Monday, February 24, 2025

Sanofi, Teva Bolster Case for IBD Drug with Phase 2 Data, Despite Potential Competition

(2/24, Ayisha Sharma, Endpoints News) ...Sanofi and Teva's inflammatory bowel disease candidate could make €1 billion ($1.05 billion) a year by 2032, Leerink analysts said on Sunday. The blockbuster projection comes after the partners shared updated Phase 2b data from the anti-TL1A drug, dubbed duvakitug... Full

Enroute to Phase III, Teva and Sanofi Bolster Case for Anti-TL1A Drug

(2/22, Anna Bratulic, FirstWord PHARMA) ...Teva and partner Sanofi presented new detailed results from their Phase IIb RELIEVE UCCD study, demonstrating strong and consistent efficacy for anti-TL1A biologic duvakitug across patient subgroups. The data, shared at the European Crohn's and Colitis Organisation (ECCO) conference on Saturday, set the stage for Phase III testing anticipated to begin in the second half of 2025.... Full

Sanofi and Teva Report New Outcomes from Phase IIb Trial of Duvakitug

(2/24, Clinical Trials Arena) ...The safety data from the study indicated that the therapy was generally "well tolerated" in cohorts of UC and CD, with no new safety signals identified. Sanofi and Teva are partnering on the joint development and commercialisation of the latter's duvakitug for UC and CD treatment, with both companies sharing development expenses and profits in major markets. Sanofi will spearhead the Phase III clinical development while Teva and Sanofi will lead commercialisation efforts in different regions... Full

Teva Launches Stelara Biosimilar at 85% Discount as Wider Field Emerges

(2/21, Zachary Brennan, Endpoints News) ...Teva and its partner Alvotech on Friday followed Amgen in launching a biosimilar to Johnson & Johnson's blockbuster immunosuppressive biologic Stelara, offering a steep discount...Teva launched its Stelara biosimilar on Friday at an 85% discount, a spokesperson confirmed to Endpoints News. Two other Stelara biosimilars are also expected to launch by Monday, including Celltrion's Steqeyma and Biocon's Yesintek at between 86% and 90% off, Bourgoin said... Full

Teva and Alvotech Launch Ustekinumab Biosimilar Injection in US

(2/24, Pharmaceutical Technology) ...This marks the second biosimilar launched in the country through the strategic collaboration between the companies. Selarsdi has been approved by the US Food and Drug Administration in four presentations, aligning with the approved presentations of the reference Stelara... Full

Teva, Alvotech Launch SELARSDI, Stelara Biosimilar

(2/21, Charlie Sternberg, Contract Pharma) ..."Biosimilars like SELARSDI create opportunities for cost savings across the healthcare system, and we are proud to be able to introduce our second biosimilar treatment option in partnership with Alvotech to U.S. patients and providers," said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. "The U.S. availability of SELARSDI reinforces Teva's overall strategy to identify strategic business partners to develop and manufacture biosimilars while leveraging Teva's commercial presence and experience to bring this and other products to the U.S. market."... Full

Second Biosimilar of Stelara Launches

(2/21, Denise Myshko, Managed Healthcare Executive) ...Selarsdi is being offered at 85% off the wholesale acquisition cost of Stelara, and eligible patients may receive their medication at no cost or may be eligible for assistance through Teva's programs, according to a company spokesperson. Teva is in ongoing discussions with payers about Selarsdi, but is unable to disclose details at this time... Full

Samsung Bioepis Launches Stelara Biosimilar in US to Expand Treatment Options

(2/24, Lee Han-soo, Korea Biomedical Review) ...Samsung Bioepis and Sandoz signed a commercialization agreement for Pyzchiva in September 2023 for the U.S. market. While Samsung Bioepis oversees the development, registration, intellectual property, manufacturing, and supply, the license period for Pyzchiva in the U.S. commenced on Feb. 22, 2025, under a settlement and license agreement with Janssen Biotech... Full

Biocon Biologics Launches Yesintek™ (Ustekinumab-kfce) Biosimilar to Stelara® in the United States

(2/24, Biocon Biologics) ...Biocon Biologics Ltd., a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., today announced that YESINTEK™ (ustekinumab-kfce) is now available to patients in the United States, and is one of the first Stelara® (ustekinumab) biosimilar market entrants in the country... Full

Celltrion Secures EU Approval for Actemra Biosimilar

(2/24, Lee Han-soo, Korea Biomedical Review) ...Celltrion said it received marketing authorization from the European Commission (EC) for its biosimilar Avtozma, referencing Actemra (RoActemra in Europe) by Roche. The approval covers major indications of the original drug, including rheumatoid arthritis (RA) and giant cell arteritis (GCA)... Full

German Healthcare Boss Says His Business is Better Bet Than Big Pharma

(2/24, Hannah Kuchler and Florian Müller, Financial Times) ...Stada, which sells generic drugs and consumer health products, is preparing for an IPO in Frankfurt that would be among the largest in European pharma in recent years. According to a person familiar with the company's plans, it could happen as soon as the start of the second quarter. Another person said Stada would aim to raise up to €1.5bn at a valuation of more than €10bn... Sub. Req’d

New Weight-Loss Drugs Like Mounjaro Are Hot Right Now. Eli Lilly's CEO Explains Why They're So Expensive.

