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Dr Steven Yates Shares His Institutions's Policies on Nonmedical Switching and New Biosimilar Starts
Steven Yates, MD, discusses Intermountain Healthcare's policies surrounding switching patients from reference products to biosimilars.
The Center for Biosimilars® interviewed Steven Yates, MD, a medical oncologist and medical director at Intermountain Healthcare in Las Vegas, Nevada. Three years ago, Intermountain hired him to lead its biosimilar adoption effort.
Dr Yates describes Intermountain’s experience with switching patients to biosimilars vs initiating biosimilar treatment only for biologics-naïve patients. Early on, Intermountain did not switch patients from reference products until their course of therapy was complete. Intermountain is now 100% biosimilar focused, Yates says. Strong patient support is employed to build acceptance for biosimilars, and patients are asked for consent prior to a biosimilar switch. Yates says the institution has experienced little pushback, and the resistance that has occurred has been mostly over reimbursement issues, where patient assistance programs have preferred use of reference products.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.
FTC Releases Second Report on PBMs Meddling in Generic Drug Markets
January 19th 2025The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.
