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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 .
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.
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 ...
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.
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 ...
In February 2022, Viatris announced an agreement where it will contribute to Biocon Biologics its biosimilars portfolio and related commercial and operational capabilities in exchange for up to $3.335 billion, including a stake of at least 12.9% in Biocon Biologics. [11] The transaction was completed in November 2022. [12]
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.
Cetuximab, sold under the brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor medication used for the treatment of metastatic colorectal cancer and head and neck cancer. [2]
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