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  2. Biosimilar - Wikipedia

    en.wikipedia.org/wiki/Biosimilar

    In 2018, the FDA released a Biosimilars Action Plan to implement regulations from the BPCI, including limiting the abuse of the Risk Evaluation and Mitigation Strategy (REMS) system for evergreening and transitioning insulin and human growth hormone to regulation as biologics rather than drugs. [136]

  3. Food and Drug Administration Safety and Innovation Act

    en.wikipedia.org/wiki/Food_and_Drug...

    The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.

  4. Biologics Price Competition and Innovation Act of 2009

    en.wikipedia.org/wiki/Biologics_Price...

    The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product.

  5. Biopharmaceutical - Wikipedia

    en.wikipedia.org/wiki/Biopharmaceutical

    With the expiration of many patents for blockbuster biologics between 2012 and 2019, the interest in biosimilar production, i.e., follow-on biologics, has increased. [17] Compared to small molecules that consist of chemically identical active ingredients, biologics are vastly more complex and consist of a multitude of subspecies. Due to their ...

  6. List of largest pharmaceutical settlements - Wikipedia

    en.wikipedia.org/wiki/List_of_largest...

    The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2013, ordered by the size of the total settlement.

  7. Teva Pharmaceutical Industries (TEVA) Q4 2024 Earnings Call ...

    www.aol.com/teva-pharmaceutical-industries-teva...

    Image source: The Motley Fool. Teva Pharmaceutical Industries (NYSE: TEVA) Q4 2024 Earnings Call Jan 29, 2025, 8:00 a.m. ET. Contents: Prepared Remarks. Questions and Answers. Call Participants

  8. CVS Health (CVS) Q3 2024 Earnings Call Transcript - AOL

    www.aol.com/cvs-health-cvs-q3-2024-173019204.html

    Image source: The Motley Fool. CVS Health (NYSE: CVS) Q3 2024 Earnings Call Nov 06, 2024, 8:00 a.m. ET. Contents: Prepared Remarks. Questions and Answers. Call ...

  9. Viatris - Wikipedia

    en.wikipedia.org/wiki/Viatris

    Following the formation of Viatris, the company became a member of the Biosimilars Forum, a trade organization that advocates for greater biosimilar usage. [ 32 ] Viatris partnered with the American College of Cardiology , the NCD Alliance , and the World Heart Federation to create the NCD Academy, a platform to help fight non-communicable ...

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