Amgen, Fresenius Settle Suit Over Prolia, Xgeva Biosimilars (2)

March 10, 2025, 4:53 PM UTCUpdated: March 11, 2025, 1:42 PM UTC

Amgen Inc. and Fresenius SE & Co. settled a lawsuit accusing Fresenius’ proposed biosimilar versions of Prolia and Xgeva of infringing dozens of patents for the blockbuster bone-strengthening drugs.

The agreement dismissed all claims and affirmative defenses Amgen and Fresenius had asserted against each other, but without prejudice, leaving the door open to renewing the allegations, according to Judge Christine P. O’Hearn’s order issued March 7 in the US District Court for the District of New Jersey.

The parties’ “global confidential settlement allows Fresenius to launch its biosimilar products in the US as early as June 30" and in Europe ...

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