Tuesday, February 25, 2025

Sanofi, Teva Add to Case for New Bowel Disease Drug

(2/24, Ned Pagliarulo, BioPharma Dive) ...Detailed trial results could help Sanofi and Teva Pharmaceuticals make a case that a drug they've been developing will be competitive with rival treatments from Merck & Co. and Roche. The data, presented over the weekend at a medical conference in Berlin, show the drug led to higher rates of clinical response, remission and improvement on endoscopic imaging than placebo among participants with either Crohn's disease or ulcerative colitis... Full

Sanofi Shows How $500M Bowel Disease Bet Compares to Merck and Roche's Rival Assets

(2/24, Nick Paul Taylor, Fierce Biotech) ...Sanofi and Teva's 27% placebo-adjusted rate of endoscopic improvement falls in the middle of the rivals' range. Roivant, the source of Roche's TL1A prospect, reported a 21% delta compared to placebo after 12 weeks. Prometheus Biosciences, which Merck acquired, saw a 31% placebo-adjusted rate of endoscopic improvement at Week 12 of its phase 2 ulcerative colitis trial. The new duvakitug data also clear up the question of whether the hit on the primary endpoint of clinical remission was driven by subgroup performance... Full

More Stelara Rivals Hit US, With Discounts Already Reaching 85%

(2/24, Dave Wallace, Generics Bulletin) ...Confirming media reports, Teva told Generics Bulletin that while "pricing may vary", it was introducing Selarsdi at an 85% discount to Stelara's wholesale acquisition cost. "Teva is committed to helping patients gain affordable access to our medicines," a spokesperson told Generics Bulletin...And commenting on the general market landscape, Teva told Generics Bulletin that it was "committed to expanding the availability, access, and uptake of biosimilars in the US," indicating that "the biosimilars market in the US is evolving and is a marathon, not a sprint."... Global Sub. Full

Ustekinumab Biosimilars Pyzchiva, Selarsdi, and Yesintek Now Available

(2/24, Diana Ernst, Rph, MPR) ...Pyzchiva® (ustekinumab-ttwe; Sandoz), Selarsdi™ (ustekinumab-aekn; Teva and Alvotech), and Yesintek™ (ustekinumab-kfce; Biocon Biologics), all biosimilars to Stelara® (ustekinumab; Johnson & Johnson) are now available in the US... Full

3 Ustekinumab Biosimilars Launch On US Market

(2/24, Skylar Jeremias, The Center For Biosimilars) ...After Wezlana (ustekinumab-auub) became the first ustekinumab biosimilar to enter the market in January 2025, others joined the fray, expanding access to lower-cost versions of blockbuster Stelara (ustekinumab). Samsung Bioepis/Sandoz, Biocon Biologics, and Teva/Alvotech launched their respective ustekinumab products: Pyzchiva (ustekinumab-ttwe), Yesintek (ustekinumab-kfce), and Selarsdi (ustekinumab-aekn)... Full

Formycon Receives Regulatory Approval in the UK for FYB203 (Aflibercept), A Biosimilar to Eylea®, Under the Brand Name AHZANTIVE®

(2/25, Formycon AG) ..."With the approval of FYB203, our second ophthalmic biosimilar in the UK, we take yet another significant step in making essential ophthalmic therapies more widely available," said Dr. Stefan Glombitza, CEO of Formycon AG. "In addition to Ongavia®3, our successful ranibizumab biosimilar in the UK, --AHZANTIVE® will provide a new, cost-efficient treatment option for patients with severe retinal diseases, through our strong commercial partner Teva." The U.S. Food and Drug Administration (FDA) had already granted marketing authorization for FYB203 in June 2024, followed by European Commission`s approval in January 2025... Full

Updated: Two More Stelara Biosimilars Launch, Including One That is 90% Off Stelara

(2/24, Denise Myshko, Formulary Watch) ...Sandoz and Biocon Biologics have each launched their biosimilar versions of Johnson & Johnson's Stelara (ustekinumab)...Two additional Stelara biosimilars have already launched. Last week, Teva and Alvotech it's biosimilar Selarsdi (ustekinumab-aekn) at an 85% discount off Stelara, and eligible patients may receive their medication at no cost or may be eligible for assistance through Teva's programs Selarsdi, approved by the FDA in October 2024, is available as a single-dose prefilled syringe for subcutaneous injection and in a single-dose vial for intravenous infusion... Full

