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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).

Tertiary Care

The level of care, usually on referral from primary or secondary medical care personnel, performed by specialists that consist of complex procedures and advanced technology,…