Amgen Settles Denosumab Biosimilar Lawsuits with Henlius and Organon

The consent order resolves all claims and counterclaims between the parties.

Apr. 13, 2026 at 10:08am

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A high-end, photorealistic studio still-life photograph featuring a polished glass vial filled with a clear liquid, surrounded by several stainless steel syringes, conceptually representing the pharmaceutical nature of the denosumab drug.Amgen's settlement with Henlius and Organon over denosumab biosimilars marks another milestone in the company's efforts to protect its intellectual property around this key osteoporosis and bone cancer treatment.Boston Today

Amgen has settled its BPCIA litigation against Shanghai Henlius and Organon over their denosumab biosimilars, BILPREVDA® and BILDYOS®. Under the consent judgment, Henlius and Organon agreed that all 26 asserted patents are valid, enforceable, and infringed by their denosumab biosimilars. All remaining claims and counterclaims were dismissed with prejudice.

Why it matters

This settlement follows Amgen's previous settlements with several other companies over denosumab biosimilars, indicating Amgen's continued efforts to protect its intellectual property around the blockbuster osteoporosis and bone cancer drug. The consent order does not specify when Henlius and Organon will be allowed to launch their denosumab biosimilars.

The details

The District Court for the District of New Jersey entered the consent order and judgment on March 31, 2026, following a settlement between the parties. Amgen had brought the BPCIA litigation against Henlius and Organon over their denosumab biosimilars. Under the consent judgment, Henlius and Organon agreed that all 26 asserted patents are valid, enforceable, and infringed by their denosumab biosimilars.

  • The consent order and judgment was entered on March 31, 2026.

The players

Amgen

A multinational biopharmaceutical company and the maker of the branded denosumab products PROLIA® and XGEVA®.

Shanghai Henlius

A Chinese biopharmaceutical company that developed the denosumab biosimilar BILPREVDA®.

Organon

A global healthcare company that developed the denosumab biosimilar BILDYOS® in partnership with Henlius.

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What they’re saying

“This settlement follows Amgen's settlement of denosumab litigations with several other companies, indicating Amgen's continued efforts to protect its intellectual property around the blockbuster osteoporosis and bone cancer drug.”

— Riley Wyberg, Goodwin Procter LLP

What’s next

The consent order did not identify when Henlius and Organon will be allowed to launch their denosumab biosimilars.

The takeaway

Amgen has successfully settled a series of lawsuits over its denosumab patents, protecting its market position for this important osteoporosis and bone cancer drug. However, the consent order leaves open the question of when Henlius and Organon will be able to bring their biosimilar versions to market.