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Nancy Globus, PharmD, on the Effect of Biosimilar Suffixes
We sat down with Nancy Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs (ACMA), to discuss the true impact that suffixes have on biosimilar perception and whether they are appropriate for the United States.
The use of 4-letter suffixes for biologics has been a source of controversy in the United States since the FDA’s guidance on naming was released in 2015. The guidance stated that all newly approved biosimilars, interchangeable products, and originator biologics would add a 4-letter suffix to the end of the nonproprietary name, or molecule name, of the drug.
However, the FDA revised their guidelines in 2019, and many originator manufacturers were relieved to find that they would not have to add a suffix retrospectively to products already on the market. Although many argued that the suffixes cause confusion, some said suffixes add clarity distinguishing biologics from one another.
We sat down with Nancy Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs (ACMA) to discuss the true impact that these suffixes have on biosimilar perception and whether the United States has the right idea about using them.
To learn more about biosimilar naming, click here.
Click here to learn more about the ACMA.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Biosimilars Policy Roundup for March 2023—Podcast Edition
April 2nd 2023On this episode of Not So Different, we discuss some of the global biosimilar policy news that came out during the month of March, including a new bill in Congress and 2 Canadian jurisdictions implementing switching policies.
AAM's Craig Burton: Is the Biden Administration Doing Enough to Help Biosimilars?
November 13th 2022Craig Burton, senior vice president of policy and strategic alliances at the Association for Accessible Medicines and executive director of the Biosimilars Council, gives insight into the many health policies that the Biden administration has implemented in 2022 as well as their possible impact on biosimilar adoption.
