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Jeffrey Casberg Discusses the Alvotech, AbbVie Settlement Over an Adalimumab Biosimilar


Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discusses the Alvotech/AbbVie settlement for an adalimumab biosimilar and whether it will impact future patent lawsuits.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discusses the Alvotech/AbbVie settlement for an adalimumab biosimilar referencing Humira and whether it will impact future patent lawsuits at the Academy of Managed Care Pharmacy (AMCP) annual meeting.


What do you think that the recent settlement between Alvotech and AbbVie could have for future patent lawsuits, especially for those that may involve the ITC [International Trade Commission]?

Casberg: First, what is the settlement agreement? So, [several] weeks ago, we had a settlement agreement between Alvotech and and AbbVie. Alvotech has a [adalimumab] biosimilar product they're looking to bring to market. AbbVie's the [reference] manufacturer and they'd prefer not to have more competition. But what happened is that both sides had their arguments, but both sides weren't completely sure they would win. And if they did have to go to litigation, the litigation could go on forever, and it could get very expensive.

So, for various reasons, both sides come to a meeting and they say, "Okay, we want this," and they negotiate. They come to a settlement agreement to say, "Okay, we agree that you can launch the biosimilar product, or generic in some cases, on this date." So, that occurred. And the agreement said that alphatech can launch AVT02, the new formulation [referencing] Humira in July 2023.

That changed everything as well, because there was a couple other companies out there, Celltrion Healthcare and Samsung Bioepis/Organon have products. And we hadn't heard much about them. And because we hadn't heard a lot about them, we had figured they probably also had settlement agreements, but weren't saying. So, the information was not publicly available. Now, IPD [Analytics] is assuming that if Alvotech has a settlement agreement with this date, it's likely that Celltrion and Samsung Bioepis/Organon have similar dates.

The settlement agreement is significant because payers can now negotiate with biosimilar manufacturers for both access to original formulation and new formulation products and not have to worry about the conversion effort that would have taken place if only the original formulation came out. So, it changed the game. It's going to make it a lot smoother for payers and a lot better for consumers of the product. It likely will increase adoption of these biosimilar. I think previous to a few weeks ago, adoption would have been modest year 1 [after launch]. I think it will be significantly more than modest now, especially in the second half of the year.

In 2023, we're going to get also interchangeable products. So, for the original formulation we're going to get Cyltezo by Boehringer Ingelheim and Abrilada by Pfizer both launching around July 1 with interchangeability. And then also around July 1, we'll may get the Alvotech/Teva Pharmaceuticals product AVT02 launching with interchangeability. How important is that interchangeability? I guess that's a whole nother session to talk about. So, we'll take that as it comes as [we see] additional launches in 2024 and later.

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