Sandoz has achieved a significant milestone in its pursuit to challenge Amgen's blockbuster osteoporosis franchise, announcing positive clinical trial results for its denosumab biosimilar. The ROSALIA phase 1/3 study demonstrated that the biosimilar matched Amgen's Prolia across multiple critical parameters in postmenopausal women with osteoporosis.
The comprehensive trial evaluated pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity measures, with results indicating therapeutic equivalence to the reference product. This development positions Sandoz to pursue regulatory approvals in major markets as patent protections expire.
Market Impact and Patent Landscape
The timing is particularly significant as denosumab patents have already expired in several European markets, though protection remains in France, Italy, Spain, and the UK until 2025. The U.S. market, which represents two-thirds of Prolia's $3.25 billion annual sales, will also open to competition in 2025.
For Amgen, the stakes are considerable. Beyond Prolia's substantial revenue, the company generates an additional $2 billion from Xgeva, a higher-dose denosumab formulation used in oncology settings for bone metastases and cancer-related hypercalcemia. Together, these products represent a crucial portion of Amgen's revenue stream.
Competitive Landscape and Strategic Response
Florian Bieber, global head of development for Sandoz Biopharmaceuticals, emphasized the broader implications: "This important milestone means that we are one step closer to giving individuals living with osteoporosis access to a more affordable, biosimilar version of this critical medicine, which may help to change the course of their disease."
Amgen isn't standing still in the face of this challenge. The company has been building its osteoporosis portfolio with Evenity (romosozumab), developed in partnership with UCB. This anti-sclerostin antibody, approved in 2019, showed promising growth with $530 million in sales last year, marking a 50% increase.
Broader Biosimilar Competition
The competitive landscape extends beyond Sandoz, with Samsung Bioepis, Celltrion, and AryoGen Pharmed also developing denosumab biosimilars. This comes at a challenging time for Amgen, which faces patent expirations for other key products including Enbrel and Otezla, collectively representing over 40% of current revenues.
Regulatory Environment Evolution
In a significant development for the broader biosimilar market, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have issued a joint statement declaring all EU-approved biosimilars interchangeable with their reference medicines. This harmonization across EU member states eliminates a key barrier to biosimilar adoption, potentially accelerating market penetration and patient access to more affordable treatment options.
