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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).

Qualifying Therapeutic Discovery Project

Tax credits offered to small businesses investing in new treatment research. Qualifying businesses must have less than 250 employees, and tax credit can be applied…