Interchangeability, Meetings And Access Among BsUFA III Priorities
Stakeholders Offer Specific Recommendations On US Biosimilar User Fee Program
Industry stakeholders have offered their views on key priorities for the BsUFA biosimilars user-fee program ahead of its reauthorization.
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Viatris and partner Biocon have seen FDA action on their application for a bevacizumab biosimilar rival to Avastin delayed by the need for a facility inspection, the timing of which is uncertain due to coronavirus-related restrictions.
The FDA has opened registration for a public meeting on reauthorizing the Biosimilar User Fee Act, for fiscal years 2023 through 2027.
To increase transparency and affordability, American billionaire and businessman Mark Cuban has launched a US generics venture under the name ‘the Mark Cuban Cost Plus Drugs Company.’ Cuban’s new company is hoping to introduce over 100 drugs by the end of 2021 and build a pharmaceutical factory of its own by 2022.