Monday, December 16, 2024

‘We Can't Search Forever:' Drug Shortage Leaves Ontario Family Scrambling to Find Epilepsy Medication

(12/14, Codi Wilson, CP24) ...In a statement, Teva Canada Limited said the main reason why these tablets are backordered is due to a "complex international supply chain for the various components of the product including a delay in receiving the required active pharmaceutical ingredient (API) from our supplier in Europe."... Full

Blow For Sandoz And Boehringer As PBM OptumRx Deletes Humira Biosimilars

(12/13, Dean Rudge, Generics Bulletin) ...UnitedHealth Group's in-house pharmacy benefit manager Optum Rx will favor Amgen's Amjevita (adalimumab-atto) over Sandoz's Hyrimoz (adalimumab-adaz) and Boehringer Ingelheim's Cyltezo (adalimumab-adbm) in the US beginning January 1, 2025, according to the firm's recently-published 2025 Select Standard Formulary... Global Sub. Full

Glenmark Pharma Arm Launches Seizure Drug in US

(12/14, Business Standard) ...Glenmark Pharmaceuticals announced that its US-based subsidiary, Glenmark Pharmaceuticals Inc., USA, has launched Lacosamide oral solution, in the U.S. market. The newly launched drug is bioequivalent and therapeutically equivalent to the reference listed drug, Vimpat oral solution of UCB, Inc... Full

Celltrion Snatches First Canadian Xolair Biosimilar Approval

(12/13, Urte Fultinaviciute, Generics Bulletin) ...Health Canada has approved Celltrion's Omlyclo (omalizumab), marking the country's first and only biosimilar rival to Novartis/Genentech's Xolair. Previously referred to as CT-P39, Omlyclo received approval for all of the originator's indications: chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps... Global Sub. Full

Celltrion Secures European Approval Recommendations for Four Biosimilars

(12/16, Kim Min-jee, Korea IT Times) ...On December 16, Celltrion announced that it has received recommendations for European market authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency for four biosimilars. These include Avtozma (development name: CT-P47), a biosimilar of Actemra (European name: RoActemra); Eydenzelt (development name: CT-P42), a biosimilar of Eylea; and two biosimilars of Prolia-Xgeva, Stoboclo and Osenvelt (development name for both: CT-P41)... Full

Aurobindo Pharma Arm CuraTeQ Gets European Body's Nod for Filgrastim Biosimilar

(12/13, Jomy Jos Pullokaran, CNBC TV-18) ...The CHMP recommendation is a critical step towards obtaining marketing authorisation for filgrastim biosimilar Zefylti in the European Union. Zefylti treats neutropenia and the mobilisation of peripheral progenitor cells (PBPCs). Shares of Aurobindo Pharma Ltd ended at 1,207.95, down by 7.20, or 0.59%, on the BSE... Full

Accord Healthcare is Granted Marketing Authorisation for IMULDOSA®, Ustekinumab Biosimilar to Stelara®

(12/16, Accord Healthcare) ...Accord announces that the European Commission (EC has granted marketing authorisation for Imuldosa® (development code: DMB-3115), a biosimilar to Stelara®, indicated for a range of immune medicated inflammatory diseases...The marketing authorisation paves the way for the launch of Imuldosa® in the EU ustekinumab market, valued at approximately €2.9 billion (US$3.18 billion) according to IQVIA MAT June 2024 data... Full

Bio-Thera Solutions Expands Partnership with SteinCares in LATAM with Addition of a Third Biosimilar to Partnership

(12/16, Bio-Thera) ...Bio-Thera is responsible for completing the development of each biosimilar and for regulatory filing with FDA and EMA that will support regulatory filings in the LATAM region. The company will also be liable for the commercial supply of the biosimilars out of its manufacturing facilities in Guangzhou, China. SteinCares' extensive experience and understanding of the Latin American healthcare system will ensure an optimal go-to-market strategy and maximize product access in the region. This partnership will leverage SteinCares' strong local presence, and sales and marketing capabilities in the region... Full

FTC OKs Novo-Catalent Deal in Major Win for Novo Nordisk's GLP-1 Manufacturing

(12/14, Anna Brown, Endpoints News) ...After some delay, the Federal Trade Commission has approved Novo Holdings' $16.5 billion acquisition of Catalent, a week after the European Commission's go-ahead. Now that both regulatory parties have approved the merger, the transaction will close in the next few days, Novo Nordisk and Catalent said in separate releases on Saturday. The green light from the FTC was somewhat expected following the EC's approval on Dec. 6. In the EC's announcement, it saw no issue with industry concerns that the acquisition could limit third-party manufacturing options... Full

Neuraxpharm Strikes Long-Acting Injectables Deal With Pharmathen

(12/16, Adam Zamecnik, Generics Bulletin) ...Neuraxpharm has signed a strategic agreement deal with Greek pharma player Pharmathen for the co-development of long-acting injectable therapies for various psychiatric conditions. The deal handed over exclusive rights to such therapies in Europe to Neuraxpharm, alongside select non-European states where the firm already has an established presence. However, Pharmathen will have exclusive rights for the products in North America and other nations not assigned to Neuraxpharm... Global Sub. Full

