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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.
Top 5 Most-Read Regulatory Articles of 2024
December 25th 2024In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars referencing ustekinumab, adalimumab, denosumab, and aflibercept, marking key regulatory milestones in improving patient access to cost-effective treatments.
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.
13 Strategies to Avoid the Nocebo Effect During Biosimilar Switching
December 18th 2024A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
