Tweet This

Biosimilars User Fee Act

Creates an abbreviated licensure pathway for biologic products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biologic product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act).

Global Budgeting

A method of constraining costs wherein multiple providers are expected not to exceed a certain spending target (for example, the SGR), or where a provider…