- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
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.”
Biosimilars Gastroenterology Roundup: March 2025
April 1st 2025As the biosimilar industry celebrates a decade of growth, the market continues to evolve with expanded treatment options, cost savings, and a flurry of new competitors—yet regulatory challenges, market dynamics, and patient accessibility remain key hurdles to unlocking its full potential.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Patients With IBD Maintain Therapy 2 Years Post Switching to Infliximab Biosimilar
March 23rd 2025People with inflammatory bowel disease (IBD) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.
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.
Comparable Pregnancy and Infant Milestones With Infliximab Biosimilars vs Originator in IBD
March 15th 2025A study evaluating pregnancy outcomes and infant developmental milestones found similar outcomes between pregnant women with inflammatory bowel disease (IBD) who received reference infliximab and those who received a biosimilar.
