Preserve Access to Affordable Generics and Biosimilars Act

Increased Competition and Lower Costs: By stopping agreements that delay the marketing of low-cost generic and biosimilar drugs, the bill intends to enhance competition in the pharmaceutical market (Section 2(b)(1)).

Improved Patient Access: Competition from biosimilar and interchangeable biological products is expected to increase patient access to biological medicines (Section 2(a)(9)).

Protection Against Unfair Business Practices: The bill treats certain settlement agreements as unfair methods of competition, providing a legal mechanism to prevent branded companies from sharing monopoly profits with competitors to protect their own monopolies (Section 3(a)(1) and Section 2(a)(6)(B)(i)).

Deterrence through Penalties: The bill establishes civil penalties of up to three times the value received to deter companies from entering into anticompetitive agreements (Section 3(a)(5)(A)).

Exceptions to the Prohibition: The law does not apply to certain settlements, such as those providing for reasonable litigation expenses up to a specific limit (Section 3(b)(2)), which may allow some types of payments to continue.

Burden of Proof for Exceptions: Parties can avoid the presumption of anticompetitive effects if they can demonstrate by a preponderance of the evidence that the value was for other goods or services, or that procompetitive benefits outweigh the anticompetitive effects (Section 3(a)(3)(B)).