Earlier this year, Health Canada announced that it would not be using four-letter suffixes adopted by the U.S. Food and Drug Administration (FDA) for naming biosimilars and biologics. Those suffixes have caused considerable disagreement and debate in the pharmaceutical industry.
While a controversy over a four-letter suffix may seem minor, it actually has important implications for patient safety and pharmacovigilance, both of which are extremely important issues. Let’s take a closer look at why these suffixes are causing so much controversy and what Health Canada’s announcement means.
As Clinical Research College Students Know, Biologics and Biosimilars Aren’t Exactly the Same
To understand this naming controversy, it’s important to understand the difference between biologics and biosimilars. A biologic is a drug that is in some way derived from biological sources, such as vaccines, gene therapies, blood, and tissues. Biosimilars are an almost identical copy of a biologic whose patent has lapsed. However, because biologics have a highly complex and sensitive molecular structure, a biosimilar is never exactly the same as the original biologic.
Biosimilars are required to have the same quality and therapeutic effects as the original biologic. However, regulators realize that minor differences between the biologic and biosimilar could potentially lead to unexpected adverse events. If that happens, they need to be able to distinguish the biosimilar from the biologic. For example, if you become a pharmacovigilance or drug safety officer after clinical research college, you will want to know whether the patient’s adverse event was caused by a biologic, a biosimilar, or both. Currently, that can be a bit difficult because an increasing number of biologics and biosimilars share the same non-proprietary name.
Regulators Debate Adding Suffixes to Distinguish Biologics from Biosimilars
That’s why the FDA devised a naming convention whereby a four-letter meaningless suffix would be added to the non-proprietary names of both biologics and biosimilars. For example, Zarxio, which is manufactured by Sandoz, is a biosimilar of Neupogen, which is manufactured by Amgen. Both drugs have the non-proprietary name filgrastim. To distinguish the two, the FDA has proposed adding different suffixes to each non-proprietary name. Neupogen’s non-proprietary name would become “filgrastim-jcwp” and Zarxio’s would become “filgrastim-bflm.”
However, the change has provoked controversy. Critics say the new naming conventions have been applied inconsistently, with more biosimilars than biologics so far receiving the suffixes. Critics also contend that the suffixes will cause confusion for health care providers, who may wonder whether the four letters—which are intentionally meaningless—might actually carry important product or safety information. This could lead to pharmacovigilance concerns, which is a topic covered in clinical research programs, as health care providers may be more prone to make a drug administration error if they are confused about the suffixes.
Health Canada announced that it would not be using the suffixes and cited the potential for confusion as a concern. Furthermore, the agency contends there is already sufficient information to distinguish a biologic from a biosimilar. For instance, health care providers have been advised to use both the product’s brand name and non-proprietary name to distinguish between a biosimilar and biologic. The agency also noted that all drugs in Canada, including biologics and biosimilars, are already assigned a unique Drug Identification Number (DIN), which includes information about the drug’s brand name, manufacturer, active ingredients, strength, dosage form, and route of administration. Taken together, this information should be enough to identify a biologic from a biosimilar.
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