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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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
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.
