Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars

Area of Science:

• Pharmacoeconomics and Health Outcomes Research
• Biopharmaceutical Policy and Regulation
• Real-World Evidence Generation

Background:

• Increasing availability of biosimilars in the US necessitates robust postapproval studies.
• Noninterventional studies are crucial for generating real-world evidence on biosimilar switching.
• Sound methodology is essential for valid inferences in biosimilar comparative effectiveness and safety studies.

Framework:

• Recommendations cover data sources (claims, EHRs, registries), study designs, and outcomes (utilization, clinical endpoints).
• Guidance includes analytic approaches (propensity scores, instrumental variables) and special considerations.
• Focus on reference biologic to biosimilar switching, including initiation and follow-up.

Implementation:

• A workgroup of academic, industry, and clinical experts developed consensus-based recommendations.
• Eight teleconferences were held between August 2017 and February 2018.
• The framework addresses five key considerations for study design and evaluation.

Implications:

• Provides a framework for designing and evaluating postapproval noninterventional studies on biosimilar switching.
• Aims to inform clinical practices and policy decisions by ensuring methodologically sound real-world evidence.
• Facilitates critical appraisal of studies comparing biosimilars and reference biologics.