Tuesday, March 25, 2025

‘Our Commitment Is Serious': Fresenius Kabi's CEO Pierluigi Antonelli On Biosimilars And Beyond

(3/24, Generics Bulletin) ...Fresenius Kabi is drawing closer to the conclusion of its Vision 2026 strategic roadmap. The company's CEO, Pierluigi Antonelli, talks to Generics Bulletin about the company's results so far and how it's investments in biosimilars, acquisitions and manufacturing is paying off... Global Sub. Full

Axsome Therapeutics' ADHD Drug Meets Main Goal in Late-Stage Study

(3/25, Mariam Sunny, Reuters) ...The drug, solriamfetol, helped ease symptoms which include difficulty paying attention, restlessness, and impulsivity in adults as measured using a common scale, the company said. The drug was found to be safe and well tolerated in the study with no serious side-effects, Axsome said. The company plans to begin a trial in pediatric patients this year... Full

Celltrion's Stelara Biosimilar Wins Costco Formulary Listing

(3/25, Kim Ji-hye, Korea Biomedical Review) ...Celltrion's autoimmune disease treatment Steqeyma (ustekinumab) is set to be sold at Costco pharmacies across the U.S. under a new listing agreement with Costco Health Solutions, the pharmacy benefit manager (PBM) arm of the retailer... Full

Novo Nordisk Expands Discounted Wegovy to All Cash-Paying US Customers

(3/24, Bhanvi Satija and Sriparna Roy, Reuters) ...Novo Nordisk said on Monday all eligible cash-paying customers in the United States can buy its weight-loss drug Wegovy at a discounted price of $499 per month at their local pharmacy. U.S.-listed shares of Novo fell more than 2.5% to $74.92 in premarket trading. Novo has also lost its spot as Europe's largest company to German software firm SAP having underperformed the market in recent months... Full

Hypera Lines Up Brazilian Semaglutide Launch Next Year

(3/24, Dave Wallace, Generics Bulletin) ...Brazil's Hypera does not intend to be left out of the race to compete with Ozempic (semaglutide) when generic rivals launch in its domestic market next year. Speaking during the firm's full-year results call, CEO Breno Oliveira has set out the company's plans to launch its own generic semaglutide, as well as offering expectations around pricing dynamics for the product... Global Sub. Full

Merck Strikes Deal for Heart Drug, Worth Up to $2B, With China's Hengrui

(3/25, Drew Armstrong, Endpoints News) ...Under the deal, Merck will get all non-China rights to Hengrui's drug HRS-5346, a small molecule lipoprotein(a) inhibitor. It will pay $200 million upfront and as much as $1.77 billion in milestone payments, plus royalties...Drugmakers see it as a major new market in cardiovascular care, estimating that more than a billion people around the globe have elevated Lp(a) levels. Dean Li, president of Merck Research Laboratories, called the molecule "an important addition that expands and complements our cardio-metabolic pipeline."... Full

Two Biotechs Fail to Beat or Match Regeneron's Eylea in Key Trials

(3/24, Lei Lei Wu, Endpoints News) ...Opthea and Unity Biotechnology, which are both developing new drugs for eye diseases, were unable to beat or match aflibercept, the standard-of-care treatment that Regeneron markets as Eylea, in two different conditions. Opthea said Monday that its VEGF drug sozinibercept in combination with Eylea failed a Phase 3 study in wet age-related macular degeneration, an eye disease that causes blurry central vision... Full

Sandoz, Boehringer Deal May Unlock Generic Competition for Ofev

(3/24, Christopher Yasiejko, Bloomberg Law) ...Sandoz Inc. and Boehringer Ingelheim International GmbH agreed to a federal court judgment that Sandoz's proposed copies of Ofev don't infringe two patents for the rare-lung-disease treatment, potentially accelerating competition by allowing Sandoz to leapfrog other generics... Sub. Req’d

Wells Fargo Wins Dismissal of Suit Over Prescription Drug Costs

(3/24, Lauren Clason, Bloomberg Law) ...A group of former Wells Fargo employees failed to prove the bank neglected its fiduciary duties over its health plan's prescription drug costs because they could not prove concrete harm, a federal judge in Minnesota ruled Monday... Sub. Req’d

