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.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlighted key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
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.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
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.
How Health Policy Can Impact Adoption for Adalimumab Biosimilars
September 25th 2022In this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, discussed current policy initiatives that could help biosimilar adoption and how the Inflation Reduction Act is expected to influence the adalimumab market.