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Evaluating Utilization, Safety Studies for Biologic, Biosimilar Surveillance

April 16, 2020

The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network (DRN) may be considered a potential resource for surveillance of biologics, according to a study published in the Journal of Managed Care & Specialty Pharmacy (April 2020;26[4]:417-490).

The patient population included in biosimilar pre-approval clinical trials may not be large or heterogeneous enough to identify and assess serious adverse events. Thus, it is important to generate post-marketing evidence for safety monitoring and evaluation of approved biologics and biosimilars.

The BBCIC is a multistakeholder, non-profit public service initiative that provides scientific evidence on the comparative safety and effectiveness of biosimilars and novel biologics. Through its DRN, the BBCIC is able to conduct claims-based research specific to biologics using the FDA Sentinel System common data model and analytic tools.

Kevin Haynes, PharmD, MSCE, HealthCore (Wilmington, DE), and colleagues sought to assess the feasibility, strengths, and limitations of the BBCIC DRN to examine the utilization and comparative safety of immune-modulating agents among patients with autoimmune diseases. The retrospective cohort study included adult patients who were new users of a disease-modifying non-biologic and/or biologic agent with a prior diagnosis of rheumatoid arthritis (RA; n = 111,611), other inflammatory conditions (eg, psoriasis, psoriatic arthritis, and ankylosing spondylitis; n = 61,050), or inflammatory bowel disease (IBD; n = 30,628) who were enrolled in health insurance plans participating in the BBCIC DRN between January 2006 and September 2015.

Patient follow-up started at treatment initiation and ended at the earliest record of serious infection, treatment discontinuation, switching, death, disenrollment, or end of study period.

Researchers found that across all three cohorts, close to half of the patient drug episodes initiated a biologic (50% in RA, 60% in other inflammatory conditions, and 55% in IBD). Crude incidence rate of serious infection was 9.8 cases per 100 person-years in the RA cohort, 7.1 cases per 100 person-years in the other inflammatory conditions cohort, and 14.2 cases per 100 person-years in the IBD cohort.

“This study successfully identified large numbers of new users of biologics and produced results that were consistent with those from earlier published studies,” authors of the study concluded, noting these results as support for the BBCIC DRN as a potential resource for surveillance of biologics.—Zachary Bessette

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