Protecting Access to Biosimilars Act of 2019

Summary

Protecting Access to Biosimilars Act of 2019 This bill excludes biological products that were initially licensed under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (e.g., insulin) from the exclusivity protections that delay the licensure of biosimilar products under the Public Health Service Act (PHS Act). (The Biologics Price Competition and Innovation Act of 2009 generally requires that biological products approved under the FD&C Act are treated as though they were approved under the PHS Act through March 23, 2020.)

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Timeline

1. 11 April 2019

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 11 April 2019

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 11 April 2019 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 11 April 2019

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 11 April 2019

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 11 April 2019

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Smith, Tina [D-MN] · D · Sponsor
• Sen. Cassidy, Bill [R-LA] · R · Sponsor
• Sen. Cramer, Kevin [R-ND] · R · Cosponsor
• · sshr00 · Standing

Related records

• related to → Protecting Access to Biosimilars Act of 2019
• related to ← Lower Health Care Costs Act