Sandoz, a Novartis division, has announced that its biosimilar Tyruko (natalizumab-sztn) has been approved by the US Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS). The disease-modifying therapy, developed by Polpharma Biologics, is a version of Tysabri (natalizumab) and is now the first FDA-approved biosimilar for this patient population. A biosimilar, according to the FDA, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs. “Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of MS,” said Paul Lee, director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research. Tyruko, which is administered ...
By Tristan Manalac Pictured: Novartis office in Switzerland/iStock, Michael Derrer Fuchs The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis. Tyruko is also indicated for inducing and maintaining clinical response and remission in patients with Crohn’s disease with evidence of inflammation, and who are either unable to tolerate or show an inadequate response to conventional therapies. Sandoz is the generics and biosimilars arm of Swiss pharma Novartis, which in August 2022 announced that it was spinning the division off into a standalone entity, scheduled for the fourth quarter of this year. With Thursday’s approval, Tyruko becomes “the first biosimilar product indicated to treat relapsing forms of multiple sclerosis,” Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said in a statement. The regulator’s decision will also contribute ...
With its blockbuster eye drug Eylea, Regeneron is already juggling between a recent FDA rejection and new competition. Meanwhile, biosimilar players are also eying a piece of the pie. Tuesday, Novartis’ Sandoz said its biosimilar to Eylea showed no clinically meaningful differences with the originator in a phase 3 trial in patients with wet macular degeneration. The two versions were therapeutically equivalent in improving the best vision that patients can achieve. Sandoz now expects to file the Eylea biosimilar in the U.S. and EU in the coming months. The Sandoz drug is only the latest copycat to be closing in on Eylea. Viatris was the first to file an Eylea biosimilar in the U.S. in 2021. That asset now belongs to Biocon Biologics through a $3 billion transaction. In addition, the partnership between Formycon and Coherus BioSciences filed its biosimilar in June, followed on the heels by a separate filing ...
Johnson & Johnson (J&J) has reached a settlement with Formycon and Fresenius over their Stelara biosimilar FYB202, setting its US launch date to 15 April 2025. The companies confirmed that they are on track to submit the biosimilar’s biologics license application (BLA) later this year, based on the 7 August announcement. This marks the third settlement reached by J&J and pharma companies that are trying to market Stelara’s biosimilars this year so far. In May, J&J settled its patent lawsuit with Amgen, setting the biosimilar’s launch to no later than 1 January 2025. A month later, J&J reached a settlement with the producers Alvotech and Teva Pharmaceuticals, with a US licence entry date for their Stelara biosimilar AVT04 of no later than 21 February 2025. Also known as ustekinumab, Stelara was first approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to ...
Sandoz, a Novartis division, has announced that its multiple sclerosis (MS) biosimilar has been recommended by the European Medicines Agency’s (EMA) human medicines committee as a single disease-modifying therapy in adults with highly active relapsing-remitting forms of the disease. The “first-of-a-kind” biosimilar natalizumab, developed by Polpharma Biologics, is a version of Tysabri (natalizumab). Biosimilars, according to the EMA, are biological products that are highly similar to a medicine already approved in the EU. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they could potentially lower healthcare costs. Pierre Bourdage, chief commercial officer, Sandoz, said: “Access to affordable, high-quality treatments like disease-modifying therapies – which are a cornerstone in the treatment of MS – remains limited for many people living with this disease.” Over 2.8 million people worldwide are affected by MS, a disabling and unpredictable ...
Sandoz has invested $90m to build a biopharma development centre in Ljubljana, Slovenia by 2026. The site will serve to develop biosimilar products and is expected to create 200 new jobs. This follows Novartis’ financial report stating $2.4bn in net sales for Sandoz biosimilars in Q2 2023, along with the proposed 100% separation of Sandoz from Novartis to form an independent company by the end of this year. The fully independent Sandoz will be headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange and American Depositary Receipt (ADR) programme in the US, as per a 1 June press release. To that end, the development centre is the company’s second major investment in Slovenia. In March, the Novartis spin-off announced plans to construct a biologics production plant in Lendava, Slovenia, to support the increasing product demand. According to a press release, Sandoz chief ...
Sandoz is doubling down on its commitment to Slovenia in its globe-trotting biosimilar growth quest.The Novartis generics unit is plugging $90 million into a new biosimilar technical development center in Ljubljana, Slovenia, where the company aims to hire 200 new staffers. The new site, which Sandoz says will become “key” to its biosimilar development, will feature end-to-end drug substance and drug product development, the company said in a press release Thursday. This isn’t Sandoz’s first foray into the Balkan country. The announcement follows the company’s recent plan to invest a whopping $400 million in a new manufacturing plant there in Lendava. What’s more, Sandoz has already set up prior complex generic development capabilities in Ljubljana. Nearby, the company is also expanding its biosimilar development firepower in Holzkirchen, Germany. The latest move comes shortly after Sandoz unveiled its Act4Biosimilars action plan in June, under which it’s angling to triple global biosim ...
Sandoz, a Novartis division, has announced the US launch of its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) – a biosimilar version of AbbVie’s Humira (adalimumab). Hyrimoz HCF (100mg/mL) is approved to treat all indications that are no longer covered by the reference medicine regulatory exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are highly similar to an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs. Hyrimoz was approved by the FDA in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction compared to the original concentration and can decrease the number of injections required for people who need at least 80mg ...
Boehringer Ingelheim’s new autoinjector pen administering Cyltezo (adalimumab-adbm) is now available to patients living with chronic inflammatory diseases in the US. The Cyltezo pen autoinjector, which is a biosimilar to AbbVie’s blockbuster Humira (adalimumab), received approval from the US Food and Drug Administration (FDA) in May 2023. Boehringer Ingelheim originally received FDA approval for the drug in 2017, and then further approval as an interchangeable biosimilar in 2021. The 40mg/0.8ml pre-filled Cyltezo Pen will be offered in two, four and six-pack options. AbbVie has enjoyed a prosperous monopoly of the adalimumab market with Humira generating $21.2bn in global sales in 2022. With several biosimilars likely to flood the market in 2023 and the company losing exclusivity, AbbVie said it expects its sales of the drug to decline 37% in 2023. Challengers to Humira are now vying for market share. Organon and Samsung Bioepsis launched an autoinjector pen on 1 July, ...
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Humira biosimilar AVT02, further delaying the company’s plans to launch the drug in a landmark year. The agency rejected the drug’s biologics licence application (BLA) over deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland, according to Alvotech’s press release on 28 June. While the FDA did not make a note of any other deficiencies in the BLA, issues related to the Reykjavik facility need to be resolved to facilitate the drug’s potential approval. This marks the second time that the FDA has rejected AVT02’s BLA this year. In April, the regulator issued a CRL to Alvotech, which also noted the deficiencies seen in the company’s Reykjavik plant. Prior to that, the company received a CRL from the FDA over deficiencies in the plant in September 2022. Alvotech plans to resubmit ...
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