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.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
Biosimilar Business News Recap: 3 Biosimilar Application Submissions; Roche Sues Biogen
July 26th 2023Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.
Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?
September 17th 2023On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.