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.
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.
From Approval to Practice: Addressing the Hurdles in Biosimilar Integration
December 18th 2024Recent discussions at an Institute for Value-Based Medicine event highlighted the significant potential of biosimilars in reshaping the health care landscape, despite facing considerable barriers to adoption.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.