Alvotech announced that the European Commission has approved its biosimilar AVT03 to denosumab, the reference product for Prolia and Xgeva. The approval covers two presentations: a 60 mg/mL pre‑filled syringe for osteoporosis and a 70 mg/mL vial for cancer‑related bone events, allowing the company to enter the European denosumab market, which is valued at roughly US$1.2 billion annually.
The approval is a key milestone for Alvotech’s growth strategy. Commercialization will be handled by partners STADA and Dr. Reddy’s, who will market the product under the brand names Kefdensis, Zvogra, Acvybra, and Xbonzy. By leveraging local expertise while maintaining its vertically integrated manufacturing advantage, Alvotech positions itself to capture market share in both osteoporosis and oncology supportive‑care segments, which together represent a multi‑billion‑dollar opportunity in Europe.
Alvotech’s Q3 2025 earnings, released on November 13, 2025, revealed a significant EPS miss of $0.03 versus a forecast of $0.47, and a slight revenue shortfall of $114 million versus an expected $115.2 million. The miss was driven by a combination of pricing pressure in the denosumab market, higher than anticipated cost inflation, and a modest decline in sales volume as competitors intensified their own biosimilar launches. The revenue shortfall reflected a 1.1% decline in total sales, largely offset by a 2.5% increase in the oncology segment but a 3.8% drop in the osteoporosis segment, underscoring the competitive headwinds in the market.
Market reaction to the approval was mixed. While Alvotech’s shares rose 1.4% in pre‑market trading on November 24, the broader context of a recent 4.29% decline following the Q3 earnings miss tempered enthusiasm. Investors weighed the positive impact of a new high‑margin product line against concerns about the company’s ability to meet financial expectations and navigate a crowded denosumab biosimilar landscape.
The denosumab biosimilar market in Europe is already populated with several approved products, and Alvotech faces competition from established players and new entrants. In addition, the company is under investigation for alleged securities law violations related to a prior FDA Complete Response Letter for AVT05, adding regulatory scrutiny to its operational challenges. These factors suggest that while the approval expands Alvotech’s portfolio, it must also contend with intensified competition and legal risks.
Robert Wessman, Chairman and CEO, said the approval “demonstrates the continued strength of our end‑to‑end platform and our ability to deliver high‑quality biosimilars at scale.” He emphasized the goal of broadening access to essential treatments and expressed confidence that the partnership model will accelerate market penetration while maintaining cost discipline.
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