- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Alexandra Valenti, JD: Experience With BPCIA Litigation
Alexandra Valenti, JD, associate at Goodwin, discusses how Biologics Price Competition and Innovation Act (BPCIA) litigation has evolved with greater experience.
Transcript
So, [Biologics Price Competition and Innovation Act, BPCIA] litigation, I wouldn’t say it’s gotten any smoother. Some fundamental questions about how to interpret the statute have now been answered by the federal circuit and the Supreme Court, which certainly leaves fewer unanswered questions that can come up in a district court case.
However, these cases are still very complex. They involve many patents, many more patents than are typical in small-molecule Hatch-Waxman cases, and that has, attendant to it, further complexities in the case. There are usually more experts involved in these cases. The sheer volume of these patents just leads to more proceedings and takes longer to resolve.
And so, these cases are typically taking much longer than we saw on average in the Hatch-Waxman space. So, I wouldn’t say they’re going any smoother or less smooth, but certainly remain very complex litigations to undertake.
PBM Evolution Toward Value-Based Care Shifts to Transparent Pharmacy Pricing
March 30th 2025Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, predict pharmacy benefit managers (PBMs) will evolve toward value-based care, mirroring the broader shift toward open-cost structures.
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?
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
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.
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.
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.
