Hope for Greater Access for Patients to Biosimilar Medicines

Hospira 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, 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 6 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.

• 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, 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 7 years.