A number of notable guests meet The Center for Biosimilars® in 2018 to discuss important developments in this emerging field. Here are the most-watched interviews of the year.
A number of notable guests meet The Center for Biosimilars® in 2018 to discuss important developments in this emerging field. Here are the most-watched interviews of the year.
5. What Biosimilar Developers Should Know about the Rheumatic Disease Community
Seth Ginsberg, cofounder and president of the Global Healthy Living Foundation, explains how biologics have improved treatment for rheumatic diseases, and what biosimilar developers should know about the patient community that their product serve. Ginsberg calls for all stakeholders to work together to make sure that biosimilars can help patients achieve clinical benefits and cost-savings.
4. The FTC and Biosimilar Competition
Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses the role that the Federal Trade Commission (FTC) may play in encouraging biosimilar competition. Lassman describes the actions that the FTC has taken so far, and how the agency has played a role in clarifying questions about the Hatch-Waxman Act.
3. Using Biosimilar Filgrastim
Howard Cohen, RPh, MS, FASHP, director of oncology pharmacy services for Yale New Haven Hospital, discusses using biosimilar filgrastim. Cohen reports that his system has created an approval process for biosimilars, and has adopted Zarxio in place of Neupogen.
2. The Manufacturer’s Challenges in Getting Biosimilars to Market
Sheila Frame, vice president and head of biopharmaceuticals, North America, Sandoz, discusses the challenges that biosimilar developers face in getting their products to market. Frame highlights the roles of intellectual property disputes and policy challenges in the US market.
1. FDA and FTC Cooperation to Address Anti-Competitive Behavior
Ha Kung Wong, JD, then a partner at Fitzpatrick, Cella, Harper and Scinto, and now a partner at Venable, discusses how the FDA and FTC may work together to address anticompetitive behavior in the biosimilars marketplace. Wong highlights Risk Evaluation and Mitigation Strategies, settlements, and antitrust lawsuits as areas to watch.
BioRationality: Biosimilar Associations and Stakeholders Representing Biosimilars
January 20th 2025Sarfaraz K. Niazi, PhD, dives into the role that biosimilar associations and organizations play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.
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.
Functional Similarity Between Ustekinumab Biosimilar ABP 654, Stelara in Crohn Disease
January 18th 2025Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.
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.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.