Generic Drugs

  • Read more: The Rise of Biosimilars: Success of the BPCIA? (Part III)
    Article

    The Rise of Biosimilars: Success of the BPCIA? (Part III)

    By Jonathan Darrow This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part III considers a path forward in the regulation of biologics.  For Part I, click here.  For Part II click here….

    Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.
  • Read more: The Rise of Biosimilars: Success of the BPCIA? (Part II)
    Article

    The Rise of Biosimilars: Success of the BPCIA? (Part II)

    By Jonathan Darrow This is Part II in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part II covers some key considerations and factors that impact the biologics market and regulation.  For Part I, click here. Reference…

    Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.
  • Read more: The Rise of Biosimilars: Success of the BPCIA? (Part I)
    Article

    The Rise of Biosimilars: Success of the BPCIA? (Part I)

    By Jonathan Darrow This is Part I in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already-approved biological medicines.  This Part briefly covers the history of American regulation of biologics and touches briefly on the European experience. The Biologics Price Competition…

    Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.
  • Read more: Monthly Round-Up of What to Read on Pharma Law and Policy
    Article

    Monthly Round-Up of What to Read on Pharma Law and Policy

    By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division. Below are the abstracts/summaries…

    close up of an open book
  • Read more: Monthly Round-Up of What to Read on Pharma Law and Policy
    Article

    Monthly Round-Up of What to Read on Pharma Law and Policy

    By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division. Below are the abstracts/summaries…

    Stack of colorful books in front of a wood paneled wall
  • Read more: Legal Challenges to California’s Pay-for-Delay Ban
    Article

    Legal Challenges to California’s Pay-for-Delay Ban

    By Phebe Hong On October 7th, toward the end of his health care “bill-signing marathon,” Governor Gavin Newsom signed bill AB 824, making California the first state to ban pharmaceutical “pay-for-delay” deals. The new law prohibits pay-for-delay deals, which is the practice of pharmaceutical companies giving “anything of value” to generic manufacturers to keep lower-cost…

    Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging