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.
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.