- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- 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.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
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 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.
