A biosimilar is a biological medical product that is manufactured by a different company but almost identical to an original product. These are officially approved versions that are generally produced after the patent expires on the original product. These products are typically molecularly complex and manufacturing differences can be problematic. Because of the increased potential for different effects between a biosimilar and the original biologic compound, there are specific regulations which let doctors and pharmacists know in greater detail how comparable two biological products are.
In order to be classified as a biosimilar, a product must be approved by the FDA as being highly similar to a previously FDA approved biological product. This process requires the manufacturer of the biosimilar to show clinical proof that there is no meaningful difference between the biosimilar and the reference product. A biosimilar has a range of differences which are allowed because the product is being created from living organisms.
Interchangeable Biological Product
In order to be classified as an interchangeable biological product, the manufacturer must go through the same requirements to be granted biosimilar status but they must also provide clinical proof that their product will work equally well for any patient. They must further prove that there is no risk to the patient if they are alternatively administered the original product and the product seeking interchangeable status. Thus far, the FDA has only approved biosimilar status for two products and neither has received interchangeable status.
A recent survey indicated that the majority of pharmacists were more comfortable filling a prescription for a biosimilar if the chemical name for the drug was the same as that of the original product. This was found to be more important than the commercial name. More than 20 states allow pharmacists to substitute biosimilar products without consulting the prescribing physician. The way the biological products are named then potentially becomes a contributing factor to how often they are used.
One of the key advantages a biosimilar product has over the original is affordability. The makers of generic medications and biosimilar products do not have to recoup an investment in the development and testing of the drug they are creating. This usually allows them to offer it for substantially less than the original manufacturer and can save patients and healthcare facilities a great deal of money.
The question is, should the name of a product matter more than the safety and efficacy? Considering how drastically the naming conventions are set to change it is important pharmacists be aware of their own potential biases regarding the names of biosimilar products so they are more consciously aware of their motivations when choosing whether or not to use them as a substitute.