Navigating the Biosimilars from Bench to Bedside in Juvenile Idiopathic Arthritis.

Abstract

Biosimilar use for pediatric rheumatologic conditions, such as juvenile idiopathic arthritis (JIA), is increasing owing to the development and release of multiple biosimilars into the US market. The US biosimilar development process of bio-originator and generic medications differs. Bio-originators typically spend the longest amount of time in research and development and require the largest financial investment, followed by biosimilars and, lastly, generic medications. Data available from European countries, where biosimilars have been made available much earlier than in the USA, support the effectiveness and safety of biosimilars in patients with JIA. However, European rheumatology clinicians surveyed highlight continued concerns regarding biosimilar data and experience. Although there are varying perspectives of major stakeholders on biosimilars in the USA-the patients and caregivers, clinicians, manufacturers, and pharmacy benefit managers (PBMs)-the primary goal of all should be patient benefits. These benefits may include improved medication healthcare access overall and during shortage situations or promoting the innovation of biobetters, but biosimilars may conversely negatively impact provider reimbursement, or manufacturers may drive out competition of competing biosimilar manufacturers. There are risks associated with lack of education for medical staff and patients, such as the nocebo effect, and how to reduce those risks is through assisting patients in understanding their new medication and reasons for the change. Credible biosimilar resources may be used to educate medical staff and patients, including the Food and Drug Administration (FDA), American College of Rheumatology (ACR), and Arthritis Foundation. After a patient has been transitioned to a biosimilar, it is necessary to have appropriate medical follow-up and continuous monitoring for efficacy and safety.