Daniella Latham

As one of Shakespeare’s most famous characters asked, "What’s in a name?”, the answer in the biosimilar industry is clear: nomenclature is critical for identification purposes.

The World Health Organization (WHO) has proposed a “biological qualifier” for tracking biologic products to institute a global approach for patient safety and traceability. As the WHO explains in its proposal, the naming approach “is designed to provide a uniform global means of identification to avoid the proliferation of differing national schemes” — meaning a unified naming system.

But not all stakeholders agree this is the most effective way to move forward.

In 2015, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation & Research and Dr. Karen Midthun, Director of FDA’s Center for Biologics Evaluation and Research, proposed a draft guidance requesting reference products and biosimilars have nonproprietary names (proper names) that share a core drug substance name and for each product, a unique FDA-designated suffix composed of four lowercase letters. For interchangeable biological products, public feedback about whether the nonproprietary name for a product should include a distinct suffix, or share the same suffix as its reference product.

The proposed naming convention seeks to address two main issues: To help prevent accidental substitution of biological products that are not determined to be interchangeable by the FDA, which could lead to medical error; and to support safety monitoring of all biological products after they are on the market with more accurate tracking of the usage of biological products in multiple care settings: outpatient, hospital, and pharmacy.

The FDA’s draft guidance on naming, according to the FTC, could “

result in physicians incorrectly believing

 that biosimilars' drug substances differ in clinically meaningful ways from their reference biologics' drug substances.” The FTC suggested the FDA's proposal would inhibit competition intended to lower prices on biologic medications; many are the most expensive types of drugs in the marketplace. 

The suggestion was that the FDA could track drugs by their brand or trade name instead of a new nonproprietary naming system. The FTC’s rationale is to employ a post-market tracking system and minimize mistakes made when entering information, such as the wrong suffix for a specific drug. 

 along with the Hematology/Oncology Pharmacy Association, among pharmacist members, where it offered insight into how the profession feels about naming conventions for biosimilars. Among 781 poll-takers, the clear favorite was the nonproprietary proper name with a designated suffix. However, when asked about their level of confidence when dispensing a biosimilar instead of the reference biologic, pharmacists were more sure when the products had the same nonproprietary name in common.

The poll also probed attitudes regarding regulations requiring pharmacists to submit postdispense notifications. The results suggest the obligations placed on pharmacists could deter some from dispensing interchangeable biologics, although this hesitance would be mitigated if the biologics were to share the same nonproprietary name as the reference biologic.

Amgen’s executive director of global operations, Gino Grampp, says his company supports policies that ensure biologicals, both originators and biosimilars are prescribed, dispensed and monitored appropriately. “We are very concerned about a tendency to move towards International nonproprietary names (INN)-based prescribing and dispensing by INN, and towards INNs being used in adverse event reports” for biologicals. Grampp also said that clear identification and traceability was “a good way of achieving this. So we support measures to promote product- specific traceability in health records and pharmacovigilance reports, and we believe that identifiers like the BQ or the (US) FDA’s four-letter suffix will help.”

The European Biosimilars Group (EBG), part of the European Generic and Biosimilar Medicines Association, openly challenged the proposed biosimilars naming convention in a policy document presented at the WHO consultation meeting in April 2015, “The current system works well; the introduction of a special system for a specific class of products disrupts this well-working unified system,” said the EBG. “Physicians and pharmacists will be confused as to what to do with the new, unknown identifier. This increases the risk of prescription errors, dispensing errors, medication errors and adverse reaction reporting errors.” The 

 can only increase the risk of error or hinder pharmacovigilance.

The US Generic Pharmaceutical Association (GPhA) is also not clear why the addition of a BQ to the INN would provide any additional value as it thinks the current INN naming system is simple and should not be changed, according to a WHO document published in March 2015. The GPhA also thinks the proposed BQ scheme should not have a manufacturing site designation, but if a modifier is to be used, the clearest format would be the marketing authorization holders’ (MAH’s) name.

For nearly a decade, BIO has advocated actively for a nonproprietary naming convention that ensures all biological products are distinguishable, and believes that a distinguishable nonproprietary naming convention would best facilitate pharmacovigilance, ensure accurate attribution of adverse events to the correct product, prevent inappropriate substitution and unintended switching, and support tracing of products in the event of a recall. In short, BIO strongly believes that distinguishable nonproprietary names enhance patient safety.

A date has not yet been set for the FDA’s formal ruling on biosimilar naming conventions in the US—but clearly the debate will continue among the key industry stakeholders until the decision is finalized.

Articles

As one of Shakespeare’s most famous characters asked, "What’s in a name?”, the answer in the biosimilars industry is clear: nomenclature is critical for identification purposes.

Daniella Latham

Naming Biosimilars: The Debate Rages On