2007 Biosimilars Documentation 
Putting Patients First Blog
JUNE 26, 2025
CMS should draw on lessons from previous transitions, including biosimilar coverage rollouts and site-of-care policy shifts, to avoid known implementation pitfalls. https ://www.medpac.gov/document/june-2024-report-to-the- congress-medicare-and-the-health-care-delivery-system/. Joseph Mattingly II, Anthony A. 7 Gabriella M.
Pharmacy Times
JULY 29, 2025
Geison’s findings, which draw on Pasteur’s previously inaccessible laboratory notebooks, offer detailed documentation of how public scientific claims may be shaped by selective presentation of data. Specifically, psychology and psychiatry were among the disciplines where this increase was observed to be highest (P < 001).
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European Pharmaceutical Review
DECEMBER 20, 2023
Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). What are the latest amendments?
Pharmaceutical Technology
FEBRUARY 24, 2023
But the EU draft document says that the changes will make medicines more affordable, improve unequal access to medicines across the EU, and fulfil unmet patient needs. He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.
FDA Law Blog: Biosimilars
JULY 15, 2025
This definition is familiar to drug manufacturers because it is substantially identical to the definition that has existed under the MDRP since 2007. The manufacturer’s documentation of the methodology used to determine fair market value would have to be submitted, along with other reasonable assumptions, to CMS each quarter.
FDA Law Blog: Biosimilars
MAY 11, 2023
No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.” Plainly, the Government brief states “The decision below is incorrect. GSK filed a supplemental brief in response to the Government’s brief.
FDA Law Blog: Biosimilars
MAY 26, 2025
The gray box at the top of the document at this link shows the change in position. 118, 129 (2007) (quoting Abbott Labs v. One notable exception has been the Administrations targeting of certain surgical procedures and the use of certain drugs for a particular intended purpose. MedImmune, Inc. Genentech, Inc., Gardner , 387 U.S.
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