Dibotermin Alfa (rhBMP-2): A Comprehensive Analysis of an Osteoinductive Biologic

I. Executive Summary

Dibotermin alfa, a recombinant form of human Bone Morphogenetic Protein-2 (rhBMP-2), represents a seminal achievement in the field of regenerative medicine and biotechnology. As a potent osteoinductive agent, it is engineered to stimulate the body's natural bone-forming pathways, offering a powerful therapeutic tool for complex orthopaedic and dental challenges. Its clinical utility has been firmly established in specific, well-defined indications: as a substitute for autogenous bone graft in single-level lumbar spinal fusion and as an adjunct to standard care for the treatment of severe, acute open tibial shaft fractures. In these contexts, Dibotermin alfa has demonstrated significant benefits, including the elimination of donor site morbidity associated with bone harvesting and a reduction in the need for secondary surgical interventions in trauma patients.

However, the clinical and commercial history of Dibotermin alfa is a profound and cautionary narrative, defined by a stark contrast between its proven efficacy and a legacy of significant safety issues and ethical controversies. Marketed as InFUSE™ Bone Graft in the United States and InductOs in Europe, the product's trajectory has been marked by widespread off-label use, particularly in the cervical spine, which led to reports of severe, life-threatening complications not observed in its approved applications. This practice, allegedly fueled by aggressive and illegal manufacturer promotion, prompted a stern public health warning from the U.S. Food and Drug Administration (FDA) and triggered extensive governmental and legal investigations.