Reading the label: The importance of naming biologic medicines

Reading the label: The importance of naming biologic medicines

Accurate communication between primary healthcare providers, nurses, pharmacists and patients is one of the tenets of quality care. Pharmaceutical naming, using brand names (the names given to products by manufacturers) and nonproprietary names (the names used to describe a medication’s active ingredients) is one of the pillars of this communication model— one that ensures patients receive the medicine chosen by their physician.

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medicine that is similar but not identical to an original product that is manufactured by a different company. Biosimilars present a unique situation when it comes to naming, but after several years of discussion, the international community is now closer to agreeing on a labeling standard.

At the centre of the debate are the issues of safety and efficacy, and the concern that biosimilar medicines with similar nonproprietary names may cause unintentional switching or substitution, which may have significant — and preventable — consequences relating to the quality of patient care and the traceability of adverse events.

When it comes to conventional pharmaceuticals, the system of assigning a brand name and a nonproprietary name works well, considering that generic versions of synthetic drugs are essentially identical to their brand-name counterparts.

In the realm of biologics, however, this system is insufficient, since no two biologic products are identical, and very small differences in complex proteins can behave differently in the body — resulting in different outcomes.

“It’s so important for biosimilars to be distinguishable from their originator biologic due to the difference in active ingredients and the potential in effects on patients,” said Jackie Manthorne, President and CEO of the Canadian Cancer Survivor Network.

It’s so important for biosimilars to be distinguishable from their originator biologic due to the difference in active ingredients and the potential in effects on patients. – Jackie Manthorne, President and CEO of Cancer Survivor Network

In a scenario where a physician has decided a particular biologic product is best for her patient, and writes a prescription using the nonproprietary name alone, it’s entirely possible that the patient may receive the biosimilar product with the same nonproprietary name at the pharmacy — an unintended substitution. In the case of a refill, the patient may not get the same drug he was originally given — leading to an inadvertent switch. In either situation, it may be impossible for the physician or the patient to even be aware of such incidences. If a patient is experiencing unusual side effects, it’s possible the resulting report may not reflect the correct product.

Individual national health authorities may have their own effective system for labeling. But with manufacturing occurring on a global scale, and with some manufacturers choosing to use different brand names for their medicines in different countries, it follows that a naming and labeling standard for biologic medicines should be one that can be applied worldwide.

“Healthcare systems globally must ensure all biologic medicines, including biosimilars, can be rapidly and accurately identified by national regulators, healthcare providers and patients,” said Manthorne. “Distinguishable names for all biologics will help strengthen the accuracy of tracing via post-marketing safety monitoring systems.”

The World Health Organization (WHO) maintains the International Nonproprietary Names (INN) database, and has been leading the discussion in creating a solution to ensure every biologic medicine, be they originator or biosimilar, is traceable and individually identifiable across the globe.

Their solution involves adding a unique randomized suffix, called the Biologic Qualifier (BQ), to the end of each distinct biologic medicine name. Adopting the BQ would be entirely voluntary, but as already demonstrated, there are convincing reasons for international health authorities to apply the convention. Though, there is still some debate as to how to best assign these BQs. Some advocate bodies have maintained that the suffix should be memorable in order to help physicians remember which product is which.

Every member of a patient’s healthcare team should be equally diligent when it comes to identifying the correct biologic medicine prescribed. While completely unintended, mix-ups in biologic and biosimilar medicines can result in inaccurate reporting and put patient safety at risk. Adopting a universal naming convention may help to eliminate confusion in a system where accuracy is undoubtedly tied to the quality of patient care.

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