GLP-1s Boost Pharma R&D Projected Return On Investment: Deloitte

(3/25, Anjalee Khemlani, Yahoo! Finance) ...Popular diabetes and weight-loss drugs known as GLP-1s are helping to boost the biopharma sector's return on investment this year, according to a new report from consulting firm Deloitte...The report suggests that pharma companies should focus on finding areas of unmet need. The companies should also think more boldly about new technologies and platforms to invest in, which could result in a similar ROI as the GLP-1s, based on total cost rather than a similar large market size. In other words, what the industry is already pivoting to: more novel new therapies with high price tags... Full

Spending Growth On GLP-1s Outpaces Specialty Drugs: Evernorth Study

(3/25, Paige Minemyer, Fierce Healthcare) ...Pharmaceutical spending overall has grown significantly in recent years, but it has accelerated since semaglutide earned approval for chronic weight management in 2021. Afterward, the rate of annual growth rose from 2.1% in 2021 to 12.8% in 2024, according to the report. Specialty pharmacy has traditionally been the key source of growth in pharmacy spend. For comparison, in 2019, spending for traditional medications decreased by 5% while spending on specialty drugs grew by 11.5%... Full

Closed Loop Medicine to Enter the GLP-1 Arena Following US Patent Portfolio Expansion

(3/24, Marta Rybczynski, FirstWord PHARMA) ...CEO Hakim Yadi told FirstWord that "any GLP-1 pharma company moving towards precision dosing, irrespective of whether they plan to do this in conjunction with a digital strategy, would likely need to take a licence to CLM's IP," adding that, "at the very least, they would need to invest significantly to navigate around it, making CLM's IP portfolio an extremely valuable asset and an attractive target for partnering."... Full

Trump Auto Tariffs Are Coming, But Not All Levies Will Be Imposed April 2, Sending Stocks Higher

(3/24, Andrea Shalal, David Lawder and Timothy Gardner, Reuters) ...A White House official declined to say exactly when sector-specific tariffs on autos, pharmaceuticals or semiconductor chips would come into effect, noting that was still "TBD (to be determined) and at the president's discretion."..."We've been ripped off by every country," Trump said after a meeting of his cabinet, predicting that the expected tariffs would raise "rather astronomical" amounts of money for U.S. coffers, allowing tax rates to remain low or come down. Trump, who has said countries can still avoid levies if they lower their tariffs or move manufacturing to the U.S... Full

Three Major Questions On Pharma Tariffs Trump Claims Are On The Way

(3/24, Max Bayer, Endpoints News) ...President Donald Trump reiterated his plans to "at some point" put tariffs on pharmaceutical goods made outside the US, taking another step toward a trade policy that the industry has been trying to avoid. "We don't make pharmaceuticals anymore in our country," he said at a Monday cabinet meeting. "And if we have problems like wars or anything else, we need steel, we need pharmaceuticals, we need aluminum, we need a lot of these things that we sort of don't make anymore."... Full

Medicare $2 Drug List Model Could Have Reduced 2021 Out-of-Pocket Generic Costs

(3/24, Brooke McCormick, AJMC) ...The researchers identified 381 million claims for the 101 generic drugs filled by 30.7 million eligible Part D beneficiaries in 2021. They found that the mean (median) per-claim out-of-pocket spending was $5.30 ($2.10), but this would have dropped to $2.00 ($2.00) under the Medicare $2 drug list model... Full

Study Shows ‘Insurer-PBMs' Dominate Medicare Part D, Steer Patients to Their Pharmacies

(3/24, Jinghong Chen, Pink Sheet) ...The researchers analyzed a 20% sample of Medicare Part D claims data from Medicare Advantage Prescription Drug (MA-PD) plans and stand-alone Prescription Drug Plans (PDPs) for 2021, which collectively covered more than 10.4 million beneficiaries. They found 34.1% of all pharmacy spending, 37.1% of specialty pharmacy spending, and 32.1% of non-specialty pharmacy spending occurred through pharmacies owned by The Cigna Group, CVS Health Corp., Humana Inc., or UnitedHealth Group... Global Sub. Full

Biosimilars Forum Chair of Scientific Affairs Committee to Speak at the Festival of Biologics USA

(3/24, Biosimilars Forum) ...Hillel P. Cohen, Chair of the Scientific Affairs Committee for the Biosimilars Forum, will speak at the Festival of Biologics USA 2025 on April 24, 2025, to discuss importance of streamlining biosimilar development. Specifically, the presentation will focus on device selection for biosimilars and interchangeable biosimilars... Full

Trump Picks Susan Monarez to Run the CDC

(3/25, Sarah Owermohle and Helen Branswell, STAT) ...After the chaotic withdrawal of President Trump's previous nominee to lead the Centers for Disease Control and Prevention, the president selected the CDC's acting director, Susan Monarez, to lead the agency... Full

