Amgen and Biogen settle patent dispute over Prolia and Xgeva biosimilars

[Amgen(Applied Molecular Genetics Inc.) Capability Center in Tampa.]
JHVEPhoto/iStock Editorial via Getty Images

* Biocon Biologics is set to roll out biosimilars targeting Amgen’s (NASDAQ:AMGN [https://seekingalpha.com/symbol/AMGN]) blockbuster bone disease therapies Prolia and Xgeva after resolving a patent dispute with the U.S. pharma giant, the generic drugmaker said on Wednesday.
* The agreement settles a pending patent lawsuit at a New Jersey district court and allows Biocon Biologics, a subsidiary of India’s Biocon, to launch its versions of Prolia and Xgeva, branded as Bosaya and Aukelso, respectively, from Oct. 1 in the U.S.
* Prolia and Xgeva, indicated for osteoporosis and bone-related cancer conditions, have generated $4.3B and $2.2B in product sales for Amgen (NASDAQ:AMGN [https://seekingalpha.com/symbol/AMGN]) in 2024, marking ~8% and ~5% YoY growth, respectively. [https://seekingalpha.com/filing/9557549]
* In September, the U.S. FDA approved Bosaya and Aukelso with a provisional interchangeability designation, which allows pharmacists to dispense biosimilars in place of reference products without the intervention of a healthcare professional. [https://seekingalpha.com/pr/20250539-biocon-biologics-secures-u-s-market-entry-date-for-bosaya-and-aukelso-denosumab-biosimilars]

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