Using real-world data to evaluate biosimilar switching

摘要

We read with interest the review by Desai et al on "Methodologic considerations for non-interventional studies of switching from reference biologic to biosimilars." Following the Biologics Price Competition and Innovation Act that created an abbreviated approval pathway in the United States for biosimilar and interchangeable biological products in 2010, biosimilars have been approved to treat a variety of conditions, including neutropenia, rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis, psoriasis, psoriatic arthritis, anemia, and various malignancies. Product-specific information, including a summary of the US Food and Drug Administration's (FDA) review of the data used to support approval, can be found at the Drugs@FDA website.