J&J Sues Samsung Bioepis Over Contract Breach for Stelara Biosimilar

(2/25, Sneha S K, 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...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... Full

Eli Lilly, Novo Nordisk Lead Revenue Boom in the 'Always Tricky' Q4

(2/24, Kevin Dunleavy, Fierce Pharma) ...Revenues in the biopharma industry continued to boom in the fourth quarter of last year, following a pattern seen increasingly throughout 2024. Of the world's 22 biopharma companies that had reported quarterly revenue of at least $2 billion by Feb. 24, only one posted a year-over-year decline... Full

Celltrion's 2024 Revenue Hits Record High On Blockbuster Drug Growth, Portfolio Expansion

(2/25, Lee Han-soo, Korea Biomedical Review) ...Celltrion achieved a record-high annual revenue of 3.56 trillion won ($2.48 billion) in 2024, up 63.5 percent from the previous year. The sales growth was fueled by the strong performance of its blockbuster biologics, increasing sales in key global markets, and the expansion of its biosimilar portfolio... Full

Glenmark Eyes Generic Flovent Launch In Coming Months Amid Expected US Resurgence

(2/24, Dean Rudge, Generics Bulletin) ...Glenmark expects an uptick in its key North America business beginning in the firm's 2025/26 financial year onwards, on the back of potential launches in the respiratory and injectable segments, including the closely-watched potential launch of its generic version of GlaxoSmithKline's Flovent (fluticasone propionate) pressurized metered-dose inhaler... Global Sub. Full

Fresh Off FDA Approval, Axsome's Migraine Med Proves Mettle Against CGRPs

(2/24, Elizabeth S. Eaton, FirstWord PHARMA) ...Looking to carve out a niche for its newly approved migraine treatment, Axsome Therapeutics shared data Monday demonstrating that Symbravo (meloxicam/rizatriptan) can help patients who don't respond to oral CGRP inhibitors. The oral drug won FDA approval in January for the acute treatment of migraine with or without aura in adults, nearly three years after an initial rejection from the US regulator... Full

Lilly Launches Higher Dose Vials of Weight-Loss Drug for $150 Less Than Injector Pen

(2/25, Patrick Wingrove, Reuters) ...li Lilly said on Tuesday it has begun selling higher doses of its popular weight-loss drug Zepbound in vials in the U.S. at a $150 discount to the cost of the injector pen versions, as it seeks to spur further demand for the medicine. The drugmaker said patients could purchase 7.5 milligram and 10mg vials of Zepbound for $499 a month on the LillyDirect website. That is nearly 23% less than the $650 Lilly charges for auto-injectors of the drug to patients who are insured but not covered for the medicine... Full

Pfizer Hires Ex-FDA Drug Chief as Top Doctor

(2/24, Nathaniel Weixel, The Hill) ...The former head of the Food and Drug Administration's (FDA) drug division is joining Pfizer as its chief medical officer, the company announced Monday...The announcement spurred renewed criticisms about the common "revolving door" between the FDA and industry. Critics worry the close relationship leads to a quid pro quo and favoritism toward industry... Full

Adderall Shortage Continues to Impact Millions of Americans Living with ADHD

(2/24, Ali Hickerson, KIRO7) ...These delays have been attributed to supply chain and manufacturing issues, high prescription rates spurred by the growth in telemedicine, and limited production quotas. As many as 15.5 million adults and 7 million children navigate life with ADHD and are affected by these shortfalls daily. ADHD Advisor examined data from the Drug Enforcement Administration and other sources to explore the rise in prescription stimulants and why this shortage is so concerning... Full

What Do Consumers Really Think About Generics?

