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  2. Biosimilar - Wikipedia

    en.wikipedia.org/wiki/Biosimilar

    The first biosimilar of a monoclonal antibody to be approved worldwide was a biosimilar of infliximab in the EU in 2013. [9] On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz .

  3. 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.

  4. Drug Price Competition and Patent Term Restoration Act

    en.wikipedia.org/wiki/Drug_Price_Competition_and...

    The FDA has been slow to adopt regulations for the introduction of generic versions of biopharmaceutical drugs (known as "biosimilars") because proving biosimilarity and quality control for biopharmaceuticals is much more complicated than for small molecule drugs. Innovator companies have emphasized those complications while generic companies ...

  5. List of therapeutic monoclonal antibodies - Wikipedia

    en.wikipedia.org/wiki/List_of_therapeutic...

    Therapeutic, diagnostic and preventive monoclonal antibodies are clones of a single parent cell. When used as drugs, the International Nonproprietary Names (INNs) end in -mab.

  6. 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 ...

  7. Adalimumab - Wikipedia

    en.wikipedia.org/wiki/Adalimumab

    In 2018, the biosimilars Halimatoz, [18] Hefiya, [19] Hyrimoz, [22] and Hulio [21] were approved for use in the European Union. Adalimumab biosimilars became available in the European Union in 2018, [ 112 ] allowing the National Health Service to make record-breaking cost-savings, [ 113 ] as this is the single most expensive drug used in NHS ...

  8. Association for Accessible Medicines - Wikipedia

    en.wikipedia.org/wiki/Association_for_Accessible...

    As the primary lobby for makers of generic drugs, [1] AAM's stated mission is to advocate for public policies that facilitate timely access to lower-cost, FDA-approved generic and biosimilar medicines by consumers and patients. Over the 10-year period 2008 through 2018, the use of generic drugs generated $2 trillion in U.S. healthcare savings.

  9. Eculizumab - Wikipedia

    en.wikipedia.org/wiki/Eculizumab

    Bekemv is a biosimilar medicinal product. [50] It is highly similar to the reference product Soliris (eculizumab), which was authorized in the EU on 20 June 2007. [50] Data show that Bekemv has comparable quality, safety and efficacy to Soliris. [50] Bekemv was approved for medical use in the European Union in April 2023. [51] [1]