Latest news with #Selarsdi
Yahoo
17-06-2025
- Business
- Yahoo
Teva to collaborate with Fosun Pharma for TEV-56278
Teva Pharmaceutical has announced a collaboration with Shanghai Fosun Pharmaceutical (Fosun Pharma) to advance the global development of the anti-programmed cell death protein 1 (PD1)-Interleukin-2 (IL2) ATTENUKINE therapy, TEV-56278. The collaboration will enhance clinical data generation for the potential treatment, which utilises Teva's ATTENUKINE technology designed to offer efficacy with low toxicity across various oncology indications. Teva Global research and development (R&D) executive vice-president and chief medical officer Eric Hughes stated: 'This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring the acceleration of our pipeline. 'TEV-56278 demonstrates the strength of Teva's innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients.' Fosun Pharma will have exclusive rights to develop, manufacture and commercialise the therapy in Mainland China, the Hong Kong Special Administrative Region (SAR), Macau SAR, the Taiwan region and selected countries in Southeast Asia. Teva retains all corresponding rights outside of these territories. The deal provides the company with insights from Fosun Pharma's regional data that can be leveraged globally. Fosun Pharma executive president and global R&D centre CEO Xingli WANG stated: "We are pleased to partner with Teva on the development of TEV-56278. "This collaboration brings together Teva's expertise in innovative drug development with Fosun Pharma's strong oncology development experience and commercial capabilities in the China market, creating a powerful synergy to accelerate the delivery of this important therapy to patients globally." TEV-56278 has been specifically engineered to target PD-1 + T cells selectively. This targeted method could significantly improve patient outcomes across multiple oncology diseases. In February 2025, Teva and Alvotech have announced the US launch of the Selarsdi (ustekinumab-aekn) injection, a biosimilar to Johnson & Johnson's Stelara (ustekinumab). "Teva to collaborate with Fosun Pharma for TEV-56278" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-05-2025
- Business
- Yahoo
FDA approves Selarsdi injection as interchangeable with Stelara
Teva Pharmaceuticals and Alvotech have announced that the US Food and Drug Administration (FDA) has approved the Selarsdi (ustekinumab-aekn) injection as interchangeable with reference biologic Stelara (ustekinumab). As of 30 April, Selarsdi is now available and interchangeable in all presentations that correspond with Stelara, including the treatment for both adult and pediatric patients with psoriatic arthritis, plaque psoriasis, ulcerative colitis, and Crohn's disease. Selarsdi's approved presentations include a subcutaneous injection with 45mg/0.5ml and 90mg/ml in a single-dose prefilled syringe, as well as 45mg/0.5ml in a single-dose vial. The approved presentation is also for intravenous infusion with 130mg/26ml in a single-dose vial. Teva Pharmaceuticals US biosimilars senior vice-president Thomas Rainey said: "The FDA's confirmation of full interchangeability for Selarsdi is an important development for patients and providers seeking to expand access to this important treatment. "Teva's recent launch of two biosimilars – Selarsdi and Epysqli – coupled with a rich pipeline of assets expected to launch over the next few years, position Teva to establish a strong leadership position in the growing landscape of biosimilars and to drive growth for the company as it embarks on the next phase of its strategy." Ustekinumab, the active component in Selarsdi, is a human monoclonal antibody (mAb) that targets the p40 protein. This protein is a shared component of interleukin (IL)-12 and IL-23 cytokines, which are critical in treating immune-mediated conditions such as psoriasis and psoriatic arthritis, as well as inflammatory conditions such as ulcerative colitis and Crohn's disease. Alvotech developed and produces Selarsdi, leveraging Sp2/0 cells and a continuous perfusion method. The injection has been approved as Selarsdi in the US and introduced under various names in different regions, including Jamteki in Canada, Uzpruvo in Europe, and Ustekinumab BS (F) in Japan. Applications are being reviewed in several nations worldwide. The strategic partnership between the companies, initiated in August 2020, was established for the exclusive commercialisation of five biosimilar product candidates of Alvotech. In July 2023, the collaboration expanded to include two additional biosimilars and new presentations of two previously collaborated products. Including Selarsdi, the companies have seen two biosimilars developed by them gain US regulatory approval with interchangeability. Alvotech and Teva noted that they have three additional biosimilar candidates under review by the US regulator: a proposed biosimilar for Simponi (golimumab) and Simponi Aria (golimumab), AVT05, and AVT06, which is a proposed biosimilar for Eylea (aflibercept).
