- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Tahir Amin: Pay-for-Delay Settlements and Patient Access
Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, discusses how settlements can impact patient access to biosimilars.
Transcript:
What is a “pay-for-delay” strategy, and what effect does it have on generic drugs or biosimilars reaching patients?
So using the Humira example, Amgen recently tried to come into the marketplace with its own biosimilar, and has now settled with AbbVie rather than go through the whole litigation process. Rumor has it that Amgen won’t get into the market until 2023, whereas it could’ve potentially come into the market now. So that’s a classic example of a settlement where litigation is involved.
Today, since the Supreme Court ruling on “pay-for-delay” settlements, we don’t see as many that are coming through, but there are other types of settlements which are happening [that] we don’t know the terms and conditions of. It might not involve money, but it may involve some other incentives or some other payback in a different way which may not be monetary, but could be other ways; we may give you another market but don’t come into the [United States]—it could be various things.
Ultimately, these deals are actually designed to maintain the maximum profit for the brand holder, the patent holder, and give some kind of exclusivity to whoever they’re settling with, but it doesn’t open the market. It allows the control of the marketplace which unfortunately all falls back on the payer and the public.
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.
