Consensus Recommendations Issued for Biosimilars in Rheumatologic Diseases
An international expert group has issued consensus-based recommendations on the use of biosimilars for rheumatologic diseases, focusing on cost, extrapolation, and switching between bio-originators and biosimilars (published online September 2, 2017; doi:10.1136/annrheumdis-2017-211937).
The development of biosimilars offer expanded access to effective medications for patients with inflammatory diseases. However, the high cost of these medications has resulted in limited access for many patients, and there is uncertainty regarding the safety and efficacy of these agents among providers and patients.
In order to address these uncertainties, a group of international rheumatologists and other specialists—along with patient representatives—convened to perform a systematic literature review with the goal of providing up-to-date, evidence-based guidance. The panel used evidence obtained from these studies to develop a set of overarching principles and consensus recommendations.
Results of the review included five overarching principles and eight consensus recommendations, encompassing considerations regarding clinical trials, immunogenicity, extrapolation of indications, switching between bio-originators and biosimilars, and cost.
Initial statements include the following:
- Treatment of rheumatologic disease is a shared decision-making process between patients and their clinicians, and should be made in the context of the specific health care system.
- Patients must be informed of what biosimilars are, how they are approved, and what is known about their safety and efficacy.
- Once biosimilars are approved, they should be considered neither inferior nor superior to their bio-originators.
Among the notable consensus recommendations were:
- Availability of biosimilars must result in significant cost-lowering and increased access for individual patients.
- In the event of extrapolation, the biosimilar should be considered safe and effective for the bio-originator’s other approved indications.
In a position paper published on biosimilars by the American College of Rheumatology (ACR), authors state that "extrapolation should be pursued with caution," and that "if extrapolation is allowed by the FDA, then regulatory agencies and manufacturers should identify a minimum slate of disease states in which biosimilars should be tested before extrapolation to additional indications is granted."
Responding to this statement, Angus Worthing, MD, chair of the ACR government affairs committee, commented that “I think this is happening appropriately. What we're seeing is the vast majority of biosimilars being approved for each indication of the originator biologic in the US after careful analytical and clinical data review," (September 8, 2017).—Zachary Bessette