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.
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?
FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access
April 28th 2025Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.
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.
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.