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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 in Action: Market Shifts, Legal Insights, and FDA Approvals
February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
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.
Biosimilars Gastroenterology Roundup for February 2023—Podcast Edition
March 5th 2023On this episode of Not So Different, we chronicle the latest gastroenterology news from February, including several updates on adalimumab and infliximab biosimilars and industry analyses on the utilization of these drugs and patient confidence in gastroenterologists’ recommendations.
