This year, interviews with industry experts were the most popular among readers of The Center for Biosimilars. Touching on topics like market performance, cost, and government regulations, officials and professionals weighed in on the debates surrounding biosimilars and offered their opinions on how the industry can improve.
This year, interviews with industry experts were the most popular among readers of The Center for Biosimilars. Touching on topics like market performance, cost, and government regulations, officials and professionals weighed in on the debates surrounding biosimilars and offered their opinions on how the industry can improve.
5. Simon Rule, MD: The Impact of Subcutaneous Rituximab on Clinical Practice
Rule of Plymouth University Medical School explains how using subcutaneous rituximab in his own hospital has had a positive impact. Compared to intravenous administration, “the patient has the injection, it takes about 5 minutes, and they can leave,” when providers opt for subcutaneous brand-name rituximab. This increase in efficiency has cut down on time patients and their relatives have to spend in the hospital.
Watch the full interview here.
4. Michael Kolodziej, MD: How Payers Are Preparing for Biosimilars
Kolodziej discusses how the behavior of reference product manufacturers affects payers’ approaches biosimilars. If the reference product manufacturers don’t want to compete on price, Dr. Kolodziej predicts commercial payers, including Medicare Advantage, will enact a policy similar to the use of generic drugs.
Watch the full interview here.
3. Carol Lynch: Barriers to the US Biosimilars Market
In this interview, Lynch, of Sandoz US explains how various barriers inhibit the performance of approved products in the market. Litigation, along with other factors, prevents the expansion of a vibrant biosimilar healthcare system in the United States. She states, “one of the major barriers is actually around the contracting and rebating practices we see from some of the originator companies.”
Watch the full interview here.
2. Scott Gottlieb, MD: Phase 3 Trials and Biosimilars
Gottlieb, former commissioner of the FDA, lays out barriers in the market for biosimilars and discusses increasing efficiency in this interview. “I think there’s always going to be a need to do some level of clinical evaluation and have some component of clinical trials in order to prove the similarity or sameness of the biosimilar to the incumbent biologic, but I think that there are ways to continue to make that process more efficient,” Gottlieb said.
Watch the full interview here.
1. Suzette Kox, MPharm: The FDA's Guidance on Biosimilar Naming
In the most-viewed video from 2019, Secretary General of the International Generic and Biosimilar Medicines Association, Kox, discusses the FDA’s updated guidance for naming biosimilars. Calling the new measures “inconsistent” Kox says she believes they will create confusion among medical professionals.
Watch the full interview here.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
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.
The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability
April 16th 2024Magnus Bodin, senior director and head of international access and policy at Biogen, presented warning signs for unsustainable biosimilar markets as well as key factors needed to create effective policies and future-proof biosimilar markets globally.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.