Biocon Strikes Deal with Amgen, Biosimilars Hit U.S. Market
Settlement unlocks osteoporosis and cancer bone treatments for patients.
In a game-changing move for affordable biotech treatments, Biocon Biologics has sealed a landmark settlement and license deal with U.S. giant Amgen Inc., clearing the decks for the U.S. launch of two groundbreaking biosimilars targeting osteoporosis and bone complications from cancer. The agreement, announced Wednesday, resolves a simmering patent dispute and catapults Biocon into America's lucrative bone health arena, promising lower-cost alternatives to Amgen's blockbuster drugs Prolia and Xgeva.
Under the terms, Biocon's Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) gain immediate green light for commercialization starting October 1, 2025—the very day the deal drops. Bosaya, a 60 mg/mL injection in a prefilled syringe, mirrors Prolia's role in fortifying bones against osteoporosis, a condition afflicting millions of postmenopausal women and elderly adults. Aukelso, the 120 mg/1.7 mL powerhouse in a single-dose vial, steps in as a biosimilar to Xgeva, offering relief for cancer patients battling bone metastases and fractures that can derail treatment.
The Bengaluru biotech powerhouse revealed the pact in a regulatory filing, noting it stems from a U.S. District Court battle in New Jersey over patent infringements. "This resolution not only ends the litigation but opens the floodgates for us to deliver high-quality, accessible denosumab options," said Biocon Biologics CEO and Managing Director Shreehas Tambe. He hailed the duo as a "strategic double-whammy," beefing up Biocon's oncology lineup while marking a bold debut in bone therapeutics—crucial as global demand surges for cost-effective biologics amid soaring healthcare expenses.
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Fresh off FDA nods in September 2025, these biosimilars are poised to slash prices by up to 30-40% compared to originals, easing the burden on U.S. insurers and patients. Denosumab, the active ingredient, inhibits bone breakdown by mimicking a natural protein, preventing debilitating fractures and hypercalcemia in cancer cases. With Prolia raking in over $4 billion annually for Amgen and Xgeva adding another $2 billion, Biocon's entry could erode that dominance, injecting competition into a market ripe for disruption.
For Biocon, this isn't just a win—it's a war chest booster. The Indian firm, a trailblazer in biosimilars since its insulin glargine launch, now eyes $200-300 million in peak U.S. sales from these products alone, analysts predict. Shares responded with gusto, climbing 1.88% to Rs 347.25 on the BSE by midday, reflecting investor cheers for the litigation lift and revenue runway.
As Biocon ramps up manufacturing in its sterile facilities, the focus sharpens on supply chain tweaks to meet U.S. demand. Tambe emphasized patient access: "We're not just launching drugs; we're bridging gaps in care, ensuring life-changing therapies reach those who need them most—faster and fairer." With Europe's EMA approvals already in the bag and Asia-Pacific rollouts on deck, this Amgen truce positions Biocon as a global biosimilar heavyweight, ready to challenge pharma titans and democratize advanced treatments worldwide.
