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Novartis' (NVS) Sandoz Gets FDA Nod for Tysabri's Biosimilar
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Novartis’ (NVS - Free Report) generic arm, Sandoz, announced that the FDA approved Tyruko (natalizumab-sztn), a biosimilar of Biogen’s (BIIB - Free Report) leading multiple sclerosis (MS) drug Tysabri. Per Sandoz, Tyruko is the first and only FDA-approved biosimilar for relapsing forms of MS.
Tyruko is approved as monotherapy to treat all indications covered by the branded drug Tysabri for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease, as well as Crohn’s disease in adults. Tyruko has the same intravenous dosage form, route of administration, dosing regimen and presentation as Tysabri.
The FDA approval was based on robust data from phase I and phase III studies. Both studies met primary endpoints and showed that Tyruko provides the same risks and benefits in terms of efficacy, safety and immunogenicity as Tysabri.
MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system that impacts day-to-day lives, and patients experience periods of new symptoms or relapses that improve partially or completely, followed by periods of disease remission.
Sandoz entered into a global commercialization agreement for Tyruko with Polpharma Biologics in 2019, which developed the biosimilar. Per the terms, Polpharma Biologics will maintain responsibility for the development, manufacturing and supply of the active substance in Tyruko. Sandoz has the rights to commercialize and distribute Tyruko in all markets through an exclusive global license.
Shares of Novartis have risen 12.2% year to date compared with the industry’s 7.6% growth.
Image Source: Zacks Investment Research
Earlier in the month, 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.
Sandoz has a leading portfolio with eight marketed biosimilars and a pipeline of 24 compounds in various stages of development.
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.
Tysabri is one of the leading drugs in Biogen’s strong MS portfolio, which also comprises Tecfidera, Vumerity, Avonex, Plegridy and Fampyra. Sales of the Tysabri came in at $955.9 million in the first half of 2023. Hence, the biosimilar approval provides a strong opportunity for Sandoz.
We remind investors that Biogen filed an action in the U.S. District Court for the District of Delaware against Sandoz Inc., other Sandoz entities and Polpharma Biologics S.A. under the Biologics Price Competition and Innovation Act, 42 U.S.C. §262. BIIB sought a declaratory judgment of patent infringement in September 2022 following Sandoz’s announcement that the FDA had accepted its biologics license application for a proposed biosimilar of the drug.
Biogen expects revenues from its MS franchise to decline in 2023 as a result of the increasing competition in both the United States and the rest of the world markets.
Zacks Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Estimates for SPRO’s 2023 loss have narrowed by 39 cents to 51 cents per share in the past 30 days. Spero’s earnings beat estimates in all the trailing four quarters, the average surprise being 72.43%.
Estimates for DVAX’s 2023 loss have narrowed by 27 cents to 24 cents per share in the past 30 days. Dynavax has risen 38.5% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.
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Novartis' (NVS) Sandoz Gets FDA Nod for Tysabri's Biosimilar
Novartis’ (NVS - Free Report) generic arm, Sandoz, announced that the FDA approved Tyruko (natalizumab-sztn), a biosimilar of Biogen’s (BIIB - Free Report) leading multiple sclerosis (MS) drug Tysabri. Per Sandoz, Tyruko is the first and only FDA-approved biosimilar for relapsing forms of MS.
Tyruko is approved as monotherapy to treat all indications covered by the branded drug Tysabri for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease, as well as Crohn’s disease in adults. Tyruko has the same intravenous dosage form, route of administration, dosing regimen and presentation as Tysabri.
The FDA approval was based on robust data from phase I and phase III studies. Both studies met primary endpoints and showed that Tyruko provides the same risks and benefits in terms of efficacy, safety and immunogenicity as Tysabri.
MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system that impacts day-to-day lives, and patients experience periods of new symptoms or relapses that improve partially or completely, followed by periods of disease remission.
Sandoz entered into a global commercialization agreement for Tyruko with Polpharma Biologics in 2019, which developed the biosimilar. Per the terms, Polpharma Biologics will maintain responsibility for the development, manufacturing and supply of the active substance in Tyruko. Sandoz has the rights to commercialize and distribute Tyruko in all markets through an exclusive global license.
Shares of Novartis have risen 12.2% year to date compared with the industry’s 7.6% growth.
Image Source: Zacks Investment Research
Earlier in the month, 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.
Sandoz has a leading portfolio with eight marketed biosimilars and a pipeline of 24 compounds in various stages of development.
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.
Tysabri is one of the leading drugs in Biogen’s strong MS portfolio, which also comprises Tecfidera, Vumerity, Avonex, Plegridy and Fampyra. Sales of the Tysabri came in at $955.9 million in the first half of 2023. Hence, the biosimilar approval provides a strong opportunity for Sandoz.
We remind investors that Biogen filed an action in the U.S. District Court for the District of Delaware against Sandoz Inc., other Sandoz entities and Polpharma Biologics S.A. under the Biologics Price Competition and Innovation Act, 42 U.S.C. §262. BIIB sought a declaratory judgment of patent infringement in September 2022 following Sandoz’s announcement that the FDA had accepted its biologics license application for a proposed biosimilar of the drug.
Biogen expects revenues from its MS franchise to decline in 2023 as a result of the increasing competition in both the United States and the rest of the world markets.
Zacks Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the overall healthcare sector are Spero Therapeutics (SPRO - Free Report) and Dynavax Technologies (DVAX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for SPRO’s 2023 loss have narrowed by 39 cents to 51 cents per share in the past 30 days. Spero’s earnings beat estimates in all the trailing four quarters, the average surprise being 72.43%.
Estimates for DVAX’s 2023 loss have narrowed by 27 cents to 24 cents per share in the past 30 days. Dynavax has risen 38.5% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.