ACR: With Biosimilars, Patient Safety Must Come First

Cheaper therapies are not always the best thing for patients.

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In our pursuit of healthcare solutions that are as cost effective as they are successful, it's exciting when new therapies emerge that promise to ease both physical suffering and pain in the pocketbook.

But, as sometimes said in the development of other products on the market: do we want them fast, good, or cheap? It's impossible and unrealistic to have it all.

It's a conundrum that many patients, policymakers, and providers currently face as biosimilar therapies emerge as potential alternatives for biologics. Notoriously costly, biologics are medications produced from living cells that have proved remarkable in treating debilitating conditions like rheumatoid arthritis, ulcerative colitis, psoriasis, and even some cancers. Biosimilars are structurally similar to biologics and will be used to treat some of the same illnesses. Ultimately, the hope is that the introduction of biosimilars in the U.S. will drive down the cost of existing biologics and result in access to more affordable medications for millions of patients.

Recent FDA approval of the first-ever biosimilar drug for sale in the U.S., Zarxio (filigrastim-sndz), paved the way for other biosimilar alternatives to be introduced. Remicade (infliximab), a biosimilar designed to treat certain rheumatic diseases such as rheumatoid arthritis, Crohn's disease, and plaque psoriasis, is already being considered for FDA approval. As additional biosimilar alternatives are approved and begin to hit the marketplace, consumers will want access to proven therapies at a lower cost. Policymakers want to harness the promise of reducing healthcare expenditures. And, of course, everyone wanted it to happen yesterday.

It's an understandable position. Biologics are the most costly medications available, ranging in price from $1,000 to more than $50,000 per treatment. In some cases, biologics cost hundreds of thousands of dollars per year per patient. In Japan and throughout the European Union, biosimilars have been for available for years, and prices are 15% to 30 % lower than their brand-name counterparts.

Despite this promise of savings, what we cannot afford to overlook in our drive for more affordable care is that biosimilars, though "similar" as their name portends, are not mere copies of biologics and easily replicated.

Unlike generic medicines that have an identical chemical makeup to their brand-name counterparts and are inexpensively duplicated, biosimilars are complex substances created from living organisms. They are sensitive to minor changes in the manufacturing process and have the potential to be less effective or cause more side effects compared with the original biologic. Biosimilars may interact differently with a patient's immune system and increase the likelihood of harmful reactions.

Biosimilars are indeed exciting and promising for the future treatment of many devastating illnesses. But safely bringing them to market requires adequate study prior to FDA approval, careful dispensing to protect patient safety, and monitoring for potential harm in patients.

Healthcare providers and patient advocates are committed to ensuring speed doesn't supersede safety.

Perhaps the most important consideration for policymakers is the need for rigorous clinical trials to ensure the safety, efficacy, and interchangeability of biosimilar drugs with original biologic drugs. History has shown the need for careful study: in the late 1990s, there was a drastic increase in the number of European patients who suffered a life-threatening reaction after using a biosimilar of the more widely known biologic Epogen. Ultimately linked to a change in the manufacturing process, once identified and corrected, incidence of the life-threatening reaction dropped by 90%.

Even with robust clinical trials and other studies to ensure efficacy, once a biosimilar is approved and available for use, it's absolutely essential that safeguards are in place to ensure that patients' therapies are not indiscriminately switched because of cost, insurance considerations, or other factors. Only the patient's physician should be allowed to prescribe a biosimilar, and substitutions by pharmacists or anyone else could cause significant harm.

If the progress we have seen thus far with biologics and biosimilars is any indication, the future for patients is bright. Good therapies at better prices are sure to offer hope and peace of mind to millions. But no matter the temptation, we cannot afford to rush a process and fail to implement safeguards. The lives -- and health -- of Americans depend on it.

K. Kwas Huston, MD, is a member of the American College of Rheumatology Rheumatologic Care Committee, practicing rheumatologist at Kansas City Physician Partners, and Clinical Assistant Professor at the University of Missouri Kansas City School of Medicine.

The American College of Rheumatology is an international medical society representing over 9,400 rheumatologists and rheumatology health professionals with a mission to Advance Rheumatology. In doing so, the ACR offers education, research, advocacy, and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatologists are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases. For more information, visit


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