The Era of Biosimilars

Now that the FDA has approved the first biosimilar in the United States, pharmacists will be dealing with new opportunities to save patients money on their drug therapy costs. This opportunity will likely develop slowly as the profession, the FDA, and legislators deal with all the issues involved. What these products should be called is one issue. Biosimilars are biologics made from living cells (large-molecule drugs), and unlike generic drugs (small-molecule drugs), which can be exact copies of the branded product, biosimilars are similar to but not identical copies of the branded product.

Some pharmacy and related groups are urging the FDA to forgo allowing different names for biosimilars and biologics. This thinking is based on the idea that product substitution will be easier if the nonproprietary name is the same; this should also enhance patient confidence in the products. Allowing for different names would lead to safety issues and confuse health care providers, the groups suggest.

The other side sees biosimilars and other biologics as highly complex drugs that can be life-saving therapies—but therapies that nonetheless carry the risk of immunogenicity that could lead to a fatal reaction. Since these products are not identical, their names should reflect that they are different products. The thinking behind this is that clarity in the names will enable better safety monitoring of adverse events.

Both sides make good points. My position, however, falls on the side of not allowing or promoting different names. Although these products are new to the US market, there is already much international experience with them. We should be able to use this international experience to guide the labeling decision in the United States. When generic products began to explode into the US market, there were efforts by some to cause confusion about the products’ safety and quality. It would be helpful if we could prevent this from recurring as biosimilars become more prevalent; the decision on what to name them will help to limit any confusion. That is why I favor not allowing different names for similar products. The FDA should be resolving the naming of biosimilar products soon.

As the drug experts on the health care team, pharmacists should become knowledgeable about this practice activity. Many continuing education programs are now available to help you become familiar with this new opportunity. Consumers will be looking to you to guide them on making wise choices about substituting biosimilar products.

Mr. Eckel is professor emeritus at the Eshelman School of Pharmacy, University of North Carolina at Chapel Hill. He is also emeritus executive director of the North Carolina Association of Pharmacists. A lifelong advocate for the profession of pharmacy, Mr. Eckel has lectured on pharmacy issues and trends in all 50 states and has traveled to 6 continents to promote and educate audiences on the role of the pharmacist.