Polpharma SA

More than two years after securing FDA approval, Sandoz has launched Tyruko (natalizumab-sztn) in the US, making it the first biosimilar version of Biogen's multiple sclerosis (MS) treatment Tysabri (natalizumab) to hit the North American market.  Approved in August 2023, Tyruko had been set to launch in the US the following year, subject to FDA approval of a test for anti-JCV antibodies. However, delays in authorisation of the assay led to delays in Tyruko — seen as a key growth driver for Sandoz — hitting the US market. The company said Monday that it has partnered with Labcorp to develop and validate a laboratory-developed test for detecting the presence of anti-JCV antibodies, a major risk factor for progressive multifocal leukoencephalopathy. This test will be offered by Labcorp free of charge to eligible patients, with Sandoz covering the cost of the test. "As the only biosimilar available to treat multiple sclerosis in the US, Tyruko has an important opportunity to help people with MS navigate this disease in a way that is more cost effective," remarked Keren Haruvi, president of Sandoz North America. Tyruko is approved in the US for the same indications as Tysabri, which is cleared as a monotherapy for relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease, as well as Crohn's disease in adults. Tysabri — an anti-α4 integrin monoclonal antibody disease modifying treatment — generated sales of $1.7 billion in 2024.  Sandoz gained rights to Tyruko as part of an agreement with Polpharma in 2019, under which the latter is responsible for development, manufacturing and supply of the therapy's active substance, with the former commercialising and distributing it in all markets. Tyruko was approved in the EU in 2023 and has so far been launched in 14 countries.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Johnson & Johnson was handed a complete response letter for a potential label expansion of Darzalex Faspro over issues found after a facility inspection, the company said Friday. Darzalex Faspro is being reviewed in a quadruplet regimen in newly diagnosed, transplant-ineligible multiple myeloma. No safety or efficacy concerns were raised and no new clinical data are needed. Charles River Laboratories said during its second-quarter earnings call Wednesday that overall demand from its pharma clients appears to be stabilizing, but smaller biotechs are still constrained over a lack of funding. The company is not yet seeing any “meaningful impact on client spending patterns” due to tariffs or drug pricing issues, CEO James Foster said. Charles River has been slightly affected by NIH funding cuts, but this only a “small impact,” Foster added. Overall, the company reported a revenue of $1.03 billion for Q2, up 0.6% from the $1.02 billion reported in the same period last year. CDMO Esteve is acquiring Chicago-headquartered CDMO Regis Technologies, in a move that would see it expand to the US for the first time, the company said July 31. This deal expands Esteve’s services to include manufacturing of small molecule APIs for preclinical to commercial purposes. Indian API maker Garonit Pharmaceutical is building a $46.1 million facility in New Windsor, Orange County, according to a Monday release. The 200,00-square-meter site will manufacture antiseptic products. New York State is investing $3.8 million to aid the project. Bora Pharmaceuticals is expanding its facility in Maple Grove, MN, the company said Tuesday. The first step of the expansion is to be operational in Q3. Fresenius Kabi and Polpharma Biologics have entered into a new licensing agreement, according to a Tuesday release. Fresenius Kabi will exclusively commercialize Polpharma’s biosimilar to the biologic vedolizumab, sold by Takeda under the brand name Entyvio, which is used to treat Crohn’s disease and ulcerative colitis. API maker Axplora is investing €6.5 million to expand a site in India, the company said Tuesday.

Fresenius Kabi will have exclusive commercialisation rights globally, excluding the Middle East and North Africa. Credit: JHVEPhoto / Shutterstock.com. Fresenius Kabi has entered a global licensing agreement for the commercialisation of Polpharma Biologics’s vedolizumab biosimilar candidate PB016, except in the Middle East and North Africa. An integrin receptor antagonist, Vedolizumab is a biologic therapy indicated for the treatment of ulcerative colitis and Crohn’s disease. Under this agreement, Polpharma Biologics will lead the development and manufacturing of PB016 while Fresenius Kabi will have exclusive commercialisation rights globally, excluding the Middle East and North Africa. Polpharma Biologics’s PB016 is a proposed biosimilar candidate referencing Takeda’s Entyvio, which is used to treat moderately to severely active ulcerative colitis and Crohn’s disease. Polpharma Biologics group supervisory board member Konstantin Matentzoglu said: “This partnership reinforces our mission to broaden access to high-quality biologics that improve patient outcomes globally.” Matentzoglu further highlighted Fresenius Kabi’s expertise, saying: “Fresenius Kabi’s deep commercialisation experience and commitment to biosimilars make them an ideal partner for bringing PB016 to patients worldwide. Together, we are taking an important step toward addressing the rising burden of chronic inflammatory diseases.” GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Fresenius Kabi biopharma president Dr Sang-Jin Pak said: “The in-licensing of PB016 from Polpharma Biologics underscores our commitment to expanding our autoimmune biosimilars portfolio and addressing the unmet needs of patients with chronic inflammatory diseases.” The deal is stated to build on Polpharma Biologics’ growing biosimilar portfolio. It has previously brought forward several biosimilars, such as ranibizumab and natalizumab, in collaboration with pharmaceutical entities across global markets. This strategic alliance aims to enhance global access to affordable biologic medicines and support healthcare system sustainability. The partnership aligns with both companies’ commitments to expanding the availability of biologics worldwide. Last October, Fresenius Kabi and Cellular Origins formed a partnership to advance the field of cell and gene therapy (CGT) by automating the manufacturing process. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now