Using medicare administrative data to conduct postmarketing surveillance of follow-on biologics: Issues and opportunities

By 2010, it is estimated that $10 billion in biologics will have lost patent protection and that generic versions, or "follow-on" biologics, will begin to emerge. The manufacturing processes required to produce biologics are complex, and safety and efficacy profiles may be specific to the manufacturer. Postmarketing surveillance studies may be required to detect rare safety signals. Medicare claims may provide a useful mechanism for postmarketing surveillance of follow-on biologics. The authors briefly describe the regulation of innovator and follow-on biologics, the need for postmarketing surveillance of follow-on biologics, and how Medicare claims data might be used to monitor postapproval safety.