Yahoo
25-02-2025
- Business
- Yahoo
J&J sues Samsung Bioepis over Stelara biosimilar
By Sneha S K and Patrick Wingrove (Reuters) - Johnson & Johnson sued Samsung Bioepis for allegedly breaching a contract agreement over its launch of a biosimilar to Stelara, J&J's blockbuster psoriasis treatment. The lawsuit, filed late on Monday in a New Jersey federal court, involves an unauthorized sublicense deal with a private label provider that J&J declined to identify. The suit seeks a preliminary injunction to bar U.S. sales of the private-label version of Samsung Bioepis' Stelara biosimilar, called Pyzchiva. Samsung and J&J signed a settlement agreement in July 2023 allowing for the launch of Pyzchiva this month. Samsung Bioepis and partner Sandoz announced earlier on Monday that Pyzchiva had been launched in the U.S. J&J in the lawsuit claimed that the agreement did not permit Samsung to introduce an additional private label drug at the expense of J&J market share and fair competition. It also requested a permanent injunction and financial damages as part of its lawsuit. Samsung Bioepis did not immediately respond to a request for comment on the lawsuit. Stelara, introduced in 2009, has been J&J's top-selling drug since 2019, with sales reaching more than $10 billion in 2024. Its patents began to expire in 2023, opening the door to cheaper biosimilars entering the market. Legal agreements aimed at escaping lengthy patent litigation delayed market entry of Stelara biosimilars in the U.S. J&J Chief Financial Officer Joe Wolk has said the Stelara biosimilar market was likely to unfurl similarly to that of AbbVie's blockbuster arthritis drug Humira - once the world's best-selling prescription drug - given contracting practices and doctor and patient resistance to switching medicines. AbbVie held onto almost all of the Humira market for more than a year after close copies of the drug were launched in early 2023. That changed when CVS Health removed Humira from its list of covered drugs and more patients switched to a biosimilar in three weeks than had in the prior 15 months. CVS, which owns a pharmacy benefit manager that negotiates rebates and fees with manufacturers and creates lists of medications, known as formularies, that are covered by insurance, replaced Humira with a biosimilar that was jointly marketed with its Cordavis unit, a private label provider. J&J in its lawsuit said Humira's market erosion was illustrative of the harm Samsung Bioepis' private label deal could have. Stelara biosimilars launched in Europe, Canada and a few other markets last year, and at least seven close copies of Stelara are expected to begin selling in the U.S. this year. Pyzchiva is approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. Teva Pharmaceuticals and Alvotech last Friday launched Selarsdi, a biosimilar to Stelara. The U.S. Food and Drug Administration has allowed the use of Selarsdi as an "interchangeable" Stelara substitute only after April 30, when the exclusive rights for Amgen's version Wezlana expire. Sign in to access your portfolio
Yahoo
24-02-2025
- Business
- Yahoo
J&J sues Samsung Bioepis over contract breach for Stelara biosimilar
(Reuters) - Johnson & Johnson said on Monday it had filed a lawsuit against Samsung Bioepis for breaching its contract agreement with the drugmaker over the launch of a biosimilar to Stelara, J&J's autoimmune drug. J&J said it is seeking a preliminary injunction for Samsung Bioepis' close copy of Stelara over an unauthorized sublicense deal with a private label provider, which the drugmaker declined to identify. The company, along with partner Sandoz, said earlier on Monday that its biosimilar Pyzchiva is now available in the United States. J&J over the past two years has signed settlement agreements with several companies to delay the U.S. launches of Stelara, its top-selling drug since 2019. Close copies of Stelara launched in Europe, Canada and a few other markets last year and at least six close copies of Stelara are expected to launch in the U.S. this year. Teva Pharmaceuticals and Alvotech last Friday launched Selarsdi, a biosimilar to Stelara. The U.S. Food and Drug Administration has allowed the use of Selarsdi as an "interchangeable" substitute only after April 30, when the exclusive rights for Amgen's Wezlana expire. Pyzchiva is approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. Sign in to access your portfolio
Reuters
24-02-2025
- Business
- Reuters
J&J sues Samsung Bioepis over contract breach for Stelara biosimilar
Feb 24 (Reuters) - Johnson & Johnson (JNJ.N), opens new tab said on Monday it had filed a lawsuit against Samsung Bioepis for breaching its contract agreement with the drugmaker over the launch of a biosimilar to Stelara, J&J's autoimmune drug. J&J said it is seeking a preliminary injunction for Samsung Bioepis' close copy of Stelara over an unauthorized sublicense deal with a private label provider, which the drugmaker declined to identify. The company, along with partner Sandoz (SDZ.S), opens new tab, said earlier on Monday that its biosimilar Pyzchiva is now available in the United States. J&J over the past two years has signed settlement agreements with several companies to delay the U.S. launches of Stelara, its top-selling drug since 2019. Close copies of Stelara launched in Europe, Canada and a few other markets last year and at least six close copies of Stelara are expected to launch in the U.S. this year. Teva Pharmaceuticals ( opens new tab and Alvotech (ALVO.O), opens new tab last Friday launched Selarsdi, a biosimilar to Stelara. The U.S. Food and Drug Administration has allowed the use of Selarsdi as an "interchangeable" substitute only after April 30, when the exclusive rights for Amgen's (AMGN.O), opens new tab Wezlana expire. Pyzchiva is approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here.
