Study: Biosimilars as safe as branded drugs

In great news for biosimilar drug manufacturers, prescribers, pharmacists and patients, a new study found that biosimilar medications for arthritis and other diseases were as safe and effective as their brand-name counterparts.

“The billion-dollar question has been whether these ‘generic biologics’ are the same as the brand-name versions,” said G. Caleb Alexander, MD, an associate professor in the Department of Epidemiology at the Bloomberg School and co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, as well as co-leader of the study published in the August 2 issue of the Annals of Internal Medicine.

 “The same debate occurred with the advent of less-complicated generic drugs, and now it’s being hashed out all over again with much more at stake – more room for error and more potential for cost savings to the health system. But, based on the available evidence, we conclude that the products we studied appear comparable, and they will definitely be cheaper,” Alexander said.

However, many physicians are concerned about prescribing biosimilars because the FDA has said that biosimilars are “highly similar” to their reference products – not completely interchangeable with branded drugs like generics.

“Since a biosimilar drug is not identical to the reference innovator product, the efficacy and safety data generated for the latter cannot be directly and completely transferred to the biosimilar. Both its efficacy in various therapeutic indications and its safety profile in diverse risk populations may be different from that of the innovator,” said Dr. Suhasini Sharma, director of medical affairs for Sciformix Corporation in the company’s white paper, “Pharmacovigilance and Risk Management for Biosimilars: Unique Challenges and Possible Solutions”.

However, physicians are optimistic that they can use biosimilars interchangeably, since doing so could save patients and the healthcare industry a signficiant amount of money. Wide adoption of biosimilars could eventually save the health system billions of dollars, according to Johns Hopkins’ Bloomberg School.

Johns Hopkins researchers analyzed the scientific literature to compare original and biosimilar forms of tumor necrosis factor-alpha (TNF-α) inhibitors (the biosimilar Inflectra, Pfizer, and branded Remicade, Janssen Biotech) for rheumatoid arthritis, inflammatory bowel disease, and psoriasis. Other branded TNF-α inhibitors on the market include Humira, Cimzia, Enbrel, and Simponi, while many biosimilar versions of these products have been approved in Canada, Asia, and Europe.

The researchers analyzed data from 19 studies conducted through April, 2016, and found that, while there weren’t a large number of studies, biosimilar drugs have very similar safety and effectiveness as their branded counterparts.

“Our study should reassure clinicians and patients and, importantly, the folks who pay the bills – insurance companies and government programs like Medicare ­– that biosimilar TNF-α inhibitors appear comparable to their branded counterparts, based on the evidence we have thus far,” Alexander said. “Hopefully, this will encourage the brisk adoption of these products. There is no question that greater competition in this market will benefit patients, prescribers, and society in the long run.”

While this study only applies to TNF-α inhibitors, Alexander says it is an important and rigorous first look at a question that has been on the minds of many who worry about the future of a generic-type market for biologic drugs.

However, Alexander said that more systematic research is needed on whether other biosimilar products, such as biosimilar insulins, work as well as their branded counterparts.

And healthcare experts said the U.S. needs to examine Europe’s safety and efficacy data on biosimilar drugs, as it becomes available. “The European experience with biosimilars is going to be relevant. The biosimilar for infliximab, for example, is well-established for well over a year in some of the European markets,” said Murray Aitken, IMS Health senior vice president and executive director of the IMS Institute for Healthcare Informatics.

Plus, data being gathered now by European agencies will be relevant to help build confidence by the FDA, physicians and patients “around the safety and quality of the biosimilar drugs that are available,” Aitken said. “We should be looking at the European experience, so we can benefit from observing their experience.”