Biosimilars: Addressing Uncertainties With a New Drug Class

Kenneth G. Saag, MD, MSc

Jane Knight Lowe Professor
Division of Clinical Immunology and Rheumatology
Vice Chair, Department of Medicine
Center for Education and Research on Therapeutics
Center for Outcomes, Effectiveness Research and Education
Center of Research Translation in Gout and Hyperuricemia
University of Alabama at Birmingham
Birmingham, Alabama

Kenneth G. Saag, MD, MSc, has disclosed that he has received consulting fees from Abbott, Amgen, Ardea Biosciences/AstraZeneca, Bayer, Bristol-Myers Squibb, Merck, and Roche/Genentech.

View ClinicalThoughts from this Author

Released: March 13, 2017

Biosimilars: Addressing Uncertainties With a New Drug Class

In medicine, having choices is ideal. Both patients and providers appreciate options when discussing disease management. The beauty of biosimilars is that they afford choices for patients with diseases that have been, thus far, treated with very expensive biologics. However, as with any relatively new category of drug, biosimilars do face some uncertainty.

Long-term Safety
As I see it, the controversy with biosimilars is 2-fold. First, it remains to be seen if the requirements for the approval of biosimilars are sufficient to ensure their long-term safety. In most cases, the reference biologics have been available long enough that we have become comfortable and confident with their long-term safety. It is unknown whether we will discover unexpected safety issues with some biosimilars that do not exist with their reference drugs. We will have to wait for long-term, real-world data for reassurance. In the meantime, the issue of long-term safety has little practical impact on treatment decisions if the cost of a biosimilar is dramatically lower than the existing biologic. When given a choice, most patients who require these drugs will choose the more affordable copay.

That brings me to the second uncertainty surrounding biosimilars: substitution. If biosimilars are available at a lower price than the reference biologic, will third-party payers require patients to switch without a physician’s approval? Practicing clinicians have questions and concerns about this issue, and organizations such as the American College of Rheumatology are currently in discussions to formulate a policy addressing these concerns. My concern is that enforced substitution will rob the doctor–patient dyad of choice.

With a handful of biosimilars currently available and many more in the pipeline, questions about these issues are likely to arise more frequently between patients and providers. Yet by and large, the increasing availability of biosimilars has the potential for a positive societal impact by driving down prices in an arena that has seen substantial cost increases in the past decade.

Your Thoughts?
I’d like to hear from you. What challenges do you see arising as biosimilars become more widely available? How do you anticipate addressing these issues? I encourage readers to post their thoughts in the comments box below. Then, see the associated frequently asked questions module that addresses some of the most common questions regarding biosimilars. Do you have a question you want addressed? Submit your question here and we will try to address it in the next edition of frequently asked questions about biosimilars.

Jointly provided by Postgraduate Institute for Medicine and Clinical Care Options, LLC.
PIM Logo

Contact Clinical Care Options

For customer support please email:

Mailing Address
Clinical Care Options, LLC
12001 Sunrise Valley Drive
Suite 300
Reston, VA 20191

Supported by an educational grant from
Pfizer, Inc.

Leaving the CCO site

You are now leaving the CCO site. The new destination site may have different terms of use and privacy policy.


Cookie Settings