HYDERABAD, India - Dr. Reddy’s Laboratories Ltd. and Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted their Biologic License Application (BLA) for a proposed biosimilar of Prolia® and Xgeva®, two drugs used to treat bone-related conditions. The acceptance of the BLA for AVT03, a denosumab biosimilar, marks a significant step in the companies’ efforts to provide an affordable alternative for patients with osteoporosis and other bone diseases.
Developed by Alvotech, AVT03 aims to offer a similar treatment option to Prolia®, prescribed for osteoporosis in postmenopausal women at high risk of fracture, and Xgeva®, used in the prevention of skeletal-related events in patients with bone metastases from solid tumors and multiple myeloma. Both reference products are currently marketed by Amgen Inc.
Dr. Reddy’s, a global pharmaceutical company, and Alvotech, a biotech firm specializing in biosimilars, entered into a License and Supply Agreement in May 2024. Under this agreement, Alvotech is tasked with the development and manufacturing of AVT03, while Dr. Reddy’s is responsible for the commercialization of the biosimilar in the U.S. and other applicable markets.
Upon FDA approval, AVT03 is expected to be available in a single-dose prefilled syringe and a single-dose vial, providing dosing options to suit different treatment requirements. It is important to note that AVT03 is still under investigation and has not yet received regulatory approval in any country.
The collaboration between Dr. Reddy’s and Alvotech reflects a shared commitment to improving patient access to biologic medicines through more affordable biosimilar options. This recent development is a continuation of their efforts to address the needs of a large patient population that requires bone disease treatment.
The acceptance of the BLA by the FDA is based on a press release statement from Dr. Reddy’s Laboratories Ltd. and Alvotech. As the product is still pending approval, healthcare providers and patients are anticipating further updates on the availability of this biosimilar alternative.
In other recent news, Alvogen Pharma US Inc. has received an upgrade in its credit rating from S&P Global Ratings, moving from ’SD’ (selective default) to ’CCC+’. This upgrade follows a debt restructuring transaction that has improved the company’s liquidity and debt maturity profile. Despite this positive development, Alvogen is still seen as dependent on favorable business conditions, particularly the successful launch of several new products, to maintain its capital structure. The company’s top two products currently account for a significant portion of its 2024 revenues, and there are concerns about potential declines in revenue and EBITDA if these are not replaced by new products. Alvogen plans to launch at least four major products over the next two years, although only one is expected to launch by 2026 in a conservative scenario. Meanwhile, UBS has maintained a Buy rating for Alvotech with a price target of $18. The firm projects Alvotech’s sales to reach $1.6 billion by 2028, highlighting potential positive developments with biosimilar Humira and Stelara. UBS suggests that strong sales performance could lead to a reassessment of Alvotech’s market value.
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