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.
FDA Approves Another Pair of Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions, amidst a flurry of similar approvals and legal settlements.
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?
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.
BioRationality: How Developers Can Expand Their Monoclonal Antibody Biosimilar Portfolio
March 24th 2025Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.
Patients With IBD Maintain Therapy 2 Years Post Switching to Infliximab Biosimilar
March 23rd 2025People with inflammatory bowel disease (IBD) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.