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Action is needed from both the UK government and the European Commission to prevent a collapse of Northern Ireland’s generics market, according to the BGMA.
The FTC has won the backing of an appeals court over its 2019 decision that found a reverse-payment settlement deal between Impax and Endo over Opana ER to be anti-competitive and illegal.
Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.
Details of how the FDA plans to conduct remote evaluations of manufacturing facilities during the COVID-19 pandemic have been set out in guidance published by the US agency.
Biosimilars industry stakeholders have suggested ways to enhance communication and improve the US regulatory pathway for biosimilars, as they weighed in on an interim assessment of the program for enhanced review transparency and communication in the Biosimilar User Fee Act II, ahead of the upcoming reauthorization of BsUFA for fiscal years 2023 through 2027 by the FDA.
Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.
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