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Elaine Blais, JD: Helsinn v Teva and Its Implications for Biosimilar Developers
Elaine Blais, JD, partner at Goodwin and head of the litigation department in Goodwin’s Boston office, discusses the Supreme Court’s January 2019 decision in Helsinn v Teva.
Transcript:
The Supreme Court’s January 2019 decision in Helsinn v Teva is an important decision for biologics manufacturers and biosimilar companies. In that case, which was argued by our partner [William Jay, JD], the Supreme Court held that an inventor's sale of an invention to a third party could trigger the statutory on-sale bar even where the third party was obligated to keep the invention confidential.
This case has important implications for biosimilar manufacturers in that it is a warning that they need to be very careful about the types of contracts they enter into prior to applying for a patent. And it is an opportunity for biosimilar manufacturers in that it opens the door for potential on-sale defense invalidity argument, and biosimilar manufacturers should be careful to investigate and take appropriate discovery to determine whether such a defense is viable in any given case.
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.
