- 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 They tend to go with the outdated therapies, unfortunately, that don’t treat their disease states as effectively as these new therapies.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.
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).
