What do patients know about generic biotech drugs?

pills in hand (iStock)

Many patients haven’t heard of “biosimilars,” generic versions of complex biotech drugs, and even some who say they’re familiar with these medicines may still be confused about them, a small European survey suggests.

Biotech drugs known as biologics are injected medicines, typically containing proteins like antibodies made from living cells, and often carry price tags north of $100,000 a year. Copies of these biotech drugs are called biosimilars because they can have the same ingredients and recipe without being exact copies of the original brand-name therapy.

To see what patients know about biosimilars, researchers analyzed data from online surveys completed by 1,181 patients with irritable bowel disease or Crohn’s disease, chronic intestinal problems that are increasingly treated with biosimilars.

Overall, just 38 percent of the survey respondents had heard of biosimilars.

When researchers asked these 383 people more questions to see what they knew about these medicines, 47 percent said they worried about whether the copies were safe and 40 percent said they had concerns about whether the generics were effective, researchers report in the Journal of Crohn’s and Colitis.

“I think it’s human nature to be suspicious of anything unfamiliar or something new that could replace a product (the innovator biologics) that you already are comfortable with,” said Donald Miller, a pharmacy researcher at North Dakota State University in Fargo who wasn’t involved in the study.

It’s also possible, though, that people who already have concerns about biosimilars may have been more likely than other individuals to complete the survey, Miller added by email.

“Should patients really be worried? No,” said Miller, who has served on expert panels advising U.S. drug regulators about biosimilars.

The study by Dr. Laurent Peyrin-Biroulet of Nancy University Hospital and the University of Lorraine in France also found most patients were more concerned about the safety and effectiveness of biosimilars than whether they were a lower-priced alternative to brand name biotech drugs.

Only about 25 percent of the participants who were familiar with biosimilars said they didn’t have any concerns about these medicines, the study found.

Before biosimilars reach the market, they go through rigorous clinical tests to ensure that they’re safe and effective, noted Dr. Daniel Solomon, a researcher at Brigham and Women’s Hospital and Harvard Medical School in Boston who wasn’t involved in the study.

“They are almost identical from the standpoint of their chemical structure and pharmacologic properties,” Solomon, who wasn’t involved in the study, said by email.

“Differences must be proven to not affect the safety or benefits of the drug,” Solomon added. “While they are not identical to the original drug, they are extremely similar and have been put through very rigorous testing.”

The study was funded by a drug industry grant and the authors have numerous financial ties to companies that make brand name biotech drugs. Dr. Peyrin-Biroulet didn’t respond to emails seeking comments on the study.

It’s also likely that the results may be biased because, like many online surveys, it’s an unknown population, noted Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore.

Even so, the findings highlight the need for more patient education about biosimilars, Alexander, who wasn’t involved in the study, said by email.

“Some patients may rightly have questions and concerns about biosimilar products – this is understandable and it is important that clinicians and health systems and other stakeholders work to address these questions and ensure that any misconceptions about these products are addressed,” Alexander said.