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August 18, 2019Cart

Business

by Fairfield County Business Journal
by FCBJ

Boehringer Ingelheim settles litigation over Humira biosimilar

Boehringer Ingelheim has resolved all intellectual property-related litigation with AbbVie over the latter’s Humira patents, ceding to the latter firm complete control of the marketplace for Humira for the next four years.

Humira is a medication used to treat Crohn’s disease, psoriasis, ulcerative colitis and several forms of arthritis, among other autoimmune diseases. Global sales of Humira hit $19.9 billion in 2018, an 8.2% increase from 2017.

Under the terms of the resolution, North Chicago-based AbbVie will grant BI – the German company whose North American headquarters are in Ridgefield – a nonexclusive license to its Humira-related intellectual property in the U.S. beginning on July 1, 2023. BI’s biosimilar product, Cyltezo, was approved by the U.S. Food and Drug Administration in August 2017 for the treatment of the aforementioned chronic inflammatory diseases.

The settlement will result in BI paying royalties to AbbVie for licensing its Humira patents and acknowledging the validity and enforceability of the licensed patents. AbbVie will make no payments of any form to BI.

“This is an important settlement as it resolves all Humira-related patent litigation in the U.S and provides access for another biosimilar manufacturer seeking to enter the U.S.,” said Laura Schumacher, AbbVie vice chairman, external affairs and chief legal officer.

“We are proud of the role we play in raising public awareness of biosimilars and being able to stimulate competition to bring more affordable treatment options to U.S. patients,” said Sheila Denton, Boehringer Ingelheim senior vicepPresident and U.S. general counsel, legal and government affairs/public policy. “This resolution provides clarity regarding the availability of Cyltezo and allows us to focus on serving patients who need to manage their chronic disease.”

AbbVie has concluded similar deals with a number of other drugmakers for their own Humira biosimilars, including Amgen, Mylan, Sandoz, Samsung Bioepis and Merck, all of whose products will also hit the market in 2023.