Thursday, March 20, 2025

Walmart Pursues Generics Industry Leaders Over Price-Fixing

(3/19, Dave Wallace, Generics Bulletin) ...In the near-700-page complaint, Walmart says the generics firms engaged in "a wide-ranging conspiracy to fix, maintain, and/or stabilize the prices, rig bids, and engage in market and customer allocations of hundreds of different generic drugs from at least May 2009 to the present, in violation of federal antitrust laws," claiming that the "unlawful conduct caused Walmart to pay more than it should have for those drugs." The long list of companies cited in the complaint reads like a Who's Who of the generics industry, including Actavis, Alvogen, Amneal and Aurobindo, along with Dr Reddy's, Glenmark, Hikma and Lupin, as well as the likes of Sandoz, Teva, Viatris, Wockhardt and Zydus... Global Sub. Full

B.C. Government Opioid Case Can Move Ahead, Appeal Court Rules

(3/19, Jeremy Hainsworth, New Westminster Record) ...B.C.'s Court of Appeal has upheld a lower court decision that the provincial government can sue opioid-distributing companies in the province's supreme court as a putative class-action suit...Named as defendants in the case are...Teva Canada Innovation G.P.-S.E.N.C., Teva Canada Limited, Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd... Full

Optum is Changing the Way it Pays Pharmacies

(3/20, Caitlin Owens, Axios) ...Optum said its payment changes, which are effective immediately and will be fully implemented by 2028, address "a legacy, industry-wide model that was originally designed to help promote the use of affordable generics," and the new models will align "more closely to the costs pharmacies may face due to manufacturer pricing actions." "This move will help correct imbalances in how pharmacies are paid for brand and generic drugs and will ensure greater access to medicines for patients across the country," OptumRx CEO Patrick Conway said in a statement... Full

UnitedHealth Will Reimburse Pharmacies More for Brand-Name Drugs

(3/20, Ike Swetlitz and John Tozzi, Bloomberg Law) ...Pharmacy benefit managers have traditionally compensated pharmacists more for cheaper generic medicines to encourage their use, said Patrick Conway, chief executive officer of UnitedHealth's Optum Rx unit. But generic adoption has plateaued, and Conway said the old system discouraged some pharmacies from stocking newer branded drugs like diabetes and weight-loss shots. "We want them to stock the drugs because we want people to be able to get the drugs wherever they go," Conway said in an interview... Sub. Req’d

Alvotech Acquires Xbrane's R&D Operations in Sweden and Further Affirms its Global Leadership Position in Biosimilars Development and Production

(3/20, Alvotech) ...Alvotech...today announced the acquisition of Xbrane Biopharma AB's R&D operations and a biosimilar candidate, further expanding Alvotech's development capabilities, and establishing a footprint in the Swedish life science sector. The Acquisition includes Xbrane's R&D operations based in Campus Solna, at the Karolinska Institute outside Stockholm, Sweden, as well as the biosimilar candidate XB003, referencing Cimzia® (certolizumab pegol)... Full

Sanofi Pays $600M Upfront for Dren Bio's Bispecific in Latest Immunology Play

(3/20, James Waldron, Fierce Biotech) ...The CD20-directed antibody, dubbed DR-0201, is a bispecific myeloid cell engager Dren has been evaluating in a phase 1 trial for B-cell non-Hodgkin lymphoma. While the biotech has yet to announce any clinical results for the antibody, Sanofi implied in a March 20 release that it's pleased with the "robust" B-cell depletion it has seen so far... Full

Eli Lilly Beats Novo Nordisk to Launch Weight-Loss Drug Mounjaro in India, at $50 for 5 mg Vial

(3/20, Rishika Sadam, Reuters) ...Lilly launches Mounjaro in India, beating Novo Nordisk. Mounjaro's 5mg vial priced at around $50, 2.5mg at about $40. Drug's pricing may limit accessibility in India, analyst says... Full

