The American College of Rheumatology has published a new white paper, “The Science Behind Biosimilars — Entering a New Era of Biologic Therapy,” which shares the organization’s stance that it is reasonable for physicians to begin integrating the prescription of biosimilars as another option of medication in patient treatment, where appropriate.
S. Louis Bridges Jr., M.D., Ph.D., Anna Lois Waters Endowed Chair and director of the University of Alabama at Birmingham’s Division of Clinical Immunology and Rheumatology, served as the lead author on the paper. This white paper was intended to educate rheumatologists and other providers on the scientific, clinical, economic and prescribing issues related to the use of biosimilars.
A biosimilar is a form of medication that is highly similar to an approved biologic product. Because these agents are produced in living cells, biosimilars are not identical to the reference product. However, FDA-approved biosimilars have no clinically meaningful differences in safety or effectiveness as compared to the reference product; the attractiveness of biosimilar medications lies in their affordability relative to the reference product.
“Biosimilar integration into prescription patterns provides more options for patients — hopefully at a lower cost — and improves access to more patients who could benefit,” Bridges said. “Faculty members in our division are leading national discussions on biosimilars in the treatment of rheumatic diseases, and we’re proud to be a part of this.”
While biosimilar medications are newer to the American marketplace, they have been successful in their usage in other countries for many years. Currently, the FDA has approved nine biosimilar medications, six of which are used to treat rheumatic diseases.
With research that has been evaluated by regulatory agencies and professional organizations on biosimilar medication benefits, including efficacy, safety and cost, the American College of Rheumatology’s stance is one leaders hope will help validate the future of biosimilars as responsible forms of medication, potentially influencing their development and use in other fields.