April 24th 2024
Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
Semglee Insulin Gains Automatic Approval under BPCIA
June 13th 2020In gaining FDA approval, the insulin glargine product Semglee receives automatic status as a biologic under the Biologics Price Competition and Innovation Act (BPCIA), although it was approved as a 505(b)(2) product under the Food Drug and Cosmetic Act. Semglee becomes the first insulin glargine under the 351(a) pathway.
Physicians Urge FDA to Waive Interchangeability Standard for Insulin Biosimilars
March 30th 2020Two doctors call for interchangeability requirements for biologics to be waived for insulin products under the new regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA) of 2009.
Follow-on Insulin Glargine, Generic Glatiramer Illustrate Medicaid Drug Rebate Issue, Study Says
February 17th 2020Which Medicaid plans benefit the most from the current drug rebate structure and are incentivized to prescribe branded prescriptions? Researchers used the issue of follow-on insulin glargine as well as glatiramer acetate to find out.
Vizient Says It Supports FDA Plan for Insulin Biosimilars, Interchangeable Insulins
January 29th 2020The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.
FDA Releases Draft Guidance on Insulin Biosimilars, Interchangeable Insulins
November 25th 2019The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins. The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.