Novartis' (NVS) Sandoz Gets Rights for Stelara Biosimilar
Novartis’ NVS generic arm Sandoz makes yet another move in its effort to strengthen its biosimilar portfolio. Sandoz entered into a development and commercialization agreement with Samsung Bioepis to commercialize biosimilar SB17.
Biosimilar SB17 is an investigational biosimilar of Johnson & Johnson’s JNJ Stelara (ustekinumab). Stelara is approved for the treatment of autoimmune disorders, including Crohn's disease, plaque psoriasis, psoriatic arthritis and ulcerative colitis. Sales of the drug came in at $5.2 billion.
Per the terms, Sandoz will obtain exclusive rights to commercialize the biosimilar SB17 in the United States, Canada, the EEA, Switzerland and the U.K. The other specific terms of the agreement were not disclosed.
Phase I study results on the biosimilar demonstrated that SB17 matches reference drug in terms of pharmacokinetic bioequivalence, safety, tolerability and immunogenicity. Phase III study results will be presented at a medical congress later this year.
Sandoz has a leading portfolio with eight marketed biosimilars and a pipeline of various compounds in various stages of development.
Per the release, the deal will further strengthen its immunology franchise and Sandoz now expects to have five potential high-value upcoming biosimilar launches over the next few years.
In May, J&J settled litigation with Amgen, as a result of which J&J does not anticipate the launch of a biosimilar version of Stelara until Jan 2025.
Shares of Novartis have risen 9.4% year to date compared with the industry’s 9.1% growth.
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Novartis previously announced that it planned to spin off Sandoz into a new publicly traded standalone company following a strategic review.
The company will conduct a meeting for its shareholders on Sep 15, 2023, in relation to the proposed 100% spin-off of its generic and biosimilar business, Sandoz.
Last month, the FDA approved Tyruko (natalizumab-sztn), a biosimilar of Biogen’s BIIB leading multiple sclerosis (MS) drug Tysabri. Per Sandoz, Tyruko is the first and only FDA-approved biosimilar for relapsing forms of MS.
Tysabri is one of the leading drugs in Biogen’s strong MS portfolio, which also comprises Tecfidera, Vumerity, Avonex, Plegridy and Fampyra. Sales of Tysabri came in at $955.9 million in the first half of 2023. Hence, the biosimilar approval provides a strong opportunity for Sandoz.
In August 2023, Sandoz announced positive results from the phase III MYLIGHT confirmatory efficacy and safety study for the biosimilar of Eylea (aflibercept) in patients with wet macular degeneration. The study met its primary efficacy endpoint and showed no clinically meaningful differences to Eylea. Sandoz expects to file for regulatory approval for biosimilar aflibercept in the United States and the EU in the coming months.
Concurrently, Novartis announced its decision to discontinue the development of GT005 in geographic atrophy secondary to dry-age-related macular degeneration. This decision was based on a recommendation from the independent Data Monitoring Committee following an overall benefit-risk assessment of available data from the program studies, which concluded futility criteria had been met. No new safety signals were identified.
The company is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, in the United States due to crystal formation observed in some bottles, which could potentially result in incorrect dosing.
Novartis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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