Biologics Price Competition and Innovation Act of 2009 information
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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. The BPCI Act is closely related to the Drug Price Competition and Patent Term Restoration Act of 1984 (or referred to as the "Hatch-Waxman Act"), which established abbreviated pathways for the approval of drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).[1][2]
^Research, Center for Drug Evaluation and (16 September 2022). "Information on Biosimilars". www.fda.gov.
^"Archived copy" (PDF). Food and Drug Administration. Archived from the original (PDF) on 2015-11-29. Retrieved 2016-05-13.{{cite web}}: CS1 maint: archived copy as title (link)
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passed under the BiologicsPriceCompetitionandInnovationActof2009 (BPCI Act), which was passed as part of the Affordable Healthcare Act. But Zarxio was...
manufacture of generic biologics. However, the European Union and the United States (BiologicsPriceCompetitionandInnovationActof2009) do have in place...
approval of the U.S. Food and Drug Administration (FDA) as a biosimilar. This was the first product to be passed under the BiologicsPriceCompetitionand Innovation...
the Drug PriceCompetitionand Patent Term Restoration Act, informally known as the Hatch–Waxman Act, standardized procedures for recognition of generic...
Opinions of the Court". Supreme Court of the United States. Retrieved July 16, 2017. "2016 Term Opinions Relating to Orders". Supreme Court of the United...
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and gene therapy products. New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar...
on 'biologics'", USA Today, August 12, 2009, retrieved October 31, 2015 "Follow-on Biologic Drug Competition", Federal Trade Commission, June 2009, retrieved...
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pertinent to public safety during the Progressive Era. The 1902 Biologics Control Act was put in place after diphtheria antitoxin was collected from a...
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(including the Infrastructure Investment and Jobs Act). The Energy Innovation group estimated the reduction of greenhouse gas emissions at 37–41% below...
retail priceof electricity in Germany, among the highest in the world, stood at around 35 ¢/kWh. The EEG was preceded by the Electricity Feed-in Act (1991)...
quality of life, economic competitiveness, innovation, education and gender equality. It is one of the world's most ethnically diverse and multicultural...
The Biologics Control Actof 1902 required that federal government grant premarket approval for every biological drug and for the process and facility...
Zealand Ministry of Business, Innovationand Employment. Archived from the original on 27 May 2020. Retrieved 14 April 2020. "Research and development (R&D)...
2024-02-27. "Abbvie and Tentarix Announce Collaboration to Develop Conditionally-Active, Multi-Specific Biologics for Oncology and Immunology". MarketScreener...
services, bought the Bothell-based biologics facility from Lilly and retained the existing 127 employees. In January 2009, the largest criminal fine in U...
researchers. In addition, 58 National Medal of Science recipients, 29 National Medals of Technology andInnovation recipients, 50 MacArthur Fellows, 83 Marshall...
technological innovation, gives consumers a "fair share" of the benefit and does not include unreasonable restraints that risk eliminating competition anywhere...
than the cost of new drugs, because of a lack of awareness that the prices would have decreased due to generic competition. The process of evergreening...
Status of Supplemental Biologics License Applications (sBLA) for GARDASIL®". www.worldpharmanews.com. Archived from the original on 13 November 2009. Retrieved...
Determination of Action Pursuant to Section 301: China's Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, andInnovation" (PDF)...
development and evaluation of new and repurposed drugs andbiologics to treat patients for COVID-19, and, as of February 2021, Gates expressed that he and Anthony...
or biological farming, is an agricultural system that uses fertilizers of organic origin such as compost manure, green manure, and bone meal and places...
Single European Act. The Commission headed by Jacques Delors was seen as giving the Community a sense of direction and dynamism. Delors and his College are...
Pharmaceutical Innovationand Intellectual Property Law". U. Pitt. L. Rev. 67: 67. doi:10.5195/lawreview.2005.70. Joel, D (2009). "Pools, thickets and Open Source...
with first-class standing for Doctor of Medicine and Master of Surgery. In 1897, the University of Manitoba Act was amended in order to allow the Manitoba...
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