- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Exceptions Process and its Effect on Patients
Amanda Forys, MSPH: If you said this to a payer, and they said, “That’s what the exceptions process is for,” comment on that a little bit. What does that mean for a patient to go through an exceptions process, what’s the timeline, what’s the stress, what’s the burden of paperwork and evidence that they have to give to the payer?
Christy M. Gamble, JD, DrPH, MPH: For the patient, it’s “Do I really want to go through all of this? I just want access to my medication. I don’t want to have to go through this process of filling out paperwork and talking with my provider, my provider is frustrated, I’m even more so frustrated because I don’t understand what’s going on.”
Like I said, for low-income patients and populations of color, who are not really familiar with these therapies, they’re just going to be really frustrated and say, “Just give me the drug that’s going to take away my frustrations and anxiety.” They tend to go with the outdated therapies, unfortunately, that don’t treat their disease states as effectively as these new therapies. So, [it is a] very frustrating process and one that most people will just give up and move on to the easiest route—like I said, the 5 As of accessibility—and that’s cutting off their access and creating another barrier that they’re not willing to jump over.
A Banner Year for Biosimilars: The 19 FDA Approvals From 2024
January 21st 2025In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.
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.
Biosimilars Drive Cost Savings and Achieve 53% Market Share Across Treatment Areas
January 16th 2025Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ most recent market report, showcasing notable pricing trends and market share disparities across therapeutic areas.
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.
Cost-Efficiency in Action: Denmark's Transition to Biosimilar Adalimumab
January 14th 2025The nationwide mandatory switch from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption.
The Next Frontier: Oncology Biosimilars in 2025 and Beyond
January 13th 2025The US oncology biosimilar market has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.
