The House bill would amend the Public Health Service Act (“PHS Act”) and is intended to address so-called “pay-for-delay” agreements, according to Representative John Sarbanes (D-MD), one of the authors of the bill. PHS Act § 351(l) would be amended by adding item “(10)”, which would require the reporting of any agreement between a biosimilar applicant and a reference product sponsor, or an agreement between two or more biosimilar applicants, regarding the manufacture, marketing, or sale of the biosimilar product(s) for which a 351(k) a BLA was submitted to FDA, or the brand-name reference product. Not included are agreements related to purchase orders for raw material supplies, equipment and facility contracts, employment or consulting contracts and packaging and labeling contracts.
The Senate Bill would amend Sections 1111-1118 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”). Certain agreements between biosimilar applicants and reference product sponsors would be required to be reported to the FTC and DoJ. The reporting requirements would be similar to those that already exist for drug products regulated under the FDC Act.
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