Accord Healthcare announced the U.S. launch of two denosumab biosimilars—Osvyrti, a biosimilar to Amgen’s Prolia®, and Jubereq, a biosimilar to Amgen’s Xgeva®—on December 2 2025. The launch follows the expiration of the reference product’s patent on November 27 2025, opening the market to competitors.
The new biosimilars are expected to capture a share of Amgen’s bone‑health franchise, which generated approximately $6.6 billion in sales in 2024 and represented roughly 20% of the company’s total revenue. Early market data suggest that Osvyrti and Jubereq could erode Amgen’s Prolia and Xgeva sales by 10‑15% within the first year, accelerating the decline of these legacy products.
Amgen’s management has acknowledged the biosimilar entry and reiterated its focus on expanding its growth portfolio. The company is investing heavily in its obesity pipeline, particularly the promising MariTide candidate, and has recently secured approval for IMDELLTRA, a treatment for small‑cell lung cancer. These initiatives signal a strategic pivot toward high‑margin, high‑growth segments to offset revenue erosion from mature products.
Both Osvyrti and Jubereq are offered in a prefilled syringe format, a feature that has proven popular with clinicians and patients. The lower‑cost pricing strategy, combined with the convenience of the syringe, positions the biosimilars as attractive alternatives to Amgen’s products, potentially accelerating market share gains.
Accord Healthcare also received EMA approval for Osvyrti and Jubereq in September 2025, underscoring the company’s broader biosimilar strategy. The launch reflects the growing importance of the biosimilar market, which is increasingly eroding originator drug revenues and reshaping the competitive landscape for established biopharmaceutical companies.
The introduction of these biosimilars represents a significant competitive challenge for Amgen’s bone‑health franchise and highlights the broader trend of biosimilar competition reshaping the pharmaceutical industry. For Amgen, the event underscores the need to accelerate its pipeline development and maintain pricing and market‑share advantages in its core therapeutic areas.
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