Sandoz And Amgen Resolve Patent Disputes Over FDA-Approved Denosumab Biosimilars In The US
Portfolio Pulse from Benzinga Newsdesk
Sandoz and Amgen have settled all patent litigation concerning Sandoz's denosumab biosimilars in the US, paving the way for the launch of Jubbonti and Wyost on or before May 31, 2025. These are the first FDA-approved biosimilars interchangeable with Prolia and Xgeva, expected to enhance Sandoz's biosimilar portfolio and growth strategy.

April 30, 2024 | 7:56 am
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POSITIVE IMPACT
Sandoz's settlement with Amgen allows for the launch of Jubbonti and Wyost, enhancing its biosimilar portfolio and supporting its growth strategy.
The agreement with Amgen clears a significant legal hurdle for Sandoz, enabling the launch of its denosumab biosimilars, Jubbonti and Wyost. This development is expected to strengthen Sandoz's biosimilar portfolio and contribute positively to its growth strategy by offering alternatives to Prolia and Xgeva, potentially capturing market share and generating new revenue streams.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90
NEGATIVE IMPACT
Amgen's settlement with Sandoz over denosumab biosimilars could impact its market share for Prolia and Xgeva but may also reduce litigation costs.
The settlement between Amgen and Sandoz removes the uncertainty of ongoing litigation, likely reducing legal expenses for Amgen. However, the introduction of biosimilars by Sandoz could lead to increased competition for Amgen's Prolia and Xgeva, potentially impacting their market share and revenues negatively in the short term.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 80