(2/21, Theron Mohamed, Business Insider) ...The latest weight-loss drugs including Ozempic, Wegovy, Mounjaro, and Zepbound have list prices ranging from $900 to $1,500 for a one-month supply. David Ricks, the CEO of Mounjaro and Zepbound maker Eli Lilly, explained why these medications are so expensive on the "In Good Company with Nicolai Tangen" podcast this week... Full

Eli Lilly Stockpiles $548M of Oral Weight Loss Drug Ahead of Launch

(2/21, Anna Brown, Endpoints News) ...Eli Lilly has amassed a stockpile of soon-to-be-launched drugs and related materials, primarily its oral GLP-1 candidate orforglipron, worth more than half a billion dollars. Orforglipron will be ready to roll out as soon as it secures regulatory approval, which could come in 2026... Full

Glenmark Pharma Enters Settlement Pact with Humana, Centene, Kaiser for $7 Million, Denies All Allegations

(2/24, Shloka Badkar, CNBC TV-18) ...Glenmark Pharma on Monday, February 24, denied the allegations of the multiple lawsuits against the company and its US subsidiary, but said it has agreed to settle the matter with the plaintiffs — Humana, Centene, Kaiser —for a total of $7 million. It said there were multiple antitrust and consumer protection lawsuits, including a class action, consolidated in Virginia, US, against the company and its subsidiary Glenmark Pharma Inc, USA in relation generic Zetia, which is a drug for the treatment of cholesterol... Full

Drugmaker Amgen to Invest $200 Million in India Site, CEO Says

(2/24, Rishika Sadam, Reuters) ...U.S. drugmaker Amgen will invest about $200 million this year in its new technology centre in southern India, with further investments planned, CEO Robert Bradway said at the inauguration of the site on Monday. Amgen announced its plans to open a "technology and innovation" site in India last year that is focused on increasing the use of AI and data science to support development of new medicines... Full

MS Patients Suffer Side-Effects After NHS England Switches to Cheaper Drug

(2/24, Denis Campbell, The Guardian) ...About 170 MS patients at Charing Cross hospital in London have had complications, including a relapse of their illness, after being switched from Tysabri to a different drug called Tyruko, made by the pharmaceutical company Sandoz. In a handful of cases, the people affected developed such serious symptoms that they had to be taken to hospital for treatment... Full

Investigators Find Repurposing Amlodipine as Novel Treatment for ADHD

(2/22, Ashley Gallagher, Drug Topics) ...Repurposing amlodipine, a medication commonly used for blood pressure, shows potential as a novel treatment for attention-deficient/hyperactivity disorder (ADHD), according to the results of a study published in Neuropsychopharmacology. Investigators of the study aimed to determine if 5 potential drugs could reduce ADHD symptoms in rats... Full

Trump Told Drugmakers to Move Production to US or Face Tariffs

(2/21, Rachel Cohrs Zhang, Damian Garde and Skylar Woodhouse, Bloomberg) ...President Donald Trump warned drugmakers in a private meeting that tariffs are coming and said companies should hustle to move overseas manufacturing to the US, according to two people familiar with the conversation. Trump also didn't commit to pushing Congress to water down a drug pricing program enacted under President Joe Biden that the pharmaceutical industry has been seeking relief from... Sub. Req’d

Post-Hoc: Pharma CEOs' Alternative Reality with Trump

(2/22, Andrew Dunn, Endpoints News) ...The CEOs may view their recent meeting at the White House as evidence of success. The price of admission, though, seems to be the industry's most powerful leaders biting their tongues on defending some basic scientific principles, like vaccine safety, and institutions, like the NIH... Full

Trump Admin Defends IRA Drug Price Negotiation Program in Novartis Lawsuit

(2/24, Noah Tong, Fierce Healthcare) ...In a filing Feb. 19, the government agreed with the legal arguments used by the prior administration and by a lower court, dealing a blow to pharmaceutical drugmakers enraged by the program. The Trump administration claimed the "district court correctly concluded that it lacked jurisdiction to review plaintiff's Eighth Amendment claim," as well as "correctly rejected" takings and compelled speech claims. The defendants claim the program is consistent with the First Amendment... Full

