and devices …
August, 2015
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21 August
TGA Approves Hospira’s mAb Biosimilar
MELBOURNE, Australia, Aug. 19, 2015 /PRNewswire/ — Hospira today announced that InflectraTM (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia. This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (PBS). …
June, 2015
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11 June
Hospira Presents Positive Results for its Biosimilar Monoclonal Antibody Inflectra
Biosimilars drugmaker Hospira, Inc. announced results showing patients with rheumatic diseases experienced comparable clinical effectiveness and safety after switching from Janssen’s Remicade to Hospira’s Inflectra, the first biosimilar monoclonal antibody, which received approval from the European Commission (EC) in 2013. The Lake Forest-based company presented the data at the European …
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2 June
Brazil Approves Hospira’s Remsima, a Biosimilar Version of Remicade
The National Health Surveillance Agency in Brazil, ANVISA, has approved the first biosimilars monoclonal antibody for use in the country. Leading biosimilars drugmaker Hospira, Inc. announced that its partner Celltrion has received approval for its Remsima (infliximab) for use in Brazil. The drug is the first biological medication approved by …
April, 2015
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29 April
Hospira Highlights the Importance of Extrapolation for Successful Development of Biosimilars Market
Hospira highlighted the importance of extrapolation in bringing biosimilars to patients at a medical conference last week. The company encouraged regulators to continue to adopt important scientific and clinical concepts of extrapolation, noting that Europe has 21 European Medicines Agency (EMA) approved biosimilars and the US Food and Drug Administration …
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13 April
Hospira Outlines Importance of Biosimilars Having Same Nonproprietary Names as Original Biologics
At the World Health Organization (WHO) in Geneva, Switzerland, Hospira, Inc. said that it is essential for biosimilar drugs to be given the same nonproprietary names as original biologics. Hospira, the world’s leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, said that biosimilars should …
March, 2015
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27 March
Hospira Presents Data Demonstrating the Biosimilarity Between Amgen’s Epogen and Hospira’s Proposed Biosimilar
Hospira, Inc. presented two studies supporting biosimilar application for Epoetin Hospira in the US. Hospira, a global leader in biosimilars and the world’s leading provider of injectable drugs and infusion technologies, presented two studies at the National Kidney Foundation (NKF) Spring Meeting. The two presentations were “PK/PD Equivalence of Epoetin …
February, 2015
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26 February
FDA Postpones Advisory Meeting on Biosimilar Copy of Remicade
The US Food and Drug Administration (FDA) has postponed an advisory committee meeting to consider approval of Hospira and partner Celltrion’s biosimilar of Remicade. The agency said that it wants more time to review the Biologics License Application (BLA) for CT-P13, a proposed biosimilar to Janssen Biotech Inc.’s Remicade (infliximab), …
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25 February
Celltrion and Hospira Launch Biosimilars of Remicade in Major European Markets
Partners Hospira, Inc. and Celltrion Healthcare have launched a biosimilar version of Johnson & Johnson’s autoimmune drug Remicade across major European markets. Together, the companies are launching their biosimilar products in twelve European markets, including Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the UK. …