Generic forms of biologic drugs can be just as safe, effective as name brand counterparts

The question of whether generic forms of biologics—the notoriously hard to manufacture drugs made from living cells—can be just as effective as established brand names is a billion-dollar question for the healthcare industry. A new Johns Hopkins study suggests that yes, they can.

Researchers from the Johns Hopkins Bloomberg School of Public Health found that generic forms of biologic drugs used to treat rheumatoid arthritis, inflammatory bowel disease, and psoriasis appear to be just as safe and effective as their brand-name counterparts. The findings will be published Tuesday in The Annals of Internal Medicine.

"Based on the available evidence, we conclude that the products we studied appear comparable, and they will definitely be cheaper," says study leader G. Caleb Alexander, associate professor in the Department of Epidemiology at the Bloomberg School and co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. "There is no question that greater competition in this market will benefit patients, prescribers, and society in the long run."

Biologics represent the fastest growing sector of pharmaceuticals, with their sales expected to make up 20 percent of the market by 2017. Though generic forms of the drugs, known as biosimilars, have the potential to save the healthcare system billions of dollars, companies have cautioned that these drugs shouldn't be considered interchangeable with established biologics that have been on the market for years.

The pharmacologic activity of biologics depends heavily on their manufacturing, wherein small variations can alter the structure of the end product. Due to this variability—and the large, complex nature of biologics—it's impossible to create an exact replica of a biologic. The stakes on this issue are rising now, as many biologics are coming off patents that have guaranteed their exclusivity.

For their study, the Hopkins researchers compared original and biosimilar forms of tumor necrosis factor-alpha (TNF-α) inhibitors, a treatment for rheumatoid arthritis, inflammatory bowel disease, and psoriasis. This class of drugs suppresses activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases.

Looking at data from 19 past studies, the researchers concluded that biosimilars in this case show very similar safety and effectiveness to their brand-name counterparts.

Currently, only one TNF-α inhibitor biosimilar—Inflectra—has Food and Drug Administration approval in the United States, while many biosimilar versions have approval in Canada, Asia, and Europe. Inflectra is a biosimilar for a biologic drug sold under the brand name Remicade. Other branded TNF-α inhibitors on the market include Humira, Cimzia, Enbrel, and Simponi.

Because this study focuses only TNF-α inhibitors, Alexander notes that more systematic research is needed on other biosimilar products. Many new cancer drugs are also biologics, as is insulin.

"Biologics are the wave of the future," Alexander says. "That's where more and more of the pharmaceutical market is going in the years ahead."