FDA to hold hearing on biosimilars

FDA to hold hearing on biosimilars

The Hill blog is reporting that the US Food and Drug Administration will hold a two-day public hearing with stakeholders to get feedback on creating regulations for so-called follow-on biologics, or biosimilars.

President Barack Obama’s healthcare reform bill included a provision that allows for the approval of biosimilars after 12 years of patent exclusivity.

The hearing will take place November 2 and 3 from 8:30 am to 4:30 pm. Participants must register on or before October 11.

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