Aurobindo Pharma, Glenmark, Zydus Recall Products In US

(12/15, Press Trust Of India) ...Drug makers Aurobindo Pharma, Glenmark and Zydus are recalling products in the US market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report of US Food and Drug Administration, Aurobindo Pharma USA Inc, a subsidiary of Hyderabad-based drug maker, is recalling over 1 lakh bottles of Cinacalcet tablets in multiple strengths... Full

J&J Accuses Big Health Insurer of Helping Drain Its Drug Copay Funds

(12/13, Peter Loftus, The Wall Street Journal) ...Johnson & Johnson has sued divisions of health insurer Cigna, accusing them of working with a drug-benefit middleman to drain J&J financial-assistance funds earmarked for patients taking some of its pricier drugs. The move by J&J widens litigation the healthcare giant initiated in 2022 against a middleman, SaveOnSP LLC, and is a new flare-up of long-running tension over drug prices among manufacturers, insurers, pharmacy-benefit managers and other middlemen in recent years... Sub. Req’d

McKinsey Agrees to $650M DOJ Settlement Over Opioid Consulting Relationship with Purdue Pharma

(12/13, Kevin Dunleavy, Fierce Pharma) ...U.S. Department of Justice (DOJ), which was investigating the company's efforts to help Purdue increase its OxyContin sales. In exchange, the DOJ will drop its charges. The agency revealed the agreement in a Friday press release. According to the settlement, which was revealed in a filing in federal court in Abingdon, Virginia, the consulting firm "knowingly and intentionally" conspired with Purdue to misbrand prescription drugs to "turbocharge" their sales... Full

Introduction of Biosimilars Led to More Rebates On Humira

(12/13, Denise Myshko, Formulary Watch) ...In the first year on the market, the uptake of biosimilars for Humira (adalimumab) was low but there was lower net spending and prices on adalimumab, which was likely because of rebates from AbbVie, Humira's manufacturer, according to a new analysis published today in JAMA Health Forum... Full

Strategies for Improving Biosimilar Access and Utilization

(12/15, Skylar Jeremias, The Center For Biosimilars) ...In an interview, Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, outlined key barriers to biosimilar adoption within integrated delivery networks (IDNs) and strategies to overcome them. He highlighted provider apprehension and operational hurdles, such as electronic medical record challenges, as significant obstacles... Full

Trastuzumab's Evergreening Impact On Biosimilars, Health Care Costs

(12/13, Cameron Santoro, The Center For Biosimilars) ...The introduction of trastuzumab biosimilars in the Netherlands led to significant price reductions and increased market share, despite the evergreening strategy implemented by the pharmaceutical company, according to a study published in The European Journal of Health Economics... Full

Managing the High Cost of Specialty Medications

(12/14, Karen Blum, Specialty Pharmacy Continuum) ...Employers and health plans are concerned about managing high-ticket items such as cell and gene therapies, and interested in potential savings from biosimilars, according to a large managed care survey presented at Asembia's AXS24 Summit, in Las Vegas... Full

Weight-Loss Drugs Draw Americans Back to the Doctor

(12/16, Deena Beasley, Reuters) ...An exclusive analysis of hundreds of thousands of electronic patient records by health data firm Truveta found slight, but measurable, increases in first-time diagnoses of sleep apnea, cardiovascular disease, and type 2 diabetes within 15 days of an initial prescription for a GLP-1 weight-loss drug between 2020 and 2024... Full

Lawmakers Edge Toward Health Policy Deal for Year-End Bill

(12/13, Nancy Vu and Nyah Phengsitthy, Bloomberg Law) ...Lawmakers are inching closer to a potential package of health bills to ride on a stop-gap funding measure, with negotiators reviving talks after conversations hit a low point with House Republican leadership Thursday. Lawmakers are looking to extend the Medicare telehealth flexibilities, reauthorize several health programs, and impose tighter requirements on pharmacy benefit managers, according to briefing notes obtained by Bloomberg Government... Sub. Req’d

2025 Outlook: Alternative PBMs Look to Heap Pressure On Industry Titans

(12/16, Noah Tong, Fierce Healthcare) ...Today, the industry's vertically integrated PBMs overwhelmingly dominate pharmacy transactions. There are signs, however, of that beginning to change. Fierce Healthcare spoke with drug pricing consultants and leaders at alternative PBMs to find out where the industry is headed and what reform may be around the corner... Full

How Donald Trump broke the ice between RFK Jr. and drug company CEOs

(12/15, Michael Scherer and Rachel Roubein, The Washington Post) ...They gathered first in a side dining room at his Mar-a-Lago estate, until Trump made clear that he wanted the meal to proceed as something less formal. He proposed that the diners — who included the chief executives of Pfizer, Eli Lilly and the trade group PhRMA — relocate to a second round table on the patio, where music was playing, to better enjoy the winter Palm Beach evening, according to three people familiar with the dinner's discussion, who spoke on the condition of anonymity to describe the private event... Sub. Req’d

