New deal staves off Humira biosimilar competition

A new deal between pharma giants AbbVie and Samsung Bioepis is designed to postpone competition against Samsung a biosimilar to Humira until 2023.

Samsung Bioepis signed a licensing agreement with AbbVie, which settles all pending patent litigation between the 2 companies and clears the way for the worldwide commercialization of  Samsung Bioepis’ SB5, a biosimilar referencing adalimumab (Humira), in all approved markets worldwide.

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Humira, the blockbuster drug that treats rheumatoid arthritis, raked in more than $18 billion in sales last year and accounted for nearly two-thirds of AbbVie’s net revenue, according to Reuters.

Under the terms of the new deal, SB5 may be launched in Europe from October 16, 2018, onwards and, if approved, in the United States, from June 30, 2023, onwards. AbbVie previously announced a global resolution with Amgen allowing its biosimilar to Humira to enter the US market on January 31, 2023.

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SB5 has been granted marketing authorization by the European Commission (EC) as Imraldi, and will be commercialized in Europe by Biogen.                  

“The earliest impact of this agreement will likely be seen in Europe, where SB5 has already been approved and is expected to become our third TNF inhibitor available in the region,” said Jaywoo Kim, senior vice president and head of the commercial division at Samsung Bioepis, in a statement.

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