Products that are “biosimilar” or interchangeable with a licensed biological product hold considerable promise for the treatment of a variety of medical conditions such as rheumatic diseases, and possibly at a reduced cost. In Arthritis & Rheumatology, the American College of Rheumatology (ACR) has published its latest position statement (or Whitepaper) on the rationale for the use of biosimilars in clinical practice.
While the initial position of the ACR on biosimilars urged caution as the products were being developed, evaluated, and approved, this latest Whitepaper notes that healthcare providers should now incorporate biosimilars, where appropriate, into their regimens to treat patients with rheumatic diseases. “Now that biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use, and as the US is on the verge of a similar transition, the ACR is poised to reconsider its position,” the authors wrote.
The paper also stresses that communication between providers, pharmacists, and patients will be critical to alleviate anxiety and reduce skepticism regarding the use of newly available agents. “We remain optimistic that the use of biosimilars will improve patient access to biologic agents, allowing continued delivery of high quality healthcare to be realized at a lower cost to the individual patient,” the authors wrote.
An accompanying editorial by Dr. Roy Fleischmann, of the University of Texas Southwestern Medical Center and Metroplex Clinical Research Center in Dallas notes that there are many clear statements (white), but there are also arguments that are open to alternative opinions (gray) and arguments that are open to an alternative conclusion (black). “It is not at all clear that a biosimilar will be cheaper to the patient – it may be cheaper to the pharmacy benefit management firm, but this may not really help patient access to these medications. It is also not clear that non-medical substitution will be effective in every patient nor has it been demonstrated that extrapolation is effective, said Dr. Fleischmann. “These are the major questions remaining unanswered with respect to the use of biosimilars in rheumatic disease.”
Study examines safety and effectiveness of infliximab biosimilar in patients with inflammatory bowel disease
Roy Fleischmann, The American College of Rheumatology White Paper on Biosimilars – It isn’t all White – there is some gray and black, Arthritis & Rheumatology (2018). DOI: 10.1002/art.40402