Celltrion Expands Market Presence in Italy with Autoimmune Disease Biosimilars

(3/20, Lee Han-soo, Korea Biomedical Review) ...The company's Italian subsidiary secured contracts in four regional tenders across Piemonte, Valle d'Aosta, Liguria, and Sardegna, covering approximately 10 percent of Italy's ustekinumab market. Under these agreements, Steqeyma will be supplied in these regions until 2028. Celltrion's Humira biosimilar (ingredient: adalimumab), Yuflyma, has also won bids in three strategically important regions—Lazio, Lombardia, and Umbria. As a result, Yuflyma will be supplied in Lazio and Lombardia for three years and in Umbria for two years, starting this month... Full

MSN's US Entresto Generic Blocked In Part For Being Too Similar To The Brand

(3/19, Dean Rudge, Generics Bulletin) ...Novartis' multi-front legal battle against MSN Laboratories over its Entresto blockbuster in the US has taken yet another twist, with a federal district court in New Jersey finding that a preliminary injunction was warranted against MSN's product on the basis of infringement of Novartis' trade dress... Global Sub. Full

FDA Warns Aspen Pharmacare, Africa's Biggest Drugmaker, Over Sterility Issues at a Key Plant

(3/19, Ed Silverman, STAT+) ...The U.S. Food and Drug Administration has warned Aspen Pharmacare, the largest pharmaceutical company in Africa, that it had failed to take sufficient steps to prevent microbial contamination at a key facility that makes eye drops and many other medicines that require sterile production... Sub. Req’d

Cigna Closes $3.3B Sale of Medicare Plans to HCSC

(3/19, Paige Minemyer, Fierce Healthcare) ...Cigna has officially sealed the deal on the $3.3 billion sale of its Medicare business to Health Care Service Corporation...While it will no longer operate the Medicare unit directly, Cigna said it will continue to provide pharmacy benefit management and other services through its Evernorth division, as part of an agreement with HCSC... Full

Just How Steep Is the Drug Patent Cliff? Ask These Pharmas

(3/19, Dan Samorodnitsky, BioSpace) ...With Keytruda, the best-selling drug in the world, facing the end of exclusivity in 2028, BioSpace looks at five drugs that have taken the leap off the patent cliff... Full

Adult ADHD Prescriptions Still On The Rise, Especially Among Older Women

(3/19, Linda Carroll, NBC News) ...There's been an overall jump in ADHD prescriptions since the pandemic and the rise of telehealth. The new analysis, published in JAMA Psychiatry by researchers at the National Institute on Drug Abuse, also looked into how the medications are being misused — that is, taking more of the drugs than prescribed, taking them at times that differed from what the doctor ordered or using medication from someone else's prescription... Full

PBMs, Insurers Argue Against CMS Coverage Of Weight Loss Drugs

(3/19, Luke Zarzecki, Inside Health Policy) ...The Office of Management and Budget (OMB) is slated to meet with stakeholders arguing both for and against a proposed CMS rule to cover anti-obesity medications (AOMs), with the lobby representing pharmacy benefit managers (PBMs) arguing against the Biden-era policy as the new administration decides whether to finalize it... Sub. Req’d

PBMs, Pricing, and Policy: The Fight for Fair Access to GLP-1s

(3/19, Alexandra Gerlach, Pharmacy Times) ...As the cost of health care continues to rise, access to life-changing medications remains a pressing issue for patients and providers alike. Glucagon-like peptide-1 (GLP-1) receptor agonists have emerged as powerful treatments for obesity and type 2 diabetes, with growing potential for additional therapeutic applications. However, despite their clinical benefits, the high cost of these medications—paired with restrictive insurance coverage—has left many patients unable to access them... Full

Health Orgs Tweak Messaging As Federal Policy Priorities Shift

(3/10, Maya Goldman, Axios) ...Reality check: Leaning too hard into the Trump administration rhetoric too quickly may not ease Trump world's suspicions about some companies' motives. "I almost think it's a risk because people will just roll their eyes at the companies who did 180s," one conservative health care policy expert not in the administration told Axios... Full

