Over the course of 2018, The Center for Biosimilars® provided coverage of conferences in the United States and abroad. Here is a look at our top 5 conference coverage articles from 2018.
Over the course of 2018, The Center for Biosimilars® provided coverage of conferences in the United States and abroad. Here is a look at our top 5 conference coverage articles from 2018.
5. Once Educated, Patients Generally Receptive to Switching to Biosimilars
At the European League Against Rheumatism’s Annual European Congress of Rheumatology, the patient experience with switching to biosimilars from their reference products was a key topic among stakeholders.
In Australia, researchers reported that patients with rheumatoid arthritis have proven to be receptive to the idea of switching to a biosimilar medicine if their physician recommends doing so. In a single center in the Netherlands, patients reported on how useful the information they were provided about the switch was to them.
4. Lessons From European Biosimilars: Where Have We Been, and Where Are We Going?
During the SMi 9th Annual Biosimilars and Biobetters Conference in the United Kingdom, stakeholders gathered to discuss the state and trajectory of the European Union biosimilars marketplace.
In the early days of the market, said Michael Muenzberg, MD, biosimilar developers had to decide between 2 business models, which he termed a “follow-on model” and a “biogeneric model.” The former involves investing in device design, safety data, and sales and marketing to compete on aspects other than price alone. The latter model, which has not emerged as a dominant option in Europe, is simply to make a product as cheap as possible.
3. Biosimilar Beats Subcutaneous Rituximab on Cost Savings in NHL
The launch of biosimilar rituximab is anxiously anticipated among US healthcare stakeholders who hope to bring down the high cost of intravenously (IV) administered rituximab in the treatment of non-Hodgkin lymphoma (NHL). However, another innovation in rituximab delivery—a subcutaneously administered rituximab formulation—has the potential to save both time and cost.
During the 60th American Society of Hematology Annual Meeting and Exposition, researchers presented findings from a time-and-cost simulation of subcutaneous rituximab (Rituxan Hycela), brand-name IV rituximab (Rituxan), and biosimilar IV rituximab from the US payer perspective.
2. FDA’s Leah Christl Provides an Agency Perspective on the Biosimilars Landscape
Over time, the United States will see a dramatic increase in the number of biosimilar approvals based on the quantity of applications that the FDA is currently receiving, said Leah Christl, PhD, associate director for therapeutic biologics at the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, during the National Policy and Advocacy Summit on Biologics and Biosimilars.
1. Researchers Report Findings on 3 Biosimilar Trastuzumab Products
During the 2018 American Society of Clinical Oncology’s Annual Meeting, researchers presented findings on 3 biosimilar trastuzumab products: Samsung Bioepis’ SB3, Amgen’s ABP 980, Biocad’s Herticad.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
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.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
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.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.