Sandoz reaches agreement with Amgen resolving all patent litigation related to its US denosumab biosimilars

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules

Sandoz reaches agreement with Amgen resolving all patent litigation related to its US denosumab biosimilars

• Agreement clears path for launch of Jubbonti and Wyost on May 31, 2025 or earlier under certain circumstances
• Jubbonti and Wyost are first and only FDA-approved biosimilars to and interchangeable with Prolia* and Xgeva*
• Anticipated launch further strengthens Sandoz biosimilar portfolio and advances growth strategy

Basel, April 30, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that it has reached agreement with Amgen to resolve all patent disputes between the two companies relating to the US Food and Drug Administration (FDA)-approved Sandoz denosumab biosimilars.

Patent infringement proceedings were initially filed by Amgen in the US Federal District Court for the District of New Jersey in May of 2023 pursuant to the Biologics Price Competition and Innovation Act (BPCIA). Resolution of the BPCIA litigation followed months of vigorous defense by Sandoz against claims by Amgen that the company infringed up to 21 patents expiring as late as 2037, protecting reference medicines Prolia and Xgeva. Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Prolia and Xgeva on May 31, 2025, or earlier under certain circumstances if customary acceleration provisions are triggered.

Sandoz received FDA approval for the first and only denosumab biosimilars, Jubbonti and Wyost, on March 5, 2024. Jubbonti and Wyost are interchangeable with and approved by FDA for all indications of reference medicines Prolia and Xgeva. They have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.

The settlement clears the path to bring both Jubbonti and Wyost to the US market on May 31, 2025, or earlier under certain circumstances. Bringing denosumab to market allows us to further our Purpose of pioneering access for patients, by providing them with affordable high-quality medicines.

The terms of the agreement will not impact our previously disclosed 2024 guidance.

About Wyost (denosumab-bbdz)
Wyost is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.¹