- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Wayne Winegarden, PhD: Why Competition Is Urgently Needed for Enbrel, Humira
Etanercept and adalimumab biosimilar competition is not only necessary to drive down prices, it’s long overdue, according to Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute.
The Center for Biosimilars® interviewed Wayne Winegarden, PhD, senior fellow in business and economics at Pacific Research Institute (PRI) and director of PRI’s Center for Medical Economics and Innovation.
Winegarden said that because of the high costs associated with Humira (reference adalimumab) and Enbrel (reference etanercept), biosimilars of these agents are needed to establish a competitive marketplace and to drive down costs. He said the long exclusivity periods that the makers of Humira and Enbrel have secured must end to allow greater affordability; both drugs are widely utilized in clinical practice.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
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.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
