Preserve Access to Affordable Generics and Biosimilars Act

Summary

Preserve Access to Affordable Generics and Biosimilars Act This bill amends the Federal Trade Commission Act to authorize the Federal Trade Commission to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement, with specified exceptions, is presumed to have anticompetitive effects and violates this bill if the filer of an abbreviated new drug (generic) application or a biosimilar biological product application: (1) receives anything of value; and (2) agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar biological product for any period of time.

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Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 19 December 2018

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 19 December 2018

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• Introduced in Senate

  summary · EN · 19 December 2018

  Open at official source

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