Tuesday, March 4, 2025

Fresenius Becomes Latest To Launch US Stelara Rival

(3/3, Dave Wallace, Generics Bulletin) ...Meanwhile, providers have started to reveal which Stelara biosimilars are going to be available on their formularies. MedImpact Healthcare Systems, which describes itself as "the largest independent pharmacy benefit and health solutions company," has indicated that it will cover both the Teva and Alvotech partnered Selarsdi (ustekinumab-aekn) biosimilar and Biocon Biologics' Yesintek (ustekinumab-kfce) version... Global Sub. Full

Formycon Gets UK Nod For Eylea Biosimilar

(3/3, Dave Wallace, Generics Bulletin) ...Formycon has celebrated receiving a UK approval for its Ahzantive biosimilar version of Eylea, setting up a launch from partner Teva – which has already seen success in the UK market with the partners' Lucentis biosimilar, Ongavia...Teva already markets another Formycon ophthalmic biosimilar in the UK, the Ongavia (ranibizumab) rival to Lucentis that is approved elsewhere in Europe as Ranivisio and in the US as Cimerli. Formycon said the prior ranibizumab arrangement meant that Teva could "synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field" to promote Ahzantive... Global Sub. Full

Viatris ‘Actively Launching' Glucagon As It Looks To Deliver On Pipeline Promise

(3/3, Dean Rudge, Generics Bulletin) ...Viatris says its US generic glucagon 1mg/vial injectable is "actively being launched," as the firm looks to deliver on its long-promised string of complex injectables going into a challenging 2025...For the company's proposed generic to octreotide, Teva last year leapfrogged Viatris, launching the first-and-only US generic version of the synthetic polypeptide indicated to treat acromegaly and severe diarrhoea for carcinoid syndrome... Global Sub. Full

Celltrion Wins FDA Approval for Denosumab Biosimilars, Eyes 9 Trillion Won Market

(3/4, Heo Ji-yoon, Chosun Biz) ...Celltrion announced on the 4th that its biosimilar 'Stoboclo-Osenvelt' for the treatment of bone diseases, the biosimilar of the medication 'Prolia-Xgeva,' has obtained approval from the U.S. Food and Drug Administration...Celltrion plans to launch the two products in the United States as early as this year, having completed patent agreements in advance with the original drug developers... Full

Amneal's BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA

(3/3, Amneal Pharmaceuticals) ...Amneal Pharmaceuticals, Inc., a global biopharmaceutical company, and mAbxience today announced that the U.S. Food and Drug Administration has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia® and XGEVA®. mAbxience is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma. Fresenius Kabi is an operating company of Fresenius... Full

Protagonist, Takeda's Profit Sharing Deal Under Spotlight After Phase 3 Blood Disorder Trial Win

(3/3, Max Gelman, Endpoints News) ...Monday's results are a boon for Takeda, which partnered with Protagonist on rusfertide last year for $300 million upfront. Protagonist said it earned a $25 million milestone payment off the study success. It also marks a comeback of sorts for rusfertide, which ran into the FDA's crosshairs during earlier development... Full

Biocon Targets Mid-Teen Revenue Growth with New Product Pipeline

(3/4, Hormaz Fatakia and Mangalam Maloo, CNBC TV-18) ...Siddharth Mittal, Managing Director and Chief Executive Officer of Biocon, said that while new launches will contribute positively to margins, pricing pressure on the existing product base will continue. However, he does not expect any fundamental shift in margins in the coming quarters...Biocon remains confident about growth across all three of its business segments.. The biosimilars segment is set to benefit from upcoming product launches, the generics business is expanding with the GLP-1 opportunity, and Syngene is poised to grow due to factors like the China Plus One strategy, the Biosecure Act, and increased demand for contract manufacturing... Full

African Drugmaker Aspen Says New Latam and Eli Lilly Portfolio Boosting Earnings

(3/3, Nqobile Dludla, Reuters) ...Aspen Pharmacare posted a 5% rise in half-year earnings on Monday and said it expects double-digit revenue and core profit growth in its commercial pharmaceuticals unit in the full year, benefiting from its Latin American portfolio and the roll-out of its weight-loss drug Mounjaro...CEO Stephen Saad told Reuters that the company is seeing increased demand for Mounjaro. "Before we even launched, it had (a) nearly 20% (share) of the (South African) market," he said, based on generated scripts... Full

Lilly's Lower-Cost Zepbound Options Could Ease Patient Transition From Compounded GLP-1s

