As Stelara biosimilars wait in the wings, proposed legislation in the US could ease the path to commercialization. The Draft Red Tape Elimination Act aims to remove a requirement for switching studies. Opposition to the bill is expected, but if passed how much will the Act move the biosimilars needle in the country? Scrip spoke to experts to gauge its likely impact.
About mid-July, Senator Mike Lee and a few other senators re-introduced draft legislation in the US that would stop the Food and Drug Administration (FDA) from requiring switching studies for biosimilars to obtain an interchangeability designation.
If the draft Red Tape Elimination Act is approved, it could help the cause of biosimilar penetration in the US, a market that has substantially lagged Europe in uptake
The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.
Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.
Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.
An ‘historic economic prosperity deal’ does not include the sector.
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In this week's episode: industry makes its case to Trump; Sarepta slammed by double blow; Chinese firms build obesity pipeline; Swiss biopharma staying strong; and Merck & Co looks to immunology and ophthalmology.
The Japanese drug maker is on track for three pivotal Phase III readouts and two regulatory submissions in 2025.