(2/24, Sandra Levy, Drug Store News) ...Nearly two in three Americans (63%) choose generic medications over brand-name options. This finding comes from a new report from Tebra, which surveyed more than 1,000 Americans and compared the costs of popular medications in five major U.S. cities... Full

CivicaScript® Lowers Price of its Generic Abiraterone Tablets

(2/24, CivicaScript) ...CivicaScript,® a nonprofit company dedicated to bringing low-cost generic medicines to U.S. consumers, announced today that it has lowered the price of its lead product, Abiraterone Acetate Tablets, USP 250 mg... Full

Trump Says Canada, Mexico Tariffs On Schedule Despite Border, Fentanyl Efforts

(2/24, David Lawder, Andrea Shalal, Reuters) ...President Donald Trump said on Monday that tariffs on Canadian and Mexican imports are "on time and on schedule" despite efforts by the countries to beef up border security and halt the flow of fentanyl into the U.S. ahead of a March 4 deadline... Full

Indian Drugmakers Likely to Stay Competitive as US Tariffs Loom, Dr Reddy's Says

(2/25, Rishika Sadam, Reuters) ...Indian drugmakers are likely to remain competitive in the generics market even as U.S. President Donald Trump's plans to levy tariffs on pharmaceutical imports, Dr Reddy's Managing Director GV Prasad said on Tuesday...India's drug industry has pinned its hopes on bilateral talks to earn an exception, though Trump has ruled out any such concession so far... Full

Trump Administered 25% Tariff Threat On Pharmaceutical Imports Force India's Pharma Sector to Look Beyond the U.S.

(2/25, Lalatendu Mishra, The Hindu) ...Its time for Indian pharma companies to look beyond the U.S. market as the Trump administration has threatened to impose 25% tariff on pharmaceutical imports. This move would disrupt India's dominant position in the U.S. market, where it supplies over 45% of its generic medicines, industry officials said. As of 2023, the size of India's pharmaceutical sector was estimated at about $55 billion, and the global export pie was worth $27 billion. As per a report by Bain & Company market is projected to touch $130 billion by 2030 and $450 billion by 2047. It is feared that going forward Pharma exports to the US would shrink as the higher tariff would make Indian drugs expensive... Full

House Energy & Commerce To Markup Oversight Agenda

(2/24, Amy Lotven, Inside Health Policy) ...The full House Energy & Commerce Committee will meet Tuesday (Feb. 25) to mark up its oversight agenda for the 119th Congress, which will focus on cutting waste, fraud, and abuse in federal health care programs, probing the impact of chronic disease, monitoring implementation of the Medicare drug negotiation program and Part D design, examining National Institutes of Health (NIH) grantmaking policies, ensuring FDA regulation is adequate and more... Sub. Req’d

BCBSA Report: Addressing Hospital, Pharma Costs Could Save $1T Over Next Decade

(2/25, Paige Minemyer, Fierce Healthcare) ...The federal government under the Trump administration has turned its focus to cutting costs, and a new report from the Blue Cross Blue Shield Association (BCBSA) highlights policy efforts it says could save nearly $1 trillion in healthcare costs over the next decade. The road map includes 10 policy proposals for stakeholders to consider, and BCBSA said these changes could drive federal savings of $524 billion, lower private insurance premiums by $389 billion and save patients $180 billion out-of-pocket... Full

Drug Compounders Sue US FDA Over Removal of Wegovy, Ozempic from Shortage List

(2/24, Brendan Pierson, Reuters) ...Drug compounders sued the U.S. Food and Drug Administration on Monday over its decision last week to remove Novo Nordisk's weight-loss and diabetes treatments Wegovy and Ozempic from its shortage list, a move that will sharply curtail the ability of compounders to sell cheaper versions of the medicines... Full

Exclusive Interview: Califf Talks Trump Admin's Impact On FDA

(2/24, Jessica Karins, Inside Health Policy) ...Former FDA commissioner Robert Califf said his message to staff at his former agency is that they should follow the law and stick to ethical principles amid a wave of layoffs he called "inhuman" and potentially major changes to policy, and that he has hope the agency will eventually bounce back stronger. "I would say it's going to be a hard time at the FDA, and it'll take a lot of resiliency for good people for stand up for what's right," Califf told Inside Health Policy in an interview Wednesday (Feb. 19)... Sub. Req’d

In Letter to RFK Jr., Democrats Flag Threats to Drug Review Process from FDA Firings