Sanders Pressures GSK To Follow AstraZeneca On Green Inhaler Price Caps

(12/13, Maaisha Osman, InsideHealthPolicy) ...AstraZeneca has agreed to apply a $35 out-of-pocket cap to its next-generation, near-zero carbon inhalers once FDA-approved, Senate health committee Chair Bernie Sanders (I-VT) announced Friday (Dec. 13). The move comes as AstraZeneca and GlaxoSmithKline prepare to seek regulatory approval for the climate-friendly inhalers in 2025. Sanders is pressing GSK to make a similar commitment... Sub. Req’d

CMS' Proposed GLP-1 Rule Complicates Path Forward For Legislation

(12/13, Luke Zarzecki, InsideHealthPolicy) ...Advocates are debating which version of the Treat and Reduce Obesity Act (TROA) to continue to champion after the Biden administration proposed a new rule for CMS to cover weight-loss medications for obesity. The proposed rule would only cover those diagnosed with obesity based on body mass index and leaves out those seeking the medications for weight loss, which the bills would also allow CMS to cover but with differing scopes... Sub. Req’d

STOP the Big Pharma "Delinking" Bailout

(12/13, PCMA) ...Congress is considering misguided proposals targeting the market-based role of pharmacy benefit companies in the health care system. So-called "delinking" proposals are the most recent, and most catastrophic, policies targeting pharmacy benefit companies to be floated in Washington. These bills would ban market-based incentives for pharmacy benefit companies to secure the most savings possible for patients and plan sponsors on their prescription drug costs through rebates, discounts, and other price concessions... Full

Feds Threaten Sanofi with Sanctions Over Plan to Change Payment Terms for a Federal Drug Discount Program

(12/14, Ed Silverman, STAT Plus) ...In a Dec. 13 letter, the Health Resources & Services Administration said that if Sanofi proceeds with its plan, the company could be terminated from the 340B Drug Discount Program. The agency also wrote that the changes require approval by the U.S. Department of Health and Human Services, which oversees the agency. Consequently, HRSA instructed the drugmaker to immediately halt its plans... Sub. Req’d

Will The New Administration's FDA Be A Threat Or An Opportunity For The Public's Health?

(12/13, Aaron S. Kesselheim Joshua M. Sharfstein, Health Affairs) ...The immediate aftermath of the 2024 presidential election has brought renewed attention to regulatory policy at the U.S. Food and Drug Administration . One cause is Robert F. Kennedy, Jr., the ally of President-elect Trump who has opposed widespread use of routine vaccines and praised the use of ivermectin and hydroxychloroquine for treatment of COVID19 infection. He recently called for the agency to end the "aggressive suppression" of unproven therapies including peptides, hyperbaric therapies, and chelating compounds. Trump recently said of Kennedy, "I'm gonna let him go wild on medicines," and has proposed he become Secretary of Health and Human Services, the agency that oversees the FDA... Full

ANDA Yo-Yo: FDA Receives Second-Lowest Submission Count In October After September Bolus

(12/14, Derrick Gingery, Pink Sheet) ...The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow...The 14 ANDAs submitted in October were the second-lowest monthly total in the GDUFA era. Industry experts said some sponsors may have rushed to submit applications in September before user fees increased. When fees declined submissions were higher in October, when the new fee came into effect, compared to the previous month... Global Sub. Full

New FDA Center To Guide Use Of Real-World Evidence For Drugs

(12/13, Jessica Karins, InsideHealthPolicy) ...FDA's drug center is launching a new "Center for Real-World Evidence Integration" (CCRI) to promote use of real-world data and real-world evidence in regulatory decision-making, including use of artificial intelligence to gather the data for drug development and post-market safety... Sub. Req’d

Amid Pollution Woes, Asthma Drug Demand Drives Pharma Retail Market Growth in November

(12/14, The Economic Times) ...India's pharmaceutical retail market rebounded in November with double-digit growth, fueled by increased demand for dermatological, cardiac, and respiratory medications. Foracort led sales, followed by Augmentin and Glycomet GP. Sun Pharma maintained market leadership. Analysts predict continued growth, boosted by new product launches, including anticipated generic GLP-1 drugs in 2025... Full

Barrier-Free Regulatory Regime for Biosimilars Promised for BRICS Countries

(12/13, The Pharma Letter) ...The HSE University BRICS Competition Law and Policy Centre has summarized the first results of its annual analytical study on bringing biologics to the BRICS market. One of the conclusions of the report was the need to conduct a large-scale sectoral study on the removal of barriers in the pharmaceutical industry in the BRICS region—comprising Brazil, China, Egypt, Ethiopia, India, Iran, Russia, South Africa and United Arab Emirates... Sub. Req’d

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