Wednesday, May 29, 2024

Fresenius Is Latest To File Denosumab With US FDA

(5/28, David Wallace, Generics Bulletin) ...With activity around denosumab biosimilars continuing to heat up, Fresenius Kabi has announced US FDA acceptance of its filing, while China's Henlius says the EMA is reviewing its own biosimilar submission...Other competitors on denosumab look likely to include Celltrion, which has previously disclosed an FDA filing for its CT-P41 candidate; Teva, which has a denosumab biosimilar in Phase III trials; and Samsung Bioepis, which late last year reported positive Phase I and Phase III trial results for its SB16 proposed denosumab biosimilar... Global Sub. Full

Krka Out Of The Blocks Solidly In Q1, With Russia Still Largest Market

(5/29, Dean Rudge, Generics Bulletin) ...Slovenian major Krka has enjoyed a solid start to 2024, welcoming 8% sales growth to €400.2m ($435m) for its prescription Pharmaceuticals segment in the first three months of the year and a group earnings before interest, tax, depreciation and amortization margin of 28.5%, "well above guidance."... Global Sub. Full

Merck Nears $1.3 Billion Deal for Eye-Drug Company EyeBio

(5/28, Jared S. Hopkins and Laura Cooper, The Wall Street Journal) ...Under the terms, Merck would pay the $1.3 billion in cash upfront to acquire the closely held biotech, according to people familiar with the matter. Merck could make an additional $1.7 billion in milestone payments for the company, which goes by the name EyeBio. The deal could be announced as early as Wednesday, the people said. Merck's venture arm was an investor in EyeBio... Sub. Req'd

Biocon Lines Up Another Liraglutide Deal, This Time In Korea

(5/28, David Wallace, Generics Bulletin) ...Biocon has notched up yet another partnership deal on liraglutide, striking an agreement with Korean firm Handok for its generic version of the chronic weight management treatment. Underlining the "vertically integrated, complex" nature of the product, Biocon said that under the agreement with Handok, the Indian firm will develop, manufacture and supply the synthetic liraglutide while Handok "will be responsible for obtaining regulatory approval and commercialization in the South Korean market."... Global Sub. Full

GLP-1 Prescriptions Reach All-Time High As Lilly and Novo Scramble to Keep Pace with Demand

(5/28, Anna Brown, Endpoints News) ...More US patients than ever are being prescribed GLP-1 weight loss medications each week, and biopharma experts have increased their annual sales forecasts of the drugs to more than $150 billion by 2030...Novo and Lilly have both faced supply constraints and drug shortages, with each rapidly boosting their manufacturing capacity. Just last week, Lilly said it was pouring $5.3 billion into its Indiana facility to boost active pharmaceutical ingredient production of its diabetes drug Mounjaro and weight loss drug Zepbound, both of which have doses in shortage in the US... Full

Amgen's Rare-Disease Treatment Biosimilar Bkemv Gets FDA Approval

(5/28, Ben Glickman, MarketWatch) ...The Food and Drug Administration said Tuesday that Bkemv, a monoclonal antibody, had been approved for treating paroxysmal nocturnal hemoglobinuria, a rare blood disorder, and atypical hemolytic uremic syndrome, another rare disease affecting kidneys and blood-clotting...The FDA said that Bkemv was the first interchangeable biosimilar to Soliris to treat the diseases... Full

Pfizer Files Flurry of Lawsuits Over Migraine Medication Patent

(5/28, Marianna Wharry, Law.com) ...Pfizer recently filed at least seven lawsuits in federal court seeking to enjoin multiple multinational pharmaceutical companies from selling a generic version of its medication, Nurtec, which is used to prevent and treat migraines...The named defendants include India-based Aurobindo Pharma, Msn Laboratories Private Ltd., Rubicon Research and Natco Pharma, Canada-based Apotex Inc., China-based Changzhou Pharmaceutical Factory and Israel-based Teva Pharmaceuticals Inc... Full

Generics Switching Program Saves Millions

(5/29, Karen Blum, Specialty Pharmacy Continuum) ...Pharmacists with the HighTouchRx program, operated by Prime Therapeutics/Magellan Rx Management, reviewed claims data from 807 patients taking brand-name MS drugs in 2023. Their outreach to providers resulted in 141 instances (18%) in which the provider switched the patient to a generic equivalent, at an estimated total savings of just over $10.3 million...Pharmacists reviewed data for 375 patients taking fingolimod (Gilenya, Novartis), 336 taking teriflunomide (Aubagio, Sanofi Genzyme), 42 taking dalfampridine (Ampyra, Acorda), 35 taking glatiramer acetate (Copaxone, Teva) and 19 taking dimethyl fumarate (Tecfidera, Biogen)... Full

New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching

(5/28, Skylar Jeremias, The Center For Biosimilars) ...Biosimilars are now widely accepted as alternatives to reference biologics in areas like immune-mediated diseases and oncology. By December 2023, more than 90 biosimilars were approved in the EU and more than 40 in the USA. Many molecules, including infliximab and adalimumab, have multiple approved biosimilars, making switching between them common...However, there remains skepticism globally about the safety of switching between biosimilars, particularly in gastroenterology and ophthalmology spaces... Full

Biologics Improve Outcomes in Patients With Overlapping COPD and Asthma

(5/28, Heidi Splete, Medscape) ...Biologic agents have been effective in reducing asthma exacerbations, and understanding their effectiveness in reducing COPD exacerbations in a real-world setting is important, said Arianne K. Baldomero, MD, assistant professor of medicine at Minneapolis VA Health Care System, Minneapolis, in an interview...The current study adds to the growing evidence supporting the use of biologics to reduce COPD exacerbations, Baldomero told Medscape Medical News. "I anticipate that we will soon begin using biologics to manage frequent exacerbations in patients with COPD," she said... Full

Study Finds SMART Combination Inhaler Regimen For Asthma Treatment Is Under Prescribed

(5/28, Gillian McGovern, Pharmacy Times) ...The National Asthma Education and Prevention Program and the Global Initiative for Asthma have updated their guidelines by 2021 to recommend that patients use SMART plus an inhaled corticosteroid (ICS)-formoterol to manage their moderate-to-severe persistent asthma. The SMART guidelines note that these inhalers can be used as both maintenance—twice per day—or rescue inhalers during asthma attacks... Full

Novo Blames US Health System After Sanders' Wegovy Criticism

(5/28, Naomi Kresge, Bloomberg) ...Novo Nordisk A/S said it retains about 60% of the list price of Ozempic and Wegovy in the US after rebates and fees paid to middlemen, as the debate heats up over the cost of its blockbuster diabetes and obesity medicines. Novo is prepared to work with lawmakers to address "systemic issues so that everyone who can benefit from its medicines is able to get them," the Danish drugmaker said in a letter Friday to Senator Bernie Sanders, who has been pressing Novo to lower the cost of Wegovy... Full

Novo Nordisk Blames Middlemen in U.S. Healthcare System for High Prices of Weight Loss Drugs Wegovy and Ozempic

(5/28, Louis Goss, MarketWatch) ...Novo Nordisk has blamed middlemen in the U.S. healthcare system for the high prices of its top-selling weight-loss drugs Wegovy and Ozempic, following the launch of an investigation into the drugs led by U.S. Senator Bernie Sanders...In a letter