- Bone Health
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- Neurology
- Oncology
- Ophthalmology
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Post-Market Pharmacovigilance
Bruce A. Feinberg, DO: Would you still want to be doing pharmacovigilance postmarket release for the Mylan product if, and when, it comes to market?
Hope S. Rugo, MD: There’s no question that pharmacovigilance is incredibly important for all agents. I always tell people, “This is a biosimilar, so it’s very different from using another drug.” But, when you think about it, when any drug goes on the market, pharmacovigilance is incredibly important. In something as simple as a nonsteroidal, we saw a drug go off the market, Vioxx, because of postmarketing vigilance. So, I think that this is very important for all agents, when you have a new product going on the market. And a biosimilar is a new product, so pharmacovigilance is going to be critical. That is part of the regulatory direction for these agents, so pharmacovigilance will be part of this.
In terms of whether the Mylan product will go on the market or not, I think the study met all of the criteria set forth by the regulatory agents. So, it’s more of an issue of production and how production will happen in terms of approval or not. I don’t think there’s any question that these drugs will move forward. And, in the Oncology Drugs Advisory Committee meeting, recently, which was the first to evaluate oncology therapeutics, for both oncology therapeutics that were reviewed— bevacizumab in the morning and our trastuzumab product in the afternoon—there was a 100% vote of “Yes.”
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Adalimumab Biosimilar Switching Policy Shows Long-Term Success in IBD
February 26th 2025Patients with inflammatory bowel disease (IBD) who switched from reference adalimumab (Humira) to a biosimilar under a mandatory nonmedical switching policy maintained long-term safety, efficacy, and treatment persistence comparable to those who remained on the originator drug, according to a Canadian study.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar
February 22nd 2025A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.
