A medicine derived from living cells cultured in a laboratory.

Biologics Price Competition and Innovation Act

The Affordable Care Act amends the Public Health Service Act to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the...


A drug with a similar composition to its biologic “reference” drug that has no differences in safety, potency, or purity.


Automated monitoring of health data sources to identify trends that may indicate an emerging epidemic, whether naturally occurring or as a result of bioterrorism.