Wednesday, September 18, 2024

J&J Confirms EU Stelara Biosimilars Are Imminent

(9/18, Dean Rudge, Generics Bulletin) ...Johnson & Johnson has confirmed that it continues to expect biosimilar competition to its multi-billion-dollar Stelara (ustekinumab) brand in Europe "later this month," with several approved biosimilar products waiting in the wings...In the US, J&J expects for Stelara "continued volume growth largely offset by price declines as we move towards biosimilar entry in 2025." Amgen's Wezlana (ustekinumab-auub), Alvotech's Selarsdi (ustekinumab-aekn) – which will be commercialized by Teva in the US – and the Samsung Bioepis-Sandoz Pyzchiva version have all been approved by the US Food and Drug Administration... Global Sub. Full

Novo Nordisk Sues Viatris' Mylan And Sun Pharma Over Wegovy Generics

(9/17, Adam Zamecnik, Generics Bulletin) ...Viatris' Mylan Pharmaceuticals and Sun Pharmaceuticals have become the latest targets in lawsuits filed by Novo Nordisk as part of its strategy to fend off the entry of Wegovy (semaglutide) generics into the lucrative US market...Some companies have also achieved milestones with the approval of different GLP-1 compounds in global markets. This includes Teva Pharmaceuticals, which managed to launch an authorized generic of Novo's type 2 diabetes treatment Victoza (liraglutide) in June 2024.... Global Sub. Full

Sandoz And Liquidia Triumph On Treprostinil

(9/18, David Wallace, Generics Bulletin) ...Sandoz and its generic Remodulin (treprostinil) partner Liquidia have welcomed a US court opinion that concluded the firms suffered losses of more than $137m as a result of interference by originator United Therapeutics in the launch of the generic treatment for pulmonary arterial hypertension...A Sandoz spokesperson told Generics Bulletin that the firm was "pleased with the court's opinion, which fully vindicates Sandoz efforts to provide PAH patients with an affordable generic treatment option for their disease."... Global Sub. Full

Coherus' Cancer Biosimilar Faces Supply Squeeze After Company's Contract Manufacturer Overextends Itself

(9/17, Fraiser Kansteiner, Fierce Pharma) ...Coherus warned that Udenyca supplies are likely to be "substantially depleted" by the middle of October, though the company expects production of the biosimilar will rev back up around the same time. In turn, supplies of Coherus' drug should gradually become available again starting in early November. Coherus stressed that the supply squeeze is solely related to labeling and packaging and does not concern the availability or supply of Udenyca's active pharmaceutical ingredient... Full

Pfizer Introduces a New Breakthrough for Acute Migraine Relief in the UAE, Aiming to Transform Patient Care

(9/18, Pfizer) ...Migraine, a debilitating neurological disorder, affects over a billion people globally. Today, Pfizer marks a significant milestone in its journey towards advancing healthcare in the UAE by introducing a groundbreaking nasal spray for acute migraine treatment demonstrating pain relief as early as 15 minutes, bringing hope and relief for adult patients with acute migraine... Full

FDA Approves Pavblu for Retinal Conditions

(9/17, Skylar Jeremias, The Center For Biosimilars) ...The FDA has approved Pavblu (aflibercept-ayyh), the fifth biosimilar referencing Eylea (aflibercept). The new product is approved for the treatment of retinal conditions, including neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy... Full

With Amped Up Manufacturing Effort, Sanofi and AZ Look to Avoid Beyfortus Shortfalls This Year

(9/17, Zoey Becker, Fierce Pharma) ...As this year's respiratory syncytial virus season approaches, Beyfortus makers Sanofi and AstraZeneca are making preparations to avoid last year's supply issue with a newly approved filling line. In all, the partners plan to provide enough supply to cover every eligible infant in the U.S... Full

Nationwide ADHD Medication Shortage is 'An Ongoing Problem' in Metro Detroit

(9/17, Peter Maxwell, WXYZ) ...As demand surges, local pharmacies are feeling the pressure, and solutions remain elusive. Earlier this month, the Drug Enforcement Administration approved an increase in the production of Vyvanse and its generic equivalents. However, despite this positive development, the shortage persists, impacting local pharmacies like i Pharmacy in Livonia. "It's an ongoing problem," pharmacist Rudy Najm said, highlighting the two-year struggle to maintain adequate supplies... Full

Aurobindo Pharma Arm Gets USFDA Nod with EIR for Andhra Pradesh Facility

(9/18, CNBC TV 18) ...Aurobindo Pharma Ltd announced on Wednesday, September 18, that its step-down subsidiary, Eugia Sterlite Private Ltd, has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration... Full

