2023 Year-End Reflections
A quarterly note from BBCIC Executive Director Cate Lockhart, MS, PharmD, PhD.
Dear BBCIC Participants and Supporters,
As we close out yet another year-in-the-life as a consortium, the EIGHTH year-in-the-life in fact, I always enjoy reflecting on all we have accomplished in the past twelve months. While we are in the middle of it, it is hard to see the forest for the trees, but when we look back at the year it always amazes me how much we are able to accomplish! I’ll share a few highlights here:
- We started out the year strong with a publication in the Journal of Medical Economics describing the methodological challenges we overcame in identifying cohorts of patients receiving multi-agent chemotherapy regimens for our G-CSF comparative safety and effectiveness work. Since then, we have two additional publications (Insulin utilization; infliximab switching literature review) and a third in peer-review (rituximab real-world research literature review).
- Throughout the year we completed our work on our ambitious G-CSF biosimilar comparative safety and effectiveness project and are finalizing the research report and anticipate submitting at least two manuscripts in early 2024.
- We made great progress on our first FDA-sponsored grant in which we have been conducting a comprehensive literature review describing the use of real-world data in regulatory decisions globally, and took a deep-dive into how FDA may consider using real-world data for biosimilar decisions. We presented our first grant-related poster at ISPOR Europe (November, 2023, Copenhagen, Denmark) describing some of our literature findings. Our report for these “Aim 1” activities is in preparation and we are planning several abstract submissions and related manuscripts.
- We were awarded a second grant!! The project entitled “Bridging the Gap: Using Foreign Real-World Data to Inform Interchangeable Biosimilar Approvals” was selected for funding by the FDA as part of the BsUFA III Regulatory Sciences Program, the source of funding for our existing grant. We have partnered with colleagues from Italy and Denmark to explore how non-US data could be used for biosimilar regulatory assessments.
- BBCIC doubled in size in mid-2023 and we are now a might team of FOUR staff members!
- We presented two posters describing our work on medication switching patterns, and that project is continuing into 2024 with additional analyses from the rich data set created for this project.
- We launched a new project: “Biosimilar Access and Utilization” that will begin in earnest in 2024.
As always, we have a lot going on, and I have to say CONGRATULATIONS to all of BBCIC for your ongoing support, enthusiasm, and perseverance to continue to produce high-quality, important research. And I have to say THANK YOU for all those same reasons. We are tiny but mighty!
It takes a village to raise a consortium, and we are grateful for your continued support and engagement!
Cate Lockhart, MS, PharmD, PhD