Amneal Shares Hit 52-Week High on FDA Biosimilar Approval
The drugmaker gains FDA approval for two biosimilars targeting blockbuster drugs Prolia and XGEVA in a U.S. market worth over $5 billion annually.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) shares climbed 2% to a new 52-week high of $12.82 in Monday trading after the company announced it had received U.S. Food and Drug Administration (FDA) approval for two new biosimilar drugs.
The approvals for Boncresa (denosumab-ayda) and Oziltus (denosumab-ayda) reference Amgen’s blockbuster treatments Prolia and XGEVA, respectively. These drugs are used to treat osteoporosis and prevent skeletal-related events in cancer patients, and their reference products command a combined U.S. market of approximately $5.3 billion in annual sales, according to recent market data.
The regulatory green light is a significant step in Amneal's strategy to become a major player in the biosimilar space. The approvals expand the New Jersey-based company’s commercial biosimilar portfolio to five products. In a statement, co-CEOs Chirag Patel and Chintu Patel highlighted the strategic importance of this milestone.
“Biosimilars are the next wave of affordable medicines in the U.S., expanding access to life-changing biologics for millions of patients,” the co-CEOs stated. “We view biosimilars as a major long-term growth vector within our Affordable Medicines segment.”
Amneal, which has a market capitalization of nearly $4 billion, is positioning itself to capture a piece of the lucrative market for biologics as their patents expire. Biosimilars are biologic medical products that are almost identical copies of an original product, offering a pathway to lower healthcare costs.
However, Amneal will face immediate and stiff competition. The company is not the first to enter the denosumab biosimilar market. Sandoz, a division of Novartis, launched the first interchangeable biosimilars to Prolia and XGEVA in the U.S. in June 2025. An 'interchangeable' designation allows a pharmacist to substitute the biosimilar for the reference product without consulting the prescribing physician, which can be a significant commercial advantage. Other pharmaceutical firms, including Celltrion and Samsung Bioepis, have also secured FDA approvals for their own denosumab biosimilars, creating a crowded competitive landscape.
Despite the competition, the approvals represent a key achievement for Amneal's development pipeline. The company has not yet detailed its specific launch and commercialization plans for Boncresa and Oziltus.
Wall Street has maintained a cautiously optimistic outlook on the company. Amneal currently holds a "Moderate Buy" consensus rating from analysts. The successful approval and upcoming launch of these two biosimilars will be a critical test of the company's ability to execute its commercial strategy and deliver on its promise as a key growth driver in the years ahead.