Licensing new uses of existing medicines has several benefits over off-label use, such as offering assurances that the indication is evidence based and subject to an ongoing safety monitoring program, according to a new report.
The UK health authorities are to set up a new national drug repurposing scheme with the aim of supporting the licensing of two or three new indications of existing drugs each year, rising to six by year three of the project.
A draft route map has been developed and the scheme will be tested with initial pilot topics, “taking into account...
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A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
This article compiles all of the data from Generics Bulletin’s 2025 ranking of the Top 50 firms across the generics and biosimilars industry, including additional details of how the various financial figures stack up.
In the third instalment of this year’s Generics Bulletin Top 50, we reveal which firms have entered the ranking for the first time.
In the second instalment of Generics Bulletin’s Top 50 ranking for 2025, we see plenty of movement among our mid-table collection of companies.
As many as ten generic versions of Novartis’ blockbuster heart failure drug Entresto (sacubitril/valsartan) have begun entering the US market following recent key legal victories by MSN Laboratories.
US non-profit Civica has announced a partnership with Fresenius Kabi to supply a Stelara rival, revealing pricing details for its exclusive unbranded version of Kabi’s Otulfi biosimilar that will be available from the start of next year.
Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.
