On February 3, 2020, the Food and Drug Administration (FDA) and
the Federal Trade Commission (FTC) issued a joint statement
announcing their plans to collaborate in promoting competitive
biological product markets and addressing false or misleading
statements by manufacturers. According to the statement, the
coordination is intended to accelerate biosimilar competition by
reducing "gaming" of FDA requirements and other attempts
to unfairly delay competition. This dual-agency focus threatens
increased antitrust scrutiny for biologics manufacturers.
Biologics is currently the fastest growing segment of
prescription medicine spending. According to FDA, U.S. insurers
spent $125.5 billion on biologics in 2018 alone, accounting for 37%
of prescription drug spend. In 2010, Congress enacted the Biologics
Price Competition and Innovation Act, which created a shortened
pathway for FDA approval of biological products that are biosimilar
to an FDA-licensed reference product. To
