Biosimilars

AbbVie wins a 5-year free pass on mega-blockbuster Humira in biosim settlement with rival Amgen

It was clear from a recent sit-down with Leerink’s Geoffrey Porges that AbbVie was feeling good about keeping its mega-blockbuster Humira franchise in the US to itself through 2022. And this morning we got a peek into why they were so bullish.

Richard Gonzalez

Amgen, which scored the first approval for a biosimilar of Humira in the US, has signed off on a settlement agreement with AbbVie that will delay its rollout until early 2023. Amgen can get started in the EU in the fall of next year, with a marketing pact that calls on the company to pay royalties to AbbVie.

AbbVie’s shares $ABBV shot up 6% this morning.

The details on this deal are being kept under wraps, but the settlement removes one of the most litigious companies in the industry from AbbVie’s pact. As EvercoreISI’s Umer Raffat said in a quick note this morning, the court dates over the patent fight could well have left any final appeals decision until 2021.

AbbVie CEO Rick Gonzalez is eager to make Humira into a $20 billion a year drug before having to compete against biosimilars, and there are at least 10 others in the late-stage pipeline now with virtually everyone in the generic biologics business tackling the king of the market.

The FDA has become quite welcoming to new biosimilar applications over the past year. But getting an approval and carving up market share at two completely different things, as Pfizer found out when it went after J&J’s Remicade. Pfizer’s knockoff barely made a dent in the market, and the pharma giant recently accused J&J of using improper methods in barring competition — a position that J&J says was driven by an embarrassing inability to market the therapy properly.

AbbVie, which has now delayed the lead threat to its biggest cash cow for another five years, was careful not to gloat this morning.

Laura Schumacher, executive vice president, external affairs, general counsel and corporate secretary, AbbVie, had this to say:

In reaching this agreement, we have achieved the balance between protecting investment in innovation and providing access to biosimilars, which will play an important role in our health care system. We will continue to defend our intellectual property and to reinvest in further advancements in medicine to bring choices to patients in need.


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