(3/3, Cathy Kelly, Pink Sheet) ...Lilly CEO David Ricks commented on the possibility that the incoming leadership at the FDA may take a different approach to the GLP-1 shortage issue during a recent event to announce plans for new US-based manufacturing operations. "Of course they're just getting seated now, most of the officials that actually effectuate policies aren't in their chairs during the confirmation process," Ricks said. "In the meantime, our advocacy will be the same. It's just enforce the laws that exist."... Global Sub. Full

Live Updates: Tracking Insurance Coverage for GIP and GLP-1 Agonists Like Zepbound and Wegovy

(3/4, Amanda Nguyen, PhD, GoodRx) ...Despite high demand for GIP and GLP-1 agonists due to their weight-loss benefits, commercial insurance coverage has not improved across the board in 2025. In fact, coverage has become even more restrictive for several popular medications. The number of people with no commercial insurance coverage for Zepbound increased by over 14% in 2025, leaving another 4.9 million people with no coverage. For those who have insurance coverage, over 83% still have to meet additional requirements like prior authorization...The GoodRx Research team is tracking commercial insurance coverage for popular GIP and GLP-1 agonists that have weight-loss benefits... Full

China, India Obesity Problems Driving Global Surge, Study Says

(3/3, Amber Tong, Bloomberg) ...Without drastic intervention, 3.80 billion adults over the age of 25 years will have overweight and obesity around the world by 2050 compared to 2.11 billion in 2021, researchers wrote in a paper published Tuesday in The Lancet, noting how that will be more than half of the likely global adult population at that time. Overweight and obesity are tied to higher risks of diabetes, cardiovascular diseases and certain cancers. The increased disease burdens could translate into "staggering" economic ramifications, the researchers wrote, citing both direct healthcare costs and indirect loss in productivity. Forecasts suggest that, by 2035, the obesity epidemic could lead to a 2.9% reduction in global gross domestic product, equating to a loss of $4 trillion... Sub. Req’d

Biohaven's Ion Channel Drug Fails Pivotal Bipolar Mania Study

(3/3, Lei Lei Wu, Endpoints News) ...The Phase 2/3 study included an estimated 256 people who were voluntarily hospitalized for a manic episode from bipolar disorder. The participants received either Biohaven's drug, known as BHV-7000, or placebo once a day for three weeks, according to a federal clinical trials database. However, the treatment arm "did not statistically separate" from the placebo group on the primary endpoint, Biohaven said in its earnings report Monday. The primary endpoint is known as the Young Mania Rating Scale, an 11-item measure of manic symptoms and their severity... Full

Sinusitis Data from Amgen, AZ's Tezspire Spark 'Best-in-Disease' Talk Amid Sanofi, GSK Competition

(3/3, Angus Liu, Fierce Pharma) ...Already billed as a potential blockbuster, Amgen and AstraZeneca's Tezspire has turned in strong clinical data in chronic rhinosinusitis with nasal polyps (CRSwNP). Tezspire showed numerically better efficacy results in CRSwNP compared with two prominent rivals in the three drugs' separate studies. However, separate teams of analysts at William Blair and Leerink Partners stopped short of handing Tezspire the crown in the indication, citing trial design differences that likely play into the cross-trial comparisons... Full

ICER Finds GSK Inhalers Offer Advantages Over Generic Competitors

(3/3, Zachary Brennan, Endpoints News) ...The higher prices of two COPD inhalers from GSK that are targeted in the second round of government drug price negotiations are justified because of several advantages over generic competitors, according to a new report published on Monday from the drug pricing watchdog ICER... Full

Trelegy and Breo Offer Incremental Improvement Over Generics

(3/3, Denise Myshko, Formulary Watch) ...In this special report, ICER evaluated the evidence of the two COPD treatments and plans to send the public comment submission to CMS as part of its work on Medicare drug price negotiations. ICER reviewers found that comparators for Trelegy Ellipta generally require multiple inhalers administered twice daily and for Breo Ellipta generally require at least one inhaler twice daily. Observational data suggest that patients are more adherent to once-daily therapy, and this may lead to fewer COPD exacerbations, although the benefits are modest, according to ICER analysis... Full

Trump Locks in Canada, Mexico Tariffs to Launch On Tuesday; Stocks Tumble

(3/3, David Lawder, Andrea Shalal, Steve Holland, Reuters) ...U.S. President Donald Trump said 25% tariffs on goods from Mexico and Canada will take effect from Tuesday, pushing North America closer to a regional trade war and sending financial markets reeling...Canada said it would retaliate with 25% tariffs on C$155 billion ($107 billion) worth of U.S. goods if Trump's tariffs went into effect, Prime Minister Justin Trudeau said Monday evening, and urged the White House to reconsider. Trudeau said Canadian tariffs will go into effect for C$30 billion of products at the same time as U.S. tariffs on Tuesday, while duties on the remaining C$125 billion of U.S. goods will apply in 21 days... Full

