1 May 2017 - Biologic agents have an increasingly important role in clinical care, accounting for 22% of new US FDA drug approvals from 2010-2015 and comprising 28% of overall prescription drug revenue in 2015.

Biologics are generally made from living organisms and are larger, more complex molecules than conventional small-molecule drugs. Commonly used biologics include adalimumab (Humira), etanercept (Enbrel), and infliximab (Remicade), protein-based drugs used to treat rheumatologic diseases. With the goal of facilitating competition and generating cost savings for consumers, the Biologics Price Competition and Innovation Act, part of the Affordable Care Act, authorised an approval pathway for “biosimilars.” 

These are therapies with an active ingredient considered by the FDA to be highly similar to a reference biologic, such that there are no clinically meaningful differences in terms of safety, purity, and potency. Biosimilars can only be marketed after the reference biologic loses patent exclusivity.

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