GLP-1 Pills Are Coming, and They Could Revolutionize Weight-Loss Treatment

(9/17, Meg Tirrell, CNN) ...At least a dozen similar experimental weight-loss drugs designed to be taken as pills are working their way through clinical trials, with the most advanced now in the third and final stage of testing. They're likely to "drastically change the landscape for weight management in several ways," said Dr. Jody Dushay, an assistant professor of medicine at Harvard Medical School and an attending physician in endocrinology at Beth Israel Deaconess Medical Center, who prescribes weight-loss medications... Full

NPR Exclusive: U.S. Overdose Deaths Plummet, Saving Thousands of Lives

(9/18, Brian Mann, NPR) ...National surveys compiled by the Centers for Disease Control and Prevention already show an unprecedented decline in drug deaths of roughly 10.6 percent. That's a huge reversal from recent years when fatal overdoses regularly increased by double-digit percentages. Some researchers believe the data will show an even larger decline in drug deaths when federal surveys are updated to reflect improvements being seen at the state level, especially in the eastern U.S... Full

US Senator Sanders Says Generic Drugmakers Could Sell Ozempic for Less Than $100/Month

(9/17, Mariam Sunny, Reuters) ...U.S. Senator Bernie Sanders said on Tuesday he received confirmation from major generic pharmaceutical companies that they could sell copycat versions of Novo Nordisk's diabetes drug Ozempic for less than $100 a month... Full

Bernie Sanders Says Ozempic Can Be Produced for Less Than $100 a Month

(9/17, Berkeley Lovelace Jr., NBC News) ...Sanders made the remark at an expert roundtable event on Capitol Hill, which served as a preview to Novo Nordisk CEO Lars Fruergaard Jørgensen's testifying before the Senate Health, Education, Labor and Pensions Committee next week...During Tuesday's roundtable, Sanders said his recent conversations with generic drugmakers revealed that Novo Nordisk's pricing is "nothing less than excess corporate greed."... Full

Novo Says Ozempic ‘Very Likely' Target for Next US Price Cut

(9/18, Gerry Smith and Madison Muller, Bloomberg) ..."It is very likely that Ozempic will be part of negotiations in the coming round, and we're ready for that," Ulrich Otte, senior vice president of finance & operations for Novo Nordisk, said Tuesday at the Cantor Global Healthcare Conference in New York...Novo Chief Executive Officer Lars Fruergaard Jørgensen will testify before a Senate committee led by Senator Bernie Sanders about the drugs' prices next week... Sub. Req’d

Lawmakers, Policy Experts Spar Over the Inflation Reduction Act in Senate Hearing

(9/17, Noah Tong, Fierce Healthcare) ...IRA supporters defended President Joe Biden's term-defining legislation because of its ability to reduce price increases for specialty drugs, cap out-of-pocket prescription costs, allow the government to negotiate with pharma companies and lower the nation's uninsurance rate. They said the law is a good first step that needs further refinement. IRA skeptics said the law has unintended side effects that will incentivize drug production practices that are less innovative... Full

Express Scripts Sues FTC Over a ‘Biased' Report About Pharmacy Benefit Managers

(9/17, Ed Silverman, STAT Plus) ...Express Scripts, one of the largest pharmacy benefit managers in the U.S., filed a lawsuit on Tuesday demanding that a recent Federal Trade Commission report accusing industry middlemen of raising drug prices be retracted... Sub. Req’d

Cigna Group Sues FTC Over Interim PBM Report, Former FTC Counsel Argues Suit Is Weak

(9/17, Maaisha Osman, InsideHealthPolicy) ...Cigna Group's Express Scripts has sued the Federal Trade Commission (FTC) alleging its interim pharmacy benefit manager report from July contains false, unsupported conclusions and is rooted in FTC Chair Lina Khan's bias against the industry, and is demanding the report's retraction. FTC tells Inside Health Policy it stands by its report, and a former FTC general counsel argues the lawsuit is weak and seems more an attempt to pressure commissioners who raised concerns about the report to get it retracted... Sub. Req’d

PCMA Statement On Suit Against The FTC

(9/17, PCMA) ...Pharmaceutical Care Management Association (PCMA) President and CEO JC Scott issued the following statement today: "The industry trade association representing America's pharmacy benefit companies reiterates its position that, to date, the Federal Trade Commission (FTC) has fallen far short of providing a definitive, fact-based assessment of pharmacy benefit managers (PBMs) or the prescription drug market."... Full

The Impact of the Inflation Reduction Act On the Economic Lifecycle of a Pharmaceutical Brand

(9/17, Luke Greenwalt, IQVIA) ...Altering the economic lifespan of a product such as Keytruda could slow research, directly delay patient access to medicine, and have a global health impact... Full