‘Tariff Taskforce': Pharma Firms Scramble to Prepare Even as Trump Levies Risk Flouting WTO Rules

(3/4, Karen Gilchrist, CNBC) ...Europe's pharmaceutical firms are rushing to prepare for the potential fallout of U.S. import duties, with some forming "tariff taskforces." President Donald Trump on Wednesday signaled that the EU could be next to face sweeping 25% tariffs. It follows an earlier pledge to hit pharma imports with an equivalent charge. Analysts warn that such levies on drug makers could mark an infringement of rules set out by the World Trade Organization... Full

Pfizer Could Shift Overseas Production to US if Trump's Pharma Tariffs Take Hold, CEO Says

(3/3, Fraiser Kansteiner, Fierce Pharma) ...At the TD Cowen event Monday, Bourla admitted that the situation could be tricky for pharma companies, given the significant volumes of drugs—both generic and innovative—that are produced outside of the U.S. Still, the CEO stressed that Pfizer is likely set up for success no matter what comes. Pfizer already has 13 U.S. manufacturing sites up and running, including several "megasites" for sterile injectables and antibody manufacturing, according to Bourla... Full

Novo Nordisk Gives Unclear Answer On Participation In Medicare Negotiations Round Two

(3/3, Maaisha Osman, Inside Health Policy) ...Novo Nordisk would not say whether it has agreed to participate in the second round of Medicare drug price negotiations under the Inflation Reduction Act, while reiterating to Inside Health Policy its position that CMS' decision to group its selected GLP-1 drugs as a single item does not meet the requirements of the statute. But Pfizer, Astellas, GlaxoSmithKline, Bristol Myers Squibb, AstraZeneca and Amgen confirmed to Inside Health Policy they have agreed to participate in the second round of negotiations... Sub. Req’d

Medicare Cancer Drug Bill Seeks to Restore Delivery for Patients

(3/3, Tony Pugh, Bloomberg Law) ...A battle over legislation that would make it easier for Medicare cancer patients to get their drugs may reignite this week when a key Republican lawmaker is expected to reintroduce the proposal. The measure (H.R. 5526) was passed in the House in September 2024, but stalled in the Senate amid opposition from the pharmacy industry. Rep. Diana Harshbarger (R-Tenn.), a pharmacist, said in a statement to Bloomberg Law the legislation "is one of my top healthcare priorities, and I expect to reintroduce it this week."... Sub. Req’d

Cassidy Staffer: TROA On Hold Until CMS AOM Rule Is Decided

(3/3, Luke Zarzecki, Inside Health Policy) ...Sen. Bill Cassidy's (R-LA) office is in discussions with the Trump administration to finalize coverage of anti-obesity medications after the Biden administration proposed a rule that would do so. Legislative movement on the Treat and Reduce Obesity Act (TROA) is paused until the decision is made, but the chances of the introduced version of TROA passing without the CMS rule proceeding remains slim... Sub. Req’d

Top HHS Spokesman Abruptly Resigns After Reports of Tensions with RFK Jr. and His Team

(3/3, Sarah Owermohle, STAT+) ...The top spokesman at the Department of Health and Human Services abruptly resigned Friday following tensions with Secretary Robert F. Kennedy Jr. and his team, according to two people familiar with his departure. Thomas Corry, who had only recently taken on the role of assistant secretary for public affairs, announced his immediate departure on Monday... Sub. Req’d

Makary Would Have Wide Leeway To Make GLP-1 Compounding Decisions As US FDA Commissioner

(3/3, Sarah Karlin-Smith, Pink Sheet) ...FDA Commissioner nominee Martin Makary's ethics pledges related to his former compounding employers and investments appear to comply with the law, ethics experts said. Once Makary divests his financial ties, he will be able to participate in most general policy work related to compounding. However, ethics experts argued the law is fairly weak and ideally Makary should be recused from all compounding work... Global Sub. Full

Compounding US FDA's Problems: The High Stakes In GLP-1 Shortage Actions

(3/3, Michael McCaughan, Pink Sheet) ...Challenges to the FDA's decision ending the shortage of GLP-1 medications could impact the agency's ability to prevent and mitigate all drug shortages. If courts require the FDA to use notice-and-comment rulemaking to update a shortage, its ability to maintain a timely drug shortage list likely would be crippled. Court challenges of compounding laws also limited the FDA's ability to regulate pharmaceutical manufacturing promotion... Global Sub. Full

Experts: Cuts at FDA Could Jeopardize US Standing in Clinical Research, Product Innovation

