LAKE FOREST, Illinois, April 13, 2015 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, said at the World Health Organization (WHO) in Geneva, Switzerland, today that it is essential for biosimilar drugs to be given the same nonproprietary names as original biologics to ensure that patients receive the full benefit of greater access and lower costs that these medicines can bring.
Lisa Skeens, Ph.D., global vice president for regulatory affairs, Hospira, spoke at the WHO's 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva and made the following points:
- Europe has approved biosimilars with the same nonproprietary names as their reference biologics for more than six years in a system that has proved effective
- Biosimilars have been successfully tracked in the marketplace using their brand name and other identifiers currently in place for product recognition, meaning a separate nonproprietary name isn't necessary for keeping track of biosimilars once they're on the market
- The U.S. Food and Drug Administration (FDA) has taken a major step toward providing patients with improved choices for biologic therapies by approving the first-ever biosimilar medicine in the United States on March 6, but the full promise of that decision will not be realized if patients and healthcare providers are confused by needless variations in nonproprietary names
- Different nonproprietary names for a biologic and the biosimilar medicine patterned on that biologic could create confusion among the clinicians who rely on international and local standards to fill prescriptions for patients, potentially resulting in safety and medication access issues
- Recently the Therapeutic Goods Administration (TGA) in Australia announced that they too are reviewing their position on biosimilar naming, thus paving the way for greater access and cost savings for patientsi
Dr. Skeens, who spoke at WHO on behalf of the Generic Pharmaceuticals Association (GPhA), made reference to a policy paper on biosimilars naming, authored by Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira, in which he draws on his own experience as a physician prescribing medications and Hospira's experience in biosimilars for the past seven years.
Biosimilars are biologic medicines produced at a more affordable cost to both the healthcare system and patients. In Europe, biosimilars have helped lower costs by 20 percent to 30 percent.ii It's estimated that biosimilars could save the U.S. healthcare system $20 billion annually.iii The U.S. biosimilars market is posed for rapid growth with the approval of the first-ever biosimilar in the United States on March 6, 2015.
Hospira is the first U.S. company to sell biosimilars in Europe, launching its erythropoietin product, Retacrit™ in early 2008. It also sells Nivestim,™ a filgrastim biosimilar, in Europe and Australia, and in 2013 received European approval for Inflectra,™ its biosimilar version of infliximab. Hospira has submitted to FDA for approval its U.S. epoetin product, which is a biosimilar to erythropoietin alfa.
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.
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A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or Hospira's future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these words or other similar terms or expressions that concern Hospira's expectations, strategy, plans or intentions. Forward-looking statements in this press release include, but are not limited to the outcome of naming decisions related to biosimilars, the pace of growth of the U.S. biosimilars market and the action of competitors. Hospira's expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, challenges inherent in creating and developing compounds and product candidates and economic, competitive, governmental, regulatory, legal, supply and other factors. Information on these and additional risks affecting Hospira's business and operating results are more fully discussed in the section entitled "Risk Factors" in its most recently filed annual report on Form 10-K. The forward-looking statements in this press release are based on information available as of the date hereof, and Hospira disclaims any obligation to update any forward-looking statements, except as required by law.
i Therapeutic Goods Administration. https://www.tga.gov.au/book/naming-conventions-biosimilars.
ii IMS Intelligence Incorporated. Shaping the biosimilars opportunity: A global perspective on the evolving biosimilars landscape. 2011 December. Section 1, Page 2.
iii "New Grant Thornton Study Show Immediate Need for Biosimilar Competition." Generic Pharmaceutical Association. 1 February, 2013. http://www.gphaonline.org/gpha-media/press/gpha-press-granthornton.
SOURCE Hospira, Inc.