Tuesday, March 18, 2025

All Selected Drugmakers Agree to Second Round of Price Negotiations Under the IRA

(3/17, Nicole DeFeudis, Endpoints News) ...Twelve manufacturers will negotiate the prices of the 15 drugs picked by CMS, including Novo Nordisk's blockbuster GLP-1s Ozempic and Wegovy, Merck's diabetes drug Janumet, and Pfizer's cancer treatment Ibrance. The process formally kicked off earlier this month when each manufacturer signed an agreement to participate, the agency announced on Friday...CMS is expected to submit an initial offer for each drug by June 1. Negotiations will take place over the summer and fall of this year, ending on Nov. 1, and the new prices would take effect in 2027... Full

BCI and Teva Pharmaceuticals Launch Second Edition of "Let's End Breast Cancer Project" at Abetifi

(3/18, Francis Appiah, Modern Ghana) ...Breast Care International (BCI) and Teva Pharmaceuticals have launched the second edition of the "Let's End Breast Cancer Project" at Abetifi in the Kwahu East district of the Eastern Region. This comprehensive project aims to raise awareness, educate communities about breast cancer, and train health personnel to manage it. In partnership with the University of Environment and Sustainable Development, the project will conduct thorough research to identify potential environmental contributors to breast cancer in the Eastern region... Full

Teva, Kerry Pharma Sign Strategic Partnership to Build 4PL New Model, Offering Better Solutions for Patients in GBA

(3/18, China Daily) ...The strategic partnership between Teva and Kerry Pharma has the goal of empowering the health ecosystem through more innovative means and complementary advantages, according to Linda Pang, head of commercials at Teva Greater China. "To deliver swift and reliable services to patients, we would harness more digital solutions in the future, optimizing the safety and efficiency of pharmaceutical logistics," Pang said... Full

Fresenius Reveals Denosumab Launch Details As It Settles US Litigation

(3/17, Dave Wallace, Generics Bulletin) ...Fresenius Kabi has become the latest company to settle litigation with Amgen over biosimilar denosumab, with the German company disclosing to Generics Bulletin details of resultant launch dates for its proposed Prolia/Xgeva rivals in both the US and Europe...The US launch date of "mid-2025" cited by Fresenius aligns with launch dates already obtained by other sponsors that will be looking to capture market share in the second half of 2025, as launches begin from the end of May... Global Sub. Full

Amgen's Bufferless Eylea Biosimilar Again Knocks Back Regeneron's Injunctive Bid

(3/17, Dean Rudge, Generics Bulletin) ...Amgen's biosimilar to Regeneron's Eylea (aflibercept) will remain available on the US market while the two companies continue to litigate over a key patent, after the US Court of Appeals for the Federal Circuit affirmed an order denying the originator's bid for a preliminary injunction...Unlike Amgen, other aflibercept abbreviated biologics license application filers, including Biocon, Formycon, Samsung Bioepis, and Celltrion, have developed biosimilar versions of Eylea that "do contain a separate buffer component," the Federal Circuit observed... Global Sub. Full

Celltrion Targets 5 Tln Won in Sales This Year On Biosimilars

(3/18, Choi Kyong-ae, Yonhap News) ...Celltrion has significantly expanded its global biosimilar lineup, increasing the number of approved products from six to 11. It aims to commercialize 22 biosimilar products by 2030, when the targeted global market size is expected to nearly double to 261 trillion won from 138 trillion won this year. Celltrion said it is targeting to report an average of 30 percent sales growth for three years through 2027 on the back of increased production and cost reduction... Full

AstraZeneca Signs Alteogen Deal Worth Up to $1.35B for Subcutaneous Cancer Drugs Despite Merck-Halozyme Patent Drama

(3/17, Angus Liu, Fierce Pharma) ...Monday, AZ said it has acquired exclusive rights to use Alteogen's hyaluronidase protein, ALT-B4, to develop and commercialize subcutaneous formulations of "several oncology assets."...AZ signed the Alteogen collaboration despite an escalating patent dispute around ALT-B4, a human recombinant hyaluronidase enzyme that can enable a large volume of under-the-skin administration of drugs that are otherwise typically administered as intravenous infusions... Full

Roche's Obesity Deal with Zealand Pharma Tees Up Rival for GLP-1s

(3/17, Amy Baxter, PharmaVoice) ...Under the deal, Roche is plunking down $1.65 billion, including $1.4 billion upfront and $250 million in anniversary payments, to license petrelintide, an amylin analog weekly shot... Full

Aspen Believes It ‘Ticks All The Boxes' As It Begins Submitting GLP-1 Dossiers

(3/17, Dean Rudge, Generics Bulletin) ...South Africa's Aspen Pharma has discussed the "significant progress" it believes it has made in GLP-1s, with an eye on rolling-out semaglutide in non-US and non-EU markets beginning as early as 2026. Aspen Pharmacare expects to be ready to launch at market formation for its proposed semaglutide generics after achieving "confidence now in both the quality and acceptability of [our] dossiers," having made "significant progress" in positioning itself as an owner of the intellectual property, a manufacturer, and in "establishing the appropriate marketing and distribution reach."... Global Sub. Full

