Latest news with #Pyzchiva
Korea Herald
09-06-2025
- Business
- Korea Herald
Samsung Bioepis partners with Nipro for Japan market entry
Samsung Bioepis, the biosimilar unit of Samsung Group, announced Monday that it has signed a commercialization agreement with Japan-based pharmaceutical and medical device company Nipro to enter the Japanese market. The deal covers the licensing, development and commercialization of multiple biosimilars, including SB17, a biosimilar referencing Stelara (ustekinumab), used to treat autoimmune conditions. This marks the company's first partnership with a Japanese pharmaceutical company. Under the agreement, Samsung Bioepis will oversee development, manufacturing and supply, while Nipro will manage sales and distribution in Japan. 'The partnership is a major milestone for our entry into Japan,' said Samsung Bioepis CEO Kim Kyung-ah. 'We aim to enhance patient access to high-quality biopharmaceuticals through close collaboration with local partners.' SB17 is a biosimilar to Janssen's Stelara, which treats inflammatory diseases such as psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. Samsung Bioepis launched its proprietary Stelara biosimilar, Pyzchiva, in the US earlier this year, followed by an increased market competition after Stelara's US patent expiry in 2023. After receiving approval in Europe last year, Pyzchiva went on to secure a 43 percent market share, emerging as a leading product in the region's biosimilar market. Founded in 2012, Samsung Bioepis has gained approval for 11 blockbuster biosimilar products and posted 1.54 trillion won ($1.13 billion) in revenue in 2024. Meanwhile, Samsung Bioepis is scheduled to separate from its parent company, Samsung Biologics, in October to operate as a new holding company, a strategic move aimed at easing client concerns over potential conflicts of interest between Samsung Biologics' contract development and manufacturing business and Samsung Bioepis' biosimilar unit.
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.
