- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Elaine Blais, JD: The Potential for US Patent Reform
Elaine Blais, JD, partner at Goodwin and head of the litigation department in Goodwin’s Boston office, discusses whether the US patent system is likely to see reform in the near future.
Transcript
I think it’s likely that we’ll see significant proposals around patent reforms from some of the discussions that are going on at this point. I think it’s unlikely that we’ll see significant reforms anytime soon. And I say that not because I’m making a substantive decision about whether reforms are needed, but because history tells us that patent reform is slow and methodical, and I don’t expect it to be any different here.
The issue with patent reform is [that] one stakeholder’s dream reform might be a nightmare to another stakeholder. And we know from our prior iterations of patent reform that there will be many of discussions, lots of attempts to balance out interests of different parties, and especially in this Congress where there’s a lot of disagreement, I think it could be a lot of delay before we see anything significant happening in Congress. Looking to the courts is probably going to be a better opportunity for reforms that will have an impact on [Biologics Price Competition and Innovation Act, BPICA] litigation.
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.