(3/3, Joanne S. Eglovitch, Regulatory Focus) ...The staffing cuts at the US Food and Drug Administration (FDA) have created a climate of uncertainty surrounding clinical trials. As a result, many companies are considering the possibility of developing drugs in other countries. This situation is perceived by some as a "gift to China," which has been intensifying its efforts in the pharmaceutical space, according to Jeremy Levin, CEO of Ovid Therapeutics... Full

Official December 2024 OGD Stats Finally Out Along with New Mean and Median Approval Times

(3/3, Bob Pollock, Lachman Consultants) ...Almost two months to the day, the OGD published its final December statistical report along with the Quarterly Report on approval times for the first three months of FY 2025. It appears that the OGD did better in ANDA approval and tentative approval (TA) actions than we had reported back on January 6, 2025 in our unofficial review of December's available data... Full

California Made a Big Bet On Producing its Own Insulin. There's No ‘Date Certain' for Delivery

(3/3, Kristen Hwang, CalMatters) ..."We are more than a year behind schedule with no end in sight," said Christine Fallabel, regional director for government affairs for the association, during a recent Senate oversight hearing on the initiative. During the hearing, representatives for the Newsom administration said they could not provide a timeline for when the state's insulin would be for sale. Fallabel said Californians could be waiting until 2030... Full

Zay Bill Targets Prescription Middlemen

(3/3, Dirk Rowley, WANE) ...While Indiana legislators have focused much of their attention on hospital prices during the first half of the 2025 session, State Senator Andy Zay (R-Huntington) has taken a different route to save the state money. Zay wants to better regulate Pharmacy Benefit Managers (PBMs) in Indiana's state employee health plan and the Hoosier Medicaid plan. Zay estimated the state would save between $150 to $200 million a year if his bill were to become law. Zay's bill was rolled into Senate Bill 140, which was sent to the House Committee on Insurance on Monday... Full

After Canada Required Pharma to Pay Fees, Drug Agency Recommended Coverage More Often

(3/3, Ed Silverman, STAT+) ...After a Canadian agency began requiring application fees from drug companies more than a decade ago, the odds that a drug — other than cancer treatments — would receive a recommendation for government funding rose dramatically, according to a new study. And the author suggested the fees created a conflict of interest that may have influenced agency decision-making... Sub. Req’d

EFPIA Has its Say On Critical Medicines Act

(3/3, The Pharma Letter) ...The Critical Medicines Alliance Strategic Report has been published in a bid to develop a coordinated, European industrial framework to prevent and mitigate shortages of crucial medical products...The Strategic Report aligns with many of the EFPIA's policy recommendations for a Critical Medicines Act. However, the group does have some remaining concerns regarding its implementation. "We would urge that the act is subject to ongoing monitoring and assessment so that policies are coherent, workable and effectively support our ability to get essential medicines to patients in Europe"... Sub. Req’d

Bitter Pill or Market Opportunity – How Will EU Pharma Adapt to RFK Jr's Health Reforms?

(3/4, Brian Maguire, Euractiv) ...Elizabeth Kuiper, Associate Director European Policy Centre told Euractiv: "The medicines review process of the US Federal Drug Agency (FDA) is recognised worldwide as the gold standard. FDA decisions are adopted by many countries worldwide without regulatory bodies. "It is likely that the FDA's resources will be reviewed critically by DOGE. A decrease in the FDA's resources may have consequences for regulatory bodies, placing a greater onus on the European Medicines Agency (EMA)."... Full

IPHA Paper Pushes for Faster Patient Access

(3/3, The Pharma Letter) ...The Irish Pharmaceutical Healthcare Association (IPHA) has published a position paper on the 2025 Program for Government Commitments calling for faster and fairer access to medicines. This paper, for the first-time, measures access to medicines timelines against the Health Act 2013, and finds that patients in Ireland continue to wait almost two years to access new life-enhancing treatments... Sub. Req’d

Roche Korea's Multiple Sclerosis Drug Scores Reimbursement

(3/3, Lee Han-soo, Korea Biomedical Review) ...Roche Korea said its multiple sclerosis (MS) treatment, Ocrevus (ingredient: ocrelizumab), started receiving reimbursement from last Saturday...With this reimbursement approval, Ocrevus is now covered as a monotherapy for patients with relapsing forms of multiple sclerosis (RMS), including relapsing-remitting multiple sclerosis (RRMS) patients who failed or showed insufficient response to first-line treatments such as interferon ß-1b and are eligible for outpatient treatment, as well as secondary progressive multiple sclerosis (SPMS) patients, where Ocrevus is recognized as a first-line treatment... Full

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