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AbbVie allows Fresenius Kabi's Humira biosimilar in Europe now, US in 2023

AbbVie Inc. has granted Germany's Fresenius Kabi AG the rights to sell a biosimilar version of its blockbuster drug Humira in Europe and the U.S., making it the fifth company to gain such a license.

Fresenius can market its copy of Humira once it secures European approval but must wait until September 2023 to launch it in the U.S. AbbVie will receive confidential royalties for granting the nonexclusive license.

Biosimilars are copy-cat versions of branded biologic drugs, which are often injectable or infused treatments derived from living cells. And new laws in the U.S. and Europe have allowed more and more biosimilars to enter the market as a means to promote competition and lower prices in the space. In the U.S. especially, legal disputes have made it difficult to launch biosimilars due to ambiguities in the 2009 Biologics Price Competition and Innovation Act. The disputes often result in settlements like AbbVie's.

"This agreement is a major step on our way to successfully developing and commercializing our biosimilar portfolio," Michael Schönhofen, Fresenius' president of the Pharmaceuticals division, said in an Oct. 18 press release. "The agreement with AbbVie provides further clarity regarding when we will be able to commercialize our biosimilar candidate of Humira."

AbbVie has reached similar settlements with four other Humira biosimilar makers, granting a European entrance date of Oct. 16 to Amgen Inc., Samsung Bioepis Co. Ltd., Mylan NV and Novartis AG, all of which have European approval. AbbVie is set to receive undisclosed royalties for all of its Humira settlements, which allow for staggered launches in the U.S. in 2023.

Of those that reached a deal with AbbVie, only Amgen's Amgevita, Samsung's Imraldi and Novartis' Hyrimoz have been launched in Europe. Mylan did not respond to inquiries whether or not it had launched or plans to launch its Humira biosimilar in Europe.

Boehringer Ingelheim GmbH has also been granted regulatory approval in Europe, but it did not reach a resolution with AbbVie, as the companies are still locked in a patent suit.

AbbVie's Humira pulled in $18.4 billion for the company in 2017, accounting for two-thirds of its revenue. It was also the best selling drug in the world that year.

Humira