Trump Administration Extends Opioid Emergency As Fentanyl Deaths Drop

(3/19, Brian Mann, NPR) ...The Trump administration is extending through mid-June an emergency declaration linked to the opioid overdose crisis that was set to expire on Friday. In a statement, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. acknowledged drug deaths in the U.S. "are starting to decline" but said the Trump administration will continue treating the opioid crisis as "the national security emergency that it is."... Full

Drug Overdoses Are On the Decline, in Charts

(3/20, Julie Wernau and Brianna Abbott, The Wall Street Journal) ...Over the 12 months ending in October 2024, the country saw a 25% decline in overdose deaths compared with the same period the year prior, according to the latest preliminary estimates from the Centers for Disease Control and Prevention. About 82,000 overdose deaths were reported. The leading factor? A falling number of fatalities involving synthetic opioids, a drug class in which bootleg fentanyl is the big killer... Full

HHS Wants 340B Rebate Debate Out Of Courts, Returned To Government

(3/19, Cathy Kelly, Pink Sheet) ...An HHS legal brief argues company lawsuits seeking immediate clearance to use rebates in 340B are premature and that the department has merely used a ‘measured approach' in weighing the possibility. Past experience suggests otherwise, a pricing expert said... Global Sub. Full

Deals, Factory Moves, Task Forces: Globe Braces for Trump's ‘Dead Serious' Tariff Plan

(3/19, Tom Howeel Jr., The Washington Times) ...Some nations are taking a collaborative approach. Prime Minister Keir Starmer recently told Parliament that Britain and the U.S. were "negotiating an economic deal, which covers and will include tariffs if we succeed." Commerce Secretary Howard Lutnick and U.S. Trade Representative Jamieson Greer met Wednesday with British officials, and efforts to strike a deal "will continue to unfold over the coming days and weeks," according to the Commerce Department... Full

Mid-March 2025 Peek at ANDA Approval Actions – Is There Concern Around the Corner?

(3/19, Bob Pollock, Lachman Consultants) ...The old saying "March comes in like a lion and goes out like a lamb" might apply to March 2025 as the OGD has issued 34 full-approval actions and 17 tentative-approval actions through March 17th. The biggest day was the first business day of March when the OGD pushed out eleven full- and four tentative-approval actions. A mid-month that starts with a total of 51 approval and tentative-approval actions could lead to a new high thus far in FY 2025—that is, unless the second half of the month becomes more lamblike... Full

US FDA's Speed Of Work Under Trump Quietly Raising Industry Concerns

(3/19, Sarah Karlin-Smith, Pink Sheet) ...Industry is starting to quietly raise concerns that the FDA's productivity is slowing due to the administration change. While most current complaints are minor, with more staff expected to leave voluntarily or through layoffs, fears of missed user fee deadlines are growing. One source said the number of complete response letters for drugs and biologics has increased, but the exact cause of the rejected applications is difficult to know... Global Sub. Full

Prescription Drug Affordability Boards: A Threat to Patients and Innovation

(3/20, Keith Hodges, Cardinal News) ...We need long-term solutions to make medications more affordable — solutions that tackle inefficiencies in the healthcare system and bring greater transparency. Rather than providing meaningful reform, PDABs distract from the deeper issues while jeopardizing medical innovation and economic opportunities. Patients deserve better. Let's learn from the failures of other states and choose a path that protects both affordability and innovation — because the health and future of our families depend on it... Full

Ohio Pharmacy Closures Lead to Fears of Medicine Deserts, Especially in Rural Areas

(3/19, Marty Schladen, Ohio Capital Journal) ...The number of retail pharmacies in Ohio last year dropped below 2,000, according to a data tool made public last month by the Ohio Board of Pharmacy. That's worsening fears that especially in low-income rural areas, underserved people will find it even harder to get medicine, vaccines, and advice about how to handle chronic health conditions... Full

