- Bone Health
- Immunology
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- Diabetes
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- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Not So Different: Nancy Globus, PharmD, on Whether Comparative Efficacy Trials are Necessary
We spoke with Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs, for her take on requirements for comparative efficacy trails and whether they add meaningful data for the purposes of biosimilar acceptance.
There has been much debate recently whether comparative clinical efficacy trials are really necessary for demonstrating that a biosimilar candidate is equivalent to a reference product. Many argue that they contribute little to the weight of evidence available from other testing required by regulatory authorities, such as the FDA and the European Medicines Agency. A recent study of costs of these trials showed that they actually may end up costing more to do than the pivotal trials that led to the approvals of originator drugs.
We sat down with Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs, for her take on these requirements and whether they add meaningful data for the purposes of biosimilar acceptance.
To learn more about the study mentioned above, click here.
To learn more about the United Kingdom's stance on comparative efficacy trials, click here.
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.
