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Dr. Reddy's (RDY), Alvotech Unite for Prolia & Xgeva Biosimilar

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Dr. Reddy’s Laboratories (RDY - Free Report) announced entering into a license and supply agreement with Iceland-based partner, Alvotech (ALVO - Free Report) , for the commercialization of AVT03. AVT03, a human monoclonal antibody, is Alvotech’s biosimilar candidate to Amgen’s Prolia and Xgeva (denosumab).

Both Prolia and Xgeva are currently approved to treat various indications, including osteoporosis in postmenopausal women and prevention of skeletal-related events in adults with advanced malignancies.

The collaboration agreement seeks to leverage Dr. Reddy’s global commercial presence and Alvotech’s proven capabilities in developing biosimilars for markets worldwide.

Per the terms of the agreement, Dr. Reddy’s will be responsible for the registration and commercialization of the AVT03 in the applicable markets, while Alvotech is tasked with the development and manufacturing of the potential product.

Dr. Reddy’s is liable to make an upfront payment to Alvotech, with additional payments upon certain regulatory and commercialization milestones as well as sales-based payments. The exact financial figures have not been disclosed by either of the companies.

The license and supply agreement grants Dr. Reddy’s exclusive commercialization rights for AVT03 in the United States and semi-exclusive for the EU and the UK.

Year to date, shares of Dr. Reddy’s have lost 0.9% against the industry’s 10% rise.

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We would like to remind the investors that in January 2024, Alvotech reported positive top-line results from a pharmacokinetic (PK) study that evaluated the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia in healthy adult subjects.

Currently, Alvotech is conducting a confirmatory efficacy and safety study for AVT03 in patients, as well as a PK study comparing AVT03 to Xgeva in healthy adult subjects.

Dr. Reddy’s markets its current portfolio of biosimilar products in several emerging markets. Most recently, the company launched Versavo (bevacizumab), a biosimilar of Avastin, in the UK. It is indicated for treating several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer.

Versavo is the company’s first biosimilar product to be approved and launched in the UK and is available in dosage strengths of 100mg and 400mg single-use vials.

The collaboration with Alvotech is expected to contribute to Dr. Reddy’s growing portfolio of biosimilar products and allow entry into highly regulated markets. In such markets, its commercial infrastructure is expected to provide Dr. Reddy's with a significant edge over its competitors in delivering best-in-class therapies and affordable treatment options to patients.

Zacks Rank and Stocks to Consider

Dr. Reddy’s currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the drug/biotech industry are ALX Oncology Holdings (ALXO - Free Report) and Annovis Bio (ANVS - Free Report) . Each stock presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73. Year to date, shares of ALXO have lost 8.5%.

ALX Oncology beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.83%.

In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.82 to $1.95. Year to date, shares of ANVS have plunged 56%.

ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.

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