Prescription Drug Affordability Board Vetoed Again by Youngkin

(3/24, Nia McMillan, ABC 8 News) ...Gov. Glenn Youngkin (R) vetoed several bills on Monday, including one that would have created a Prescription Drug Affordability Board. The purpose of House Bill 1724, per its text, was to "protect the citizens of the Commonwealth and other stakeholders within the healthcare system from the high costs of prescription drug products."... Full

House Advances Bill to Lower Insulin Costs

(3/24, Oklahoma House of Representatives) ...A bill that would lower insulin costs and improve access to affordable prescription drugs through a new state-run program passed the House floor today with a 77-13 vote. The bill authored by Rep. Eddy Dempsey, R-Valliant, now moves to the Senate for further consideration... Full

MILLER-MEEKS: Lowering Prescription Drug Prices Not a Partisan Issue

(3/24, Rep. Mariannette Miller-Meeks, Independent Advocate) ...Americans are struggling under the burden of skyrocketing prescription drug prices, and one of the biggest culprits behind these costs is the unchecked power of Pharmacy Benefit Managers (PBMs). These middlemen have amassed excessive control over drug pricing, driving up costs for patients while squeezing out local pharmacies...Congress must act now to pass the DRUG Act and stop PBMs egregious, profiteering opaque practices. Iowans and all Americans deserve a system that prioritizes transparency, fairness, and affordability. I will continue fighting to make that a reality... Full

Branded Pharma & Generics Industries At Odds Over UK VPAG Framework

(3/24, Eliza Slawther and Dave Wallace, Pink Sheet) ...The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning "as intended" and opposes any changes... Global Sub. Full

BGMA Hits Back At ABPI Complaints Over UK Pricing Scheme

(3/24, Dave Wallace, Generics Bulletin) ...Originators have claimed that a levy on suppliers as part of VPAG makes the UK "un-investable" and is out of proportion with other similar European rebate mechanisms, with brand companies urging revisions to the scheme. But generics and biosimilars firms say that VPAG is in fact "delivering precisely as it was intended," with the sector opposed to any changes... Global Sub. Full

EU Marketing Approval Gap Between Lilly's Donamemab and Eisai's Leqembi Could Narrow

(3/24, Francesca Bruce, Pink Sheet) ...Eliy Lilly's donanemab for Alzheimer's disease is among the drugs that are this week up for an opinion from the European Medicines Agency's committee, the CHMP, as to whether or not they should be approved for marketing across the EU. Other products that will be discussed include Veroa/Akebia's ferric citrate coordination complex for treating iron deficiency anemia in adult chronic kidney disease patients with elevated serum phosphorus level and atropine for treating the progression of myopia in children aged three to 18 years. Opinions are also due on three biosimilars: two denosumab products and ustekinumab... Global Sub. Full

DIA Europe: Variations Regulation Expected to Ease Postapproval Changes for Pharmaceuticals

(3/24, Joanne S. Eglovitch, Regulatory Focus) ...The recent EU Variations Regulation that took effect in January is expected to simplify and future-proof the process for implementing manufacturing changes for medicinal products, according to Mónica Perea-Vélez, CMC advocacy and policy director at GSK, who spoke at DIA Europe 2025 on March 19... Full

Polish Presidency Confident Council Will Agree On Pharma Package Under its Watch

(3/25, Sarantis Michalopoulos and Thomas Mangin, Euractiv) ...Poland's rotating EU presidency is aiming for the Council to adopt its position on the long-awaited pharmaceutical package before it hands over the rotating presidency to Denmark, a diplomat close to the matter told Euractiv. Earlier, diplomatic sources told Euractiv the Poles had told other EU partners that they wanted a deal before the Danes take over the EU presidency in the second half of 2025, specifically by May... Sub. Req’d

Swiss Pharma Says Cost Cutting Could Threaten Drug Access

(3/24, The Pharma Letter) ...Interpharma has criticized Switzerland's latest healthcare cost-cutting package, passed in a final parliamentary vote, noting that the legislation will imperil patient access and supply security. The so-called Cost Containment Package 2 introduces further price pressure on drugmakers, who say they already contribute 1.5 billion Swiss francs ($1.7 billion) annually in system savings through regular price reductions. Interpharma, which represents research-based pharma companies in Switzerland, warned that the measures have pushed the sector to a breaking point... Sub. Req’d

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