Organon (OGN) Is Up 10.1% After FDA Approves Denosumab Biosimilars for Osteoporosis Market Expansion

• On September 2, 2025, Shanlius Biotech and Organon announced that the US FDA approved their biosimilar products BILDYOS and BILPREVDA, which are biosimilars to denosumab for multiple osteoporosis and bone health indications in the US market.
• This development marks a significant expansion of Organon’s biosimilars portfolio, reinforcing its presence in the osteoporosis treatment landscape and supporting its growth ambitions in the US pharmaceutical sector.
• We’ll examine how the FDA approval of denosumab biosimilars enhances Organon’s investment narrative and outlook for future market expansion.

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Organon Investment Narrative Recap

To own Organon stock, an investor needs to have conviction that the company’s evolving biosimilars portfolio can offset headwinds from declining legacy brands and drive sustainable US growth. The FDA approval of denosumab biosimilars strengthens Organon’s near-term catalysts for revenue expansion, but pricing pressure and mature product reliance remain key risks; the impact of this approval on legacy segment vulnerability is positive but doesn’t eliminate structural concerns.

The recent FDA interchangeability designation for HADLIMA™, a biosimilar to Humira, underscores Organon’s momentum in biosimilars, connecting directly to the same growth catalyst now supported by the US launch of BILDYOS and BILPREVDA. Together, these developments reinforce Organon's intention to capitalize on biosimilar adoption and diversify its revenue base.

However, investors should be aware that rising global pricing pressure and mandatory price revisions for both legacy and new biosimilars could...

Read the full narrative on Organon (it's free!)

Organon's outlook anticipates $6.5 billion in revenue and $990.3 million in earnings by 2028. This scenario assumes 1.2% annual revenue growth and a $290 million increase in earnings from the current level of $700 million.

Uncover how Organon's forecasts yield a $13.17 fair value, a 27% upside to its current price.

Exploring Other Perspectives

Six fair value estimates from the Simply Wall St Community span from US$11.25 up to US$82.78 per share. This diversity highlights how the company’s progress in biosimilars, while promising for future growth, competes with broad concerns about pricing pressure and mature product exposure, inviting you to consider multiple viewpoints before making any decisions.

Explore 6 other fair value estimates on Organon - why the stock might be worth just $11.25!

Build Your Own Organon Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Organon research is our analysis highlighting 3 key rewards and 1 important warning sign that could impact your investment decision.
• Our free Organon research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Organon's overall financial health at a glance.

No Opportunity In Organon?

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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