by Amanda Conschafter, blog editor
After years of international debate, the World Health Organization has issued its final proposal embracing distinct names for biological medicines, including biosimilars. The organization opts for four-letter biological qualifiers to follow biological medicines’ international nonproprietary name. The approach acknowledges patient and advocates’ concerns that distinct names be applied to ensure clarity, patient safety and the ability to track adverse events to their source.
Background on Naming
Prescription medications typically carry two names: the brand name, selected by the manufacturer, and the non-proprietary name. Health care professionals generally refer to medications by their non-proprietary names.
With traditional, synthetic medications, both the original drug and the generic follow-on medications carry the same non-proprietary name. Because biosimilars are not generic forms of their biological reference products, though, biological qualifiers will preserve important distinctions among these medicines.
Final Biological Qualifier Approach
According to WHO, biological qualifiers will consist of four random consonants and, optionally, an additional two digits. The qualifier will follow a biological medication’s nonproprietary name, acting as a suffix, and may take one of three forms:
- Four letters
- Four letters followed by two digits
- Two letters, two digits and two letters
Qualifiers are assigned through the WHO’s INN Secretariat and can be given either retrospectively or prospectively, the organization explains.
Impact on Patient Safety
Health care providers and advocates have argued that distinct names are essential to preventing confusion about which therapy a physician prescribes and which the pharmacist dispenses. Though biosimilars can be highly similar and may offer comparable results for patients, physicians should know which of these powerful and complex therapies their patient is taking.
Distinguishable names are particularly crucial in the case of adverse events. Pharmacovigilance – tracking adverse events and tracing them to their source – demands that a patient’s reaction can be quickly and accurately traced to its source.
Implications for U.S. Regulators
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.” The Food and Drug Administration proposed a similar system of randomly generated four-digit qualifiers in its August 2015 proposed rule. The FDA’s final rule on naming is forthcoming.