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Novartis (NVS) Unit Posts Positive Results on Prolia Biosimilar

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Novartis (NVS - Free Report) has announced that its generic and biosimilars unit, Sandoz, released positive results from the integrated phase III ROSALIA study for its proposed biosimilar of Amgen’s (AMGN - Free Report) Prolia (denosumab).

We remind investors that Prolia is indicated for treating a variety of conditions, including osteoporosis in postmenopausal women, in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal-related complications in cancer that has spread to the bone and giant cell tumor of the bone.

The ROSALIA study randomized 527 postmenopausal women with osteoporosis to receive either biosimilar denosumab or the branded drug for up to 78 weeks of treatment. The objectives were to demonstrate similar efficacy in terms of change in lumbar spine bone mineral density, as well as similar pharmacokinetics and pharmacodynamics.

The study met primary endpoints showing proposed biosimilar denosumab matched the branded drug in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis.

Amgen recorded Prolia sales of $922 million in the second quarter of 2022, up 13% year over year.

Osteoporosis is a promising space as it accounts for 8.9 million bone fractures annually, including debilitating hip fractures – a number set to increase substantially over the next two decades.

The going has been good for Sandoz’ biosimilars pipeline. In July 2022, the company’s application for the proposed biosimilar of Tysabri (natalizumab) for the indication of multiple sclerosis was accepted for review by the FDA and European Medicines Agency (“EMA”). In June 2022, the EMA and FDA also accepted for review Sandoz's applications for the high-concentration formulation 100 mg/mL (HCF) of its biosimilar Humira.

Shares of Novartis have lost 7.7% so far this year compared to the industry’s decline of 4.1%.

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Last month, Novartis announced plans to spin off Sandoz into a new publicly traded standalone company to separate this business following a strategic review. This was because industrywide price competition among generic pharmaceutical companies and consolidation of buyers caused significant declines in sales and profits of Sandoz, particularly in the United States.

Sandoz generated $9.6 billion in sales in 2021.  Concurrent with second-quarter earnings, management stated that the generic business showed signs of recovery.

The separation will enable Novartis to focus better on its legacy pharmaceutical business. Novartis had earlier spun off its eye care division Alcon into a new company.

Novartis carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Sanofi (SNY - Free Report) and Bolt Pharmaceuticals (BOLT - Free Report) . Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Earnings estimates for Sanofi are up 4 cents each for 2022 and 2023. Sanofi surpassed estimates in all of the trailing four quarters, the average being 9.37%.

Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.


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