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Alexandra Valenti, JD: Biosimilar Versus Biosimilar Suits


Alexandra Valenti, JD, associate at Goodwin, discusses a recent case in which one biosimilar developer sued another over adalimumab.


So recently, Coherus did sue Amgen on patents it has on an adalimumab formulation. Both companies in the litigation are biosimilar manufacturers, so it’s a little bit atypical from our average [Biologics Price Competition and Innovation Act, BPCIA] litigation where the plaintiff in the suit is the branded biologic manufacturer.

The suit is interesting from a strategic standpoint because Coherus is one of the settling adalimumab manufacturers along with Amgen. And under those settlement agreements, Amgen is set to be the first adalimumab biosimilar launch in the United States in January of 2023. Coherus won’t launch until December 2023 under its agreement, and so the suit presents and interesting scenario because all Coherus can really hope to achieve is to keep 1 of 7 potential biosimilar competitors off the market, that being Amgen, if it is successful in the suit. Amgen again, being the first to launch. And so, it is an interesting case from that perspective to understand what Coherus is hoping to achieve with the suit.

In terms of whether we think this is going to be a trend that will continue, there are certainly experiences from the small molecule Hatch-Waxman litigation space where there were generic versus generic suits. But, many of those suits weren’t successful. Of the suits that I and my colleagues are aware of, none resulted in a finding of infringement. And so, none resulted in a ruling that would have kept one of the generics off of the market.

And so, I think it’s reasonable to assume that we will see more biosimilar versus biosimilar cases. Biosimilars by their nature do not have to match the biologic to the extent that a small molecule will, and so it does open up, due to the complexity of the molecules, opportunities for biosimilar manufacturers to pursue patents on processes, different formulations, and other aspects of their products that may not already be patented by the biologic. So, I think we will see more of these suits, and the question will be how successful will they be and what will their effects be on the market landscape.

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