Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, discusses how manufacturers now approach the "patent dance" in light of Sandoz v Amgen.
Transcript:
Have drug makers decided whether is it better for a biosimilar manufacturer to disclose more information upfront, or to abstain from the "patent dance" entirely?
I don’t think we can say that there has been any one consolidated or consistent decision among biosimilar manufacturers as a whole, as far as whether to engage in the patent dance or how far to proceed into it, as there are so many factors that go into the equation making each situation really unique.
However, we can use the data we have collected for BiologicsHQ to look at what has happened particularly since the Sandoz v Amgendecision last June though. Out of all the complaints filed related to proposed biosimilars of CDER-listed reference products, all but 2 of them have stated that the parties at least began the patent dance.
Only 2 of these complaints alleged that the biosimilar manufacturer refused to participate in the patent dance all together, and 1 of those noted that while the biosimilar manufacturer refused to participate in the patent dance, it did later provide access to its [Abbreviated Biologics License Application, aBLA] pursuant to an agreement, although not the patent dance provisions.
Therefore, we are seeing that overall biosimilar manufacturers, generally speaking, have been choosing to disclose at least some information up front. There have been a number of disputes over providing “other” information besides the aBLA and over how quickly and how completely biosimilar manufacturers have given over their aBLAs though.
In fact while most biosimilar manufacturers are providing their aBLAs, few have been willing to turn over all the “other” information about manufacturing the innovators have requested.
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?
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.
Top 5 Most-Read Legal Articles of 2024
December 23rd 2024The top legal stories in biosimilars from 2024 emphasize the ongoing struggle between ensuring timely patient access and addressing challenges like litigation, regulatory hurdles, and patent disputes that shape the competitive landscape of affordable biologics.
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.