Hope for greater access for patients to biosimilar medicines

April 14, 2015 8:24 AM

Hospira, Inc., said at the World Health Organization (WHO) in Geneva, Switzerland, 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 patients.

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. It’s estimated that biosimilars could save the U.S. healthcare system $20 billion annually. 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.

Source: Hospira press release

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