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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
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.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
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.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD
November 16th 2024In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.