PhRMA Kicks Off Year Attacking China, Wrapping Agenda In American Flag

(2/21, Sarah Karlin-Smith, Pink Sheet) ...The PhRMA lobby argues the Trump administration must fulfill the drug industry's policy asks to remain ahead of China. The trade group's agenda includes ending government price negotiation and changing mergers and acquisitions and intellectual property policies. The industry must be careful painting China as the enemy because it also has important business interests in the country... Global Sub. Full

PhRMA Pledges To Boost U.S. Manufacturing, Lower Patient Costs Amid Tussle Over Tariffs

(2/21, Maaisha Osman, Inside Health Policy) ...When asked about the meeting, Alex Schriver, senior vice president of public affairs at PhRMA, told Inside Health Policy in a statement, "PhRMA President & CEO Steve Ubl and members of our board had a productive conversation with President Trump today. We expressed our commitment to strengthening American leadership in biopharmaceutical innovation, revitalizing domestic manufacturing, and lowering costs for patients."... Sub. Req’d

In the Age of Economic Warfare, the US Drug Supply Is a Weak Link

(2/23, Edward Fishman, The Boston Globe) ...Last year, US imports of pharmaceuticals surged to over $200 billion — putting them on pace to overtake cars as our top imported consumer good. Many of the high-priced branded drugs that Americans rely on are made either in Europe or domestically. But roughly 80 percent of all generic drugs — the backbone of the American health care system, accounting for 9 in every 10 prescriptions — are produced overseas, with China playing an outsized role... Full

Novo's Wegovy and Ozempic Removed from US FDA Shortage List, Compounders On Notice

(2/21, Patrick Wingrove, Bhanvi Satija, Reuters) ...The U.S. Food and Drug Administration said on Friday there was no longer a shortage of Novo Nordisk's popular weight-loss and diabetes drugs, Wegovy and Ozempic, a declaration that will curtail widespread sales of cheaper copies made by compounding pharmacies...The FDA said in a statement that compounding pharmacies would be given a grace period of 60 to 90 days, as was the case when Lilly's drugs were declared out of shortage... Full

Trump Administration Rehires Some FDA Employees it Fired

(2/23, Lizzy Laawrence, STAT+) ...The total number of employees rehired is unclear, but in at least some cases the reinstatements appeared to be broad. All 12 of the people who worked in the office reviewing surgical and infection control devices were reinstated, an agency source said. Two of three people in the FDA's digital health office who had been let go were rehired, as were a handful of employees reviewing AI-enabled imaging devices, diabetes devices and cardiovascular devices, according to four other agency sources... Sub. Req’d

Maryland Lawmakers Vote to Expand Powers of the State's Prescription Drug Affordability Board

(2/21, Ed Silverman, STAT+) ...The Maryland House of Delegates has voted overwhelmingly to allow a state board to extend its mandate for lowering prescription drug costs to all residents, not just those employed by government agencies. As a result, the initiative now goes to the state Senate for approval, although the timing is unclear... Sub. Req’d

EU Bets On Pharma Package Amid Trump Tariff Threats

(2/24, Thomas Mangin, Euractiv) ...The German statistics institute Statista mentioned in a report that revenue within the EU could reach €196.5 billion by 2025, but the cards have been reshuffled since Donald Trump's return to the White House, who is relying on tariffs to push companies to set up operations in the United States. "It's certain that if we face a trade war, it will have a significant impact. Tariffs really hurt the industry. But with the Pharma Package, we have commitments to the industry," a diplomatic source told Euractiv... Full

Richard Curran: Ireland's Multi-Billion Pharma Industry is Now Firmly in the Firing Line of Trump Tariffs

(2/22, Richard Curran, Irish Independent) ...IDA Ireland chief executive Michael Lohan gave some comfort during the week when he suggested the industry here might avoid some tariffs because it isn't always a finished product they are sending to the US. This could be a clever get-outclause or simply clutching at straws. If most of the value in making the product happens here and it is simply bottled and packaged in the US, this could be a tricky argument to make... Sub. Req’d

The Cheap Medicine Drive That Could Erode Trust in China's Healthcare System

(2/23, Phoebe Zhang, South China Morning Post) ...In a bid to cut state spending on healthcare, Chinese authorities have been bulk buying medicines for use in public hospitals and lowering prices through negotiations and bids. But in recent months, there has been public anger over concerns that the cheaper generic drugs which replaced the original brand-name medicines in public hospitals and the national insurance scheme are ineffective... Full

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