- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Elaine Blais, JD: Trends in Patent Settlements
Elaine Blais, JD, partner at Goodwin and head of the litigation department in Goodwin’s Boston office, discusses whether a recent spate of patent settlements related to biosimilars reflects a shift away from lengthy Biologics Price Competition and Innovation Act (BPCIA) litigation.
Transcript:
It’s hard to say whether the number of settlements in the biosimilars arena indicate a shift away from lengthy BPCIA litigation. Many of those settlements have been entered into after litigation that some would probably say was lengthy.
And I think it’s a little too early to know how this will shake out. There’s a couple factors at play: One is that the courts and the [Federal Trade Commission, FTC] and Congress have started to pay more attention to settlements in the biosimilar space. We could see activity from anyone of those bodies or from the plaintiff’s bar that might discourage settlements going forward.
We could also see changes in the ways these cases are managed by the courts, or in the risks that both biosimilars manufacturers and the brands face that might impact whether settlements take place. Because of course, generally speaking, a settlement happens when both parties have risks.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Q&A: Dr Kimberly Maxfield Explains How BsUFA III Will Advance the US Biosimilar Industry
December 20th 2023At AMCP Nexus, Kimberly Maxfield, PhD, pharmacologist at the FDA, delved into how the third reauthorization of the Biosimilar User Fee Act (BsUFA III) will shape the American biosimilar market and improve development efficiency over the next few years.
