Many of today’s pharmacological breakthroughs are biological products. These products are created from a variety of living organisms such as animals, yeast, bacteria, or humans. These products have more complex structures and contain larger molecular mixtures than conventional drugs. Conventional drugs are derived from chemical substances which are easily identifiable. Biological products are far more complex which are harder to characterize and identify.
Biosimilars are products that are found to be substituted with a previously FDA approved biological product. These products have no meaningful clinical difference in terms of efficacy and safety from the approved product. The biosimilar may only contain minor differences in the inactive components.
Products that have received the designation as being an interchangeable biological product have met further standards. This designation allows the interchangeable biological product to be substituted for the referenced product by pharmacists without consulting the health care provider who prescribed the original product.
The rules regarding what may be considered a biosimilar and an interchangeable biological product were put forth in the Patient Protection and Affordable Care Act of 2010.
Naming of Biological Products
The FDA released the Nonproprietary Naming of Biological Products in order to help limit inadvertent substitution which could lead to medication errors of products that have not been deemed interchangeable. Further, it was an attempt to provide support in monitor and track all biological products once they enter the market. The guidance proposed adding a random suffix to the name of the product to distinguish it from the original product. The guidance of whether or not to add a unique suffix to interchangeable products has been less clear and is the subject of more debate amongst industry leaders.
Many industry leaders are advocating the plan put forth by the World Health Organization for the naming of biosimilar and interchangeable products. The idea that the suffix should be meaningful rather than random has broad support from both physicians and pharmacists. It is believed making the suffixes meaningful will make it easier for physicians, pharmacists, and patients to identify the medications they are being given. The hope is this will make it easier to track the drugs given, and more efficiently limit medication errors.
The eventual decision by the FDA on how to name biosimilar and interchangeable biological products will have far reaching consequences on the ability of healthcare providers to choose and dispense appropriate medications. Randomized names will likely be more difficult for providers to remember and less useful in pharmacovigilance endeavors. The ability to easily and effectively relate adverse effects to the appropriate biologic or biosimilar product is paramount to patient safety.