AEI To Senators: CMS Could Fix Part D Formulary Issues, But May Need Pressure

(9/17, Sigi Ris, InsideHealthPolicy) ...A health policy expert told senators on the Finance Committee Tuesday (Sept. 17) that CMS could take several measures to fix formulary issues many say are causing beneficiaries to see increased premiums and restricted access to medications, but suggested Congress might need to pressure the agency to do so. The Alliance for Aging Research and Manatt also recently suggested CMS has the tools to fix the problems... Sub. Req’d

Telehealth Prescribing Mess Could Reach Congress

(9/18, Maya Goldman, Axios) ...Health care providers and telehealth vendors are pressing Congress to break an impasse over the virtual prescribing of controlled substances that could affect access to drugs like Adderall, along with medical marijuana and testosterone... Full

U.S. Agency Threatens J&J with Sanctions if it Switches Payments to 340B Hospitals

(9/17, Ed Silverman, STAT Plus) ...In a letter sent on Tuesday, the U.S. Health Resources and Services Administration maintained that a J&J plan to issue rebates for two widely prescribed medicines instead of offering discounted prices would violate federal law. The agency argued the planned move is unlawful because it would require the hospitals to purchase the medicines at prices exceeding what the discount program permits... Sub. Req’d

J&J Warned to Scrap Drug Rebate Planned in Lieu of Discounts

(9/17, Nyah Phengsitthy, Bloomberg Law) ...Johnson & Johnson's proposal to end upfront discounts for drugs purchased by hospitals treating low-income and uninsured patients may result in terminated pricing agreements or sanctions, according to a letter from a federal health agency...The proposed model is slated to go into effect Oct. 15. A J&J spokesperson on Tuesday said the company will "continue to constructively engage with HRSA on the 340B program to identify solutions that help modernize the program for a more sustainable future."... Sub. Req’d

Generics, Patient Groups Train Ire On Patent Bills

(9/17, Lauren Gardner and David Lim, Politico) ...The Senate Judiciary Committee is scheduled to mark up two bipartisan bills Thursday that affordable-drug proponents and generics makers say would make it easier for major pharma companies to game the patent system in favor of their products... Full

Drugmakers Rely On ‘Use Codes' to Vastly Expand the Nature of Their Patent Claims, STAT Analysis Shows

(9/18, Ed Silverman and Michael Nolan, STAT Plus) ...Amid debate over potential abuse of the U.S. patent system by the pharmaceutical industry, moves by some drugmakers to expand their patent claims appear to be delaying the arrival of lower-cost generic medicines to the marketplace, according to a STAT analysis... Sub. Req’d

Sens. Rick Scott, Elizabeth Warren Lead Colleagues to Warn of Risks to National Security, Military Readiness from Reliance On Foreign Pharmaceuticals

(9/17, Florida's U.S. Senator Rick Scott) ...This decision poses significant risks to the military's drug supply chain, which is already over-reliant on foreign-sourced pharmaceuticals. DoD's interim report on Pharmaceutical Supply Chain Risks revealed that "54% of the DoD pharmaceutical supply chain is considered either high or very high risk, with dependency on non-[TAA] compliant suppliers, sourcing from China and India, or unknown."... Full

Colorado, Maryland Drug Price Boards Inch Closer to Payment Caps

(9/18, Celine Castronuovo, Bloomberg Law) ...The Colorado Prescription Drug Affordability Board is scheduled to meet in October as it considers how to establish limits on how much health plans in the state can pay for three anti-inflammatory treatments: Amgen Inc.‘s Enbrel, Johnson & Johnson‘s Stelara, and Novartis AG‘s Cosentyx... Full

Oregon Lawmakers Eye Pharmacy Benefit Manager Regulation

(9/17, Meira Gebel, Axios) ...Some Oregon lawmakers say they plan to propose regulations on pharmacy benefit managers, following the lead of Congress and other states' Legislatures...Supporters of the regulations say the goal is to ensure the state's dwindling independent pharmacies have a better chance to stay in business... Full

Small Pharmacies Push California Gov. Newsom to Sign Bill to Rein in Drug Intermediaries

(9/17, Ron Leuty, San Francisco Business Times) ...After five years fighting prescription benefit managers, Maria Lopez is sure of one thing: Small specialty pharmacies like the one she leads have barely stood a chance against the drug middlemen that control who gets what drugs from which pharmacies. Now with a California bill requiring prescription drug managers, or PBMs, to be licensed and to stop a practice known as "patient steering," Lopez said Mission Wellness Pharmacy and other independent pharmacies are nearing a key victory if Gov. Gavin Newsom signs the bill this month... Sub. Req’d

EU Pharma Calls For Better Metrics On True Impact Of Clinical Trial Disclosure

(9/17, Vibha Sharma, Pink Sheet) ...European pharmaceutical industry group, EFPIA, says it is committed to supporting clinical trial transparency, but wants greater clarity on how disclosed data are effectively contributing to public health improvements so that investments can be prioritized in areas providing the greatest benefit... Sub. Req’d

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