FDA Law Blog: Biosimilars
MARCH 18, 2025
Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015. With this long regulatory review period, the PTO granted the statutory-maximum five-year patent term extension. The plain text of 35 U.S.C.
European Pharmaceutical Review
DECEMBER 19, 2022
A biosimilar is a biological medicine ‘similar’ to another biological medicine already approved in the EU (the ‘reference medicine’). 1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product.
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Safe Biologics
OCTOBER 10, 2023
As we intended, this approach has been incredibly successful in controlling costs: the Congressional Budget Office projected drug spending between 2004-2013 to be $770 billion; actual expenses were 45% lower- at $421 billion. director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.
Safe Biologics
SEPTEMBER 11, 2023
As we intended, this approach has been incredibly successful in controlling costs: the Congressional Budget Office projected drug spending between 2004-2013 to be $770 billion; actual expenses were 45% lower- at $421 billion.
European Pharmaceutical Review
JULY 4, 2024
4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. 13 Currently, over 350 herbal remedies have been granted a THR licence. 2012/1916).
FDA Law Blog: Biosimilars
JUNE 13, 2024
Citing to a 2004 Supreme Court case, Verizon Commc’ns., 398 (2004), Teva argued that Amneal has no cause of action under antitrust law because the Hatch-Waxman Amendments impose a new statutory duty on a company to cooperate with competitors and established a remedy for breach of that obligation. of Trinko, LLP , 540 U.S.
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). By contrast, orphan drugs could become less profitable, more risky investments.
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