Opko, Entera Share Ownership of First Oral GLP-1/Glucagon Agonist Set to Enter Clinic

(3/17, James Waldron, Fierce Biotech) ...The companies' current timetable would involve seeking permission from the FDA "later this year" to enter human trials, according to a March 17 release. The agreement will see Miami-based Opko and Israel-based Entera holding 60% and 40% ownership, respectively, in the program, and sharing the development costs by the same ratio... Full

German Drugmaker Stada Is Pushing Back IPO Until September

(3/17, Swetha Gopinath and Eyk Henning, Bloomberg) ...Bain Capital and Cinven decided to delay the listing due to the recent market volatility, the people said, asking not to be identified because the information is private. They had originally planned to launch the share sale as soon as this week, according to the people... Full

Dismissive Providers, Limited AI Regs, Fake Drugs On ECRI List Of Top Safety Threats

(3/17, Sigi Ris, Inside Health Policy) ...Dismissal of patient concerns by providers, insufficient artificial intelligence governance and increased market penetration of substandard and falsified drugs are on ECRI and the Institute for Safe Medication Practices' (ISMP) list of the top 10 patient safety concerns for this year...The report also lists concerns regarding prescription drugs and pharmacies. The sixth concern on the list is "The Growing Threat of Substandard and Falsified Drugs."... Sub. Req’d

Big Pharma Fears Best-Selling Drugs in Crosshairs of US-EU Tariff Spat

(3/18, Maggie Fick, Reuters) ...In conversations with U.S. officials, the pharmaceutical industry argued that tariffs on the EU would increase drug costs and create access barriers for patients, endangering priorities outlined in President Donald Trump's health-related executive orders on drug pricing and increasing life expectancy of Americans, according to more than a half dozen pharma industry sources with direct knowledge of the discussions. Some are signalling a willingness to expand manufacturing in the United States, while pressing for tax breaks and regulatory changes that would make it easier to make that happen, according to three of the sources... Full

Trump Muddies EU Drug-Shortage Plan

(3/17, Kelly Hooper and Chelsea Cirruzzo, Politico) ...On the ground: Publicly, the U.S. generics lobby is engaging with the Trump administration while also educating policymakers about feasible domestic manufacturing options. Some capacity already exists, but companies without U.S. operations would have to decide whether to pass costs on to patients or prioritize other markets, which could further constrain supply. Consumers can wait out trade-related price increases in markets like automobiles, said John Murphy, president and CEO of the Association of Accessible Medicines, which represents generic drugmakers. "You can't do that with your cancer medicine," he said... Full

FTC Highlights New Concern Over ‘Pay-to-Delay' Deals That Determine When Generics Are Sold

(3/17, Ed Silverman, STAT+) ...In a recent report, the U.S. Federal Trade Commission released an update on patent settlements between brand-name and generic drug makers, but for the first time, mentioned a maneuver used by these companies that may raise a different type of antitrust concern... Sub. Req’d

Drug Pricing ‘Watchdog' Launches New Initiative With English, Canadian HTA Orgs

(3/17, Gabrielle Wanneh, Inside Health Policy) ...The U.S. nonprofit drug pricing watchdog ICER has joined forces with health technology assessment (HTA) groups in England and Canada to research new ways to evaluate the costs of prescription drugs, diagnostics and other health care interventions...Dan Ollendorf, chief scientific officer for ICER, told Inside Health Policy HEMA hopes to foster independent and critical assessment of new methods for assessing the value of health care interventions... Sub. Req’d

At Current Prices GLP-1s Aren't Cost-Effective, Limiting Access To Patients

(3/17, Joshua P. Cohen, Forbes) ...According to an analysis published last week in the Journal of the American Medical Association Health Forum, improved health outcomes notwithstanding, weight loss medications were not found to be cost-effective over a lifetime of projected use. The study's authors suggest that lack of affordability of medicines like Zepbound and Wegovy limits access for many who would benefit. In order to be cost-effective, the net price of tirzepatide (Zepbound) would need to decrease by 30%, while semaglutide's (Wegovy) price would have to drop by 82%. Net prices are negotiated between drug makers and insurers or pharmacy benefit managers, with list prices (before any discounts or rebates) serving as the starting point of negotiations... Full

Trump's HHS Defends Biden-Era Stance On 340B Rebate Models

(3/17, Nicole DeFeudis, Endpoints News) ...The comments, made in response to three legal challenges brought by Eli Lilly, Novartis and Bristol Myers Squibb, represent the Trump administration's first substantial defense of the Biden-era actions in court. HHS said it acted within its authority when it did not allow the three drugmakers to change the way they distribute 340B drug price discounts without prior approval from the agency. The proposed rebate models "would have upended the way the 340B Program has operated for more than thirty years," the agency said in a motion challenging lawsuits brought by the drugmakers... Full

