Biosimilars To Be Subject To Same Pay-For-Delay Deal Reporting As Generics
Legislation headed to President Trump would also ban pharmacy "gag" clauses.
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US Congress wants to prohibit contracts that prevent pharmacists from alerting customers to opportunities to save money by paying out of pocket. Legislation is moving rapidly, but once again, a simple fix to a drug pricing issue may have unintended consequences.
If approved in the US, Samsung Bioepis' adalimumab biosimilar may launch June 30, 2023, five months after the market entry date for Amjevita under Amgen's agreement with AbbVie; the 150-day marketing advantage for the first biosimilar approved suggests a benchmark for future patent litigation settlements.
Federal Trade Commission and Department of Justice should be able to scrutinize settlements between biologic reference product sponsors and biosimilar developers, Express Scripts says; PBM's policy proposals for coming year include safe harbor for certain value-based reimbursement arrangements, and mandatory electronic prescribing and dispensing limits for opioids.