Denosumab is designed to block a protein called RANKL, stopping bone cells called osteoclasts from breaking down bone in the body. Prolia was first approved by the US Food and Drug Administration (FDA) in 2010 for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Later that year, Xgeva got the FDA green light for the prevention of skeleton-related events in people with bone metastases from solid tumors.
Prolia and Xgeva have been major money makers for Amgen, raking in a respective $999 million and $561 million in the first quarter of 2024. The patents on these drugs expired in many European countries in 2022 and are expected to expire in the US in 2025, opening the way for biosimilars to enter the market.
As part of the agreement, Alvotech will develop and manufacture the biosimilar candidate AVT03 at the company’s Reykjavik facility while STADA will have semi-exclusive commercial rights in Europe in addition to exclusive commercial rights in selected countries in Central Asia and the Middle East, according to a public release.
“We look forward to continuing to work with STADA on increasing patient availability of more affordable biologics in the denosumab market, as we have already done with our citrate-free, high-concentration biosimilar to Humira,” stated Anil Okay, chief commercial officer of Alvotech.
Osteoporosis affected 5.6% of Europeans aged 50 and over in 2019, and the total direct cost of osteoporotic fractures in the EU, Switzerland and UK that year was estimated to be $61.9 billion, according to the International Osteoporosis Foundation.
Humira and Stelara biosimilars at play
At the same time as their latest partnership extension, Stada’s commercial rights to biosimilars to AbbVie’s immunology treatment Humira and Janssen Pharmaceuticals’ gastroenterology, dermatology, and rheumatology therapy Stelara will be extended to Commonwealth of Independent States (CIS) countries in Central Asia, while Stada will pass back to Alvotech the commercial rights to a candidate biosimilar to Eylea.
In 2022, Alvotech and STADA gained the EU green light for their high-concentration citrate-free Humira biosimilar, Hukyndra. In January this year, the partners then gained EU approval for the marketing of their Stelara biosimilar Uzpruvo. Meanwhile, Alvotech and another partner Teva Pharmaceuticals gained US FDA approval of Alvotech’s Humira biosimilar, this time branded as Simlandi, in February.
In March, the US FDA approved Jubbonti and Wyost, the first biosimilars in the US for Prolia and Xgeva respectively. After resolving a legal fight with Amgen, developer Sandoz expects to launch the products into the market in 2025.