(2/24, Zoey Becker, Fierce Pharma) ...Sens. Jeanne Shaheen and Patty Murray, plus Reps. Sanford Bishop and Rosa DeLauro, wrote to RFK Jr. on Friday with "grave concerns" about mass firings of probationary staff at the FDA. They cited cuts in the agency's Center for Devices and Radiological Health, the Center for Tobacco Products (CTP) and the Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), specifically... Full

DOGE-ing US FDA: Three Scenarios For What Comes Next

(2/24, Michael McCaughan and Ramsey Baghdadi, Pink Sheet) ...President Trump's executive order requiring federal government restructuring offers several potential scenarios for FDA restructuring. User fee-supported essential employees could be retained, but another option could be combining the drug and biologics centers into a single review staff. A third option would spar the FDA from a reduction in force entirely, except through natural attrition... Global Sub. Full

King Works to Give Maine People Access to Lower-Cost Prescription Drugs from Canada

(2/24, U.S. Senator Angus King) ...U.S. Senator Angus King (I-ME) is cosponsoring bipartisan legislation that would allow Americans to save money by importing the same medications from pharmacies in Canada — for less. The Safe and Affordable Drugs from Canada Act would give Americans safe access to prescription drugs from Canada, which would help lower costs, increase access for consumers and positively impact the domestic market for consumers through increased competition... Full

NHS And Sandoz Look Into Natalizumab Switching Reports

(2/24, Dave Wallace, Generics Bulletin) ...The UK's NHS and Sandoz have both told Generics Bulletin that they are looking into reports from a single UK hospital of adverse reactions linked to patients that have switched from Tysabri to Sandoz's Tyruko biosimilar... Global Sub. Full

Turn Trump's Pharma Protectionism into EU Resilience Opportunity, Says Greek MEP

(2/24, Vasiliki Angouridi, Euractiv) ...The Trump administration's increased tariff strategy could impact the EU's resilience by disrupting trade and raising costs. Still, the tariffs could create opportunities for greater EU strategic autonomy, Greek MEP (S&D) Nikos Papandreou told Euractiv in a recent interview. Washington's efforts to repatriate pharmaceutical production have raised concerns about the impact this will likely have on the EU's resilience and competitiveness... Full

Cross-Atlantic Alliance Sets Sights On First HTA Methods Recommendations

(2/24, Francesca Bruce, Pink Sheet) ...HEMA, a new collaboration on health technology appraisal dedicated to reviewing and assessing new methods and processes used in HTAs, is gathering pace and is set to identify its first topic for targeted recommendations at the end of February...The pharmaceutical industry will play an advisory role with seats on HEMA's steering committee. It will offer insight into which topics the working group should develop into white papers and recommendations... Global Sub. Full

Drug Reimbursement Costs Down in Denmark

(2/24, The Pharma Letter) ...After a significant increase in 2023, Danish regions' expenses for subsidized medicines fell by 4.3% in 2024. The decrease is due to factors including increased security of supply, an industry price cap agreement, patent expiries and a reassessment of the reimbursement status of certain medicines, according to Lif, Denmark's life sciences association... Sub. Req’d

Opioid Drugs Row: Health Secretary Calls for Stronger Regulations to Ensure Quality Medicines

(2/25, Financial Express) ...Chairing a meeting with state drug regulators to address illicit use of psychotropic drugs under the Nasha Mukt Bharat Abhiyan and strengthen regulatory capacities of states and UTs on Monday, she said regulatory standards need to be strong to ensure that only quality and effective medicines circulate in the country. During the meeting, Srivastava urged state drug regulators to ensure that medicines are sold only through prescriptions so that narcotic drugs are not diverted for trafficking or other illicit uses... Full

Not Business As Usual: On Upholding India's Reputation for Quality Drugs

(2/25, The Hindu) ...A BBC Eye investigation has brought to light the criminal actions of Aveo Pharmaceuticals, a Maharashtra-based company, which was manufacturing and exporting unapproved, highly addictive opioid drug combinations to West Africa. The "medicines" contain tapentadol, a powerful opioid, and carisoprodol, a highly addictive muscle relaxant. While the Indian drug regulator has approved tapentadol and carisoprodol as standalone drugs, the combination has no clearance... Full

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