NJ's Drug Industry Facing More Stress

(3/18, Michael L. Diamond, Asbury Park Press) ...New Jersey's powerhouse pharmaceutical industry, already under pressure to rein in prices, is facing new headwinds from a Trump administration that is calling into question vaccine effectiveness and trying to cut research funding. The moves, industry experts said, could douse an era of scientific breakthroughs with a wave of new technology, from artificial intelligence to digital imaging... Full

Higher Medicine Sales Tax Makes UK ‘Uninvestable', Drugmakers Warn

(3/19, Hannah Kuchler, Financial Times) ...The Association of the British Pharmaceutical Industry on Thursday said the voluntary scheme for branded medicines pricing, access and growth (Vpag) was leading companies to cut headcount and abandon partnerships with the NHS. Some pharmaceutical companies were delaying launching some new medicines in Britain because of the clawback tax, the lobby group said, adding that the "levy makes the UK uninvestable"... Sub. Req’d

UK is Becoming An 'Outlier' for Pharma, Hitting Investment

(3/20, Phil Taylor, Pharma Phorum) ...The pharma industry in the UK has doubled down on its resistance to the increase in levies imposed on medicine sales, with a string of company leaders calling for an urgent rethink by the government...Following the decision in December to set the VPAG rate at 22.9% for 2025, "global boardrooms are closely monitoring developments, concerned that the UK is further exacerbating its position as an international outlier," according to Russell Abberley, general manager of Amgen UK & Ireland. It has already been speculated that AstraZeneca's termination of a plan to invest £450 million in a new vaccine manufacturing plant in the UK came about in part because of the big increase in the VPAG rate for newer medicines from around 15% in 2024 and mid-single digits in the pre-pandemic era... Full

US Pharma Firms Assess Potential of Shifting Work from Ireland if Tariffs Hit Hard

(3/20, John Burns, Irish Independent) ...According to PwC Ireland, which is advising firms in the sector, many are "struggling" to cope with the challenge, are pausing decisions on investment, and are feeling high levels of frustration and worry...There are over 85 companies operating in the sector, employing about 50,000 people. Most of the big US companies have operations here, including Pfizer, Eli Lilly, Johnson & Johnson, and AbbVie. Mr Harrison said many pharma companies have been in Ireland a long time, and it would be difficult for them to change supply chains. They also need a base here to manufacture products for the non-US market... Sub. Req’d

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

(3/19, Eliza Slawther, Pink Sheet) ...The Dutch health technology assessment agency is willing to use real-world data in appraisals this is difficult under the current framework, an executive from Gilead says. In Germany and Italy, meanwhile, there is less appetite from HTA agencies and payers to use RWD, an exceutive from cell therapy manufacturer Autolus says. The EU HTA Regulation also does not include a framework for the use of RWD, which is "alarming," according to the Autolus executive... Global Sub. Full

Health Canada Addresses Growing Diversity Of Co-Packaged Drugs

(3/19, Vibha Sharma, Pink Sheet) ...Health Canada has drawn up a draft guideline for co-packaged drug products to address their increasing variety. The draft guidance aims to tackle the unique challenges posed by co-packaged drug products, including identification, labeling and post-marketing changes. The guideline, when finalized, will replace Health Canada's existing 1997 policy on the identification and labeling of drug products in kits... Global Sub. Full

Government's Penny-Pinching Approach Driving Medicine Shortages, CCA Warns

(3/19, Longjam Dineshwori, Pharmacy Business) ...In a newly released paper, the CCA highlighted how the government has squeezed the price it is willing to pay for many medicines, making the UK a less attractive market for pharmaceutical manufacturers and suppliers. As a result, many common medicines often go into short supply, forcing the NHS to pay significantly higher prices through temporary price concessions to secure the supply of those medicines—far outweighing the initial cost savings... Full

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