AbbVie and Amgen settle Humira clash
AbbVie has settled its patent dispute over Amgen’s proposed biosimilar for Humira (adalimumab), a drug used to treat multiple types of arthritis as well as psoriasis.
Announced yesterday, September 28, the settlement will resolve all pending patent litigation between the parties.
Amgen’s biosimilar, Amgevita/Amjevita, is expected to launch in Europe in October next year and in January 2023 in the US.
Amgen will pay royalties as specified under the agreement.
Scott Foraker, vice president and general manager of biosimilars at Amgen, said: “We look forward to leveraging our existing biologics capabilities to bring high-quality biosimilars to patients worldwide.”
Amgevita will be one of Amgen’s first biosimilar launches and will allow the company to “secure a strong foothold in the $4 billion European adalimumab market”.
Laura Schumacher, executive vice president, external affairs, and general counsel at AbbVie, said: “As an innovation-driven biopharmaceutical company, we believe IP is essential to protect the investment in science and advance novel cures for the toughest health challenges.”
She added that, in reaching the agreement, AbbVie has achieved the “balance between protecting investment in innovation and providing access to biosimilars, which will play an important role in our healthcare system”.
In August last year, LSIPR reported that AbbVie had sued Amgen at the US District Court for the District of Delaware, saying that Amgen’s proposed biosimilar infringes 61 patents.
The dispute arose after Amgen submitted an abbreviated Biologics License Application at the US Food and Drug Administration in November 2015.
On Tuesday, September 26, Amgen announced that it had partnered with Simcere Pharmaceutical Group, a manufacturer of generics, to co-develop and commercialise four biosimilars in China.
The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology.
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