GOP Hill Staffer Joins US FDA As Senior Advisor, But Competing With MAHA For Legislative Position

(3/17, Sarah Karlin-Smith, Pink Sheet) ...The US Food and Drug Administration's top legislative and policy staff position may go to a Grace Graham, a more traditional Republican than many in the Trump Administration, and an experienced Capitol Hill staffer. The hire likely would be positive for the pharmaceutical industry, and a contrast from many of Trump's Health and Human Services Department political appointees, who have unusually adversarial views towards the industry and its primary regulator... Global Sub. Full

Study: FDA Offers Flexibility, Expedited Review to First-in-Class Drugs More Often Than EMA

(3/17, Jeff Craven, Regulatory Focus) ...The US Food and Drug Administration (FDA) is more likely to offer regulatory flexibility and grant expedited review to first-in-class drugs than the European Medicines Agency (EMA), according to recent research published in Health Affairs..."Our findings underscore the need for regulators to carefully balance regulatory incentives with rigorous ongoing assessments of evidence supporting drug innovations," Han and Kesselheim concluded... Full

Column: Governor, Veto The Prescription Drug Board Bill

(3/17, Dr. Harry L. Gewanter, The Virginian-Pilot) ...I urge the governor once again to stand up for Virginia's patients and families. Veto HB1724 and champion comprehensive, effective reforms that will actually address prescription drug affordability. No policy is better than bad policy... Full

Editorial: Four Concrete Ways Massachusetts Can Lower Health Care Costs

(3/18, The Boston Globe) ...Requiring prior authorization makes sense for medications and treatments that are expensive or nonroutine but not for generic drugs commonly used to treat chronic disease... Full

Review Calls for Path to Global Harmonization of Biosimilar Development Regulations

(3/17, Skylar Jeremias, The Center for Biosimilars) ...Global harmonization of biosimilar regulations will enhance development and patient access, but overcoming technical and regulatory hurdles will be essential to achieving this goal, according to authors of a review published in Therapeutic Innovation & Regulatory Science... Full

Industry Slams UK Plan To ‘Demand A Third' Of Drug Company Revenue In Q2/Q3 2025

(3/17, Neena Brizmohun, Pink Sheet) ...The UK government is proposing to increase the statutory scheme headline payment percentage to 23.8% in 2025, 24.7% in 2026 and 26.4% in 2027. The rate is the amount of revenue that companies are required to hand back to government on their sales of branded medicines to the National Health Service. The proposed payment rate sets a new record for any such medicines sales payment scheme in the UK and shows that the UK medicines market "is fundamentally broken," says the Association of the British Pharmaceutical Industry... Global Sub. Full

Belgian Anti-Trust Authorities Probe Roche for Allegedly Delaying Biosimilars of Two Cancer Meds

(3/17, Ed Silverman, STAT+) ...In a brief statement, the Belgian Competition Authority alleged that Roche offered financial incentives to hospitals between 2017 and 2020 to deter them from considering competitive bids from other pharmaceutical companies that could supply similar medicines. The agency also maintained Roche disseminated "erroneous information" about using biosimilars in combination therapy... Sub. Req’d

Novo Nordisk Accepted Back into UK Pharma Group After ‘Sustained Improvements' Get Suspension Lifted

(3/17, Nick Paul Taylor, Fierce Pharma) ...Based on the audit reports and other evidence, the ABPI board ruled Novo has made the necessary progress "to ensure it is able to properly adhere to the strict industry standards" in the code of practice. Sebnem Avsar Tuna, general manager of Novo Nordisk U.K., said in a statement that the company has "considerably strengthened" its compliance processes so it can "be fully and effectively self-regulating."... Full

Indian Pharma Notes Proposed US Tariffs Present Both Challenges and Opportunities

(3/18, Nandita Vijayasimha, Pharmabiz.com) ...Harish K Jain, president, Federation of Pharmaceutical Entrepreneurs (FOPE) and director, Embiotic Labs, stated, "President Trump government has now proposed a Reciprocal Tariff. Currently, US levies zero percent tariff as against India's 10% tariff on imports. If reciprocal tariff is implemented, there will be pressure on margins for Indian pharma companies exporting to US since more often tariffs result into reduced transfer price. Generics are exported on thin margins which affects the bottomline growth of India's MSMEs (micro small medium enterprises). The reality is US healthcare is heavily dependent on Indian generics and there is no alternative to India since we have highest number of US FDA approved plants. Therefore, a pragmatic approach from both countries is much-desired."... Full

Russia Experiencing Antidepressants Sales Boom This Year

(3/17, The Pharma Letter) ...Sales of antidepressants in Russia during the period of January-February 2025 amounted to 2.8 billion roubles ($30 million) with a total of 3.2 million packages sold, which became a record figure for the country in the last five years, reports The Pharma Letter's local correspondent. According to the Russian analytical company DSM Group, that became by 30% higher than last year in value terms and by 15% in volume... Sub. Req’d

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