• FDA approves first interchangeable biosimilar insulin

    1 month ago - By Healio

    The FDA approved the first interchangeable biosimilar insulin product to improve glycemic control for children and adults with diabetes, part of an effort to provide cost-effective options, according to an agency press release.
    Semglee is both biosimilar to and interchangeable with its reference product insulin glargine , a long-acting insulin analogue. As Healio previously reported, Semglee was approved as a drug product under the 505(2) NDA pathway and is now deemed a biologic under section 351, in accordance with the Biologics Price
    Read more ...

     

  • FDA OKs First Interchangeable Insulin Biosimilar

    FDA OKs First Interchangeable Insulin Biosimilar

    1 month ago - By MedPageToday

    The FDA approved Semglee as the first interchangeable biosimilar insulin product for diabetes, allowing for pharmacy-level substitution in states that allow it, the agency announced on Wednesday.
    "This...
    Read more ...