Matthew Burnette, PharmD | Director of Clinical Operations
In the last few years, there have been a number of generic medications released on the market under a different name than the brand but not the chemical name. This can lead to confusion for nursing and medication technicians that administer these drugs in the long-term care sector. Let’s begin by discussing brand versus generic medications and then discuss branded generics and biosimilars.
Brand name medications versus generics. How does that process work? For a typical brand-name medication, a drug manufacturer funds the research and development of a potential drug product with the intention of being able to sell it later on. In order to gain approval to sell their medication, drug manufacturers must complete and file an NDA (New Drug Application) with the FDA (Food and Drug Administration). This application contains animal studies and human clinical trials that will be used to answer the FDA’s “key decisions” and tell the drug’s entire story.
Generic medications are manufactured by a company other than the original one using an ANDA (abbreviated new drug application). This makes them cheaper because the company does not have to pay for all of the testing and trials that the original manufacturer did. If a company wants to utilize a recognizable name, instead of the hard to pronounce chemical name, they are able to choose a name then. This is beneficial for “brand recognition” in a competitive market. Wixela Inhub is a good example of this as it is generic for Advair, but carries a completely different name while containing the exact same ingredients.
Brand name and generic medications are considered “AB-rated” and are thus bioequivalent. This meaning that they can be substituted for one another at the pharmacy level automatically with no prescriber approval. AB ratings become tricky when you discuss products such as biosimilars. These are medications that are more complex and go through a different type of licensure. Medications can be considered “biosimilar” if they have the same effect as the original biologic product and are “highly similar” with only minor differences in their inactive components. Examples of biosimilar agents would be Lantus and Basaglar. Both of these medications are insulin glargine and have the exact same effect of lowering blood sugar, however, they are not generic for one another and cannot be substituted without prescriber authorization. The FDA approved the very first generic biologic medication last week, Semglee (insulin glargine – yfgn). This product is be AB-rated with Lantus and can be interchanged at the pharmacy without contacting the prescriber.
This is a brief review of the differences between brand, generic, branded generic, and biosimilar medication names. For more information please contact me or any of our friendly Gayco pharmacy representatives.