Hospira calls for biosimilars to have same name as biologicals


Different names for a biologic and the biosimilar medicine patterned on that biologic could create confusion among clinicians

Biosimilar drugs should be given the same international non-proprietary names (INNs) as original biologics, says Hospira, a US provider of injectable drugs and medical devices.

Speaking at the World Health Organization's Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances in Geneva, Lisa Skeens, Hospira's Global Vice President for Regulatory Affairs, said Europe has approved biosimilars with the same non-proprietary names as their reference biologics 'for more than six years in a system that has proved effective'.

She added that biosimilars have been successfully tracked in the marketplace using their brand name and other identifiers currently in place for product recognition, and a separate non-proprietary name is not necessary.

The US Food and Drug Administration (FDA) approved the first biosimilar medicine in the US on 6 March, but Skeens said the full promise of that decision 'will not be realised if patients and healthcare providers are confused by needless variations in non-proprietary names'.

A separate non-proprietary name is not necessary

'Different non-proprietary 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,' she said.

The Therapeutic Goods Administration (TGA) in Australia recently announced that it is reviewing its position on biosimilar naming.

Biosimilars are biologic medicines produced at a more affordable cost to both the healthcare system and patients. In Europe, they have helped lower costs by 20–30%. It is estimated that biosimilars could save the US healthcare system US$20bn annually.

Hospira is the first US company to sell biosimilars in Europe, launching its erythropoietin product, Retacrit in 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.

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The company has submitted its US epoetin product, which is a biosimilar to erythropoietin alfa, to the FDA for approval.