Barriers and facilitators to conduct high-quality, large-scale safety and comparative effectiveness research: The Biologics and Biosimilars Collective Intelligence Consortium experience

摘要

In 2010, the Biologics Price Competition and Innovation Act was enacted in the United States to balance biologic innovation with fostering competition by establishing an abbreviated regulatory approval pathway for biosimilar drugs. Approved biosimilars are highly similar with no clinical difference to an already Food and Drug Administration (FDA)-approved biologic drug (ie, "reference"). The complexity of manufacturing biologic products, coupled with lack of understanding about regulatory approval requirements for biosimilars, has led to lingering uncertainty among patients and healthcare providers regarding the comparative safety and effectiveness of these products.