- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The FDA and Diversity in Clinical Trials
Amanda Forys, MSPH: Do you think the FDA has a position on this? [Should they be] putting more out there on exact guidance for clinical trials, or what they want to see in terms of a mix of patients?
Christy M. Gamble, JD, DrPH, MPH: You know, the FDA, they’ve put out a really standard statement on diversity in clinical trials, but they really haven’t taken a step forward to provide those incentives and to push for that diversity.
I know that groups like mine, we’ve written to the FDA, we’ve spoken to certain individuals at the FDA to say how important it is to really take the lead on this issue, as the FDA, because we’re seeing a lot of drugs and vaccines that are not working in our population. It’s not right and it’s not fair because everyone should be included in the healthcare system.
When you have a group that’s been left out of the healthcare system for centuries now, and they don’t have, currently, access to innovative therapies, it’s disturbing and it’s disheartening.
We really would like for the FDA to be a part of pushing us into this century, so-to-speak, or even this decade would be much better when it comes to access to innovative therapies for all patients.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Early Success of Adalimumab Biosimilars Featured at AMCP 2025
April 5th 2025High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US, particularly in formulary-driven transitions, as shown in 2 retrospective studies presented at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025).
