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 They tend to go with the outdated therapies, unfortunately, that don’t treat their disease states as effectively as these new therapies.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.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarized the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.