• Regulatory NewsRegulatory News

    BsUFA II: What’s Coming for Biosimilar Sponsors from FY 2018 Through FY 2022

    A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase. FDA Commissioner Robert Califf opened the public hearing with comments on how the agency is still trying to find the righ...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Formal Meetings with Biosimilar Sponsors

    The US Food and Drug Administration (FDA) on Wednesday plans to release finalized guidance on formal meetings between FDA and biosimilar sponsors. The agency said that as a result of the public comments on the draft guidance from April 2013, information has been added “to provide clarity on the process for requesting meetings, including identifying the appropriate meeting type and the data expectations to support the appropriate meeting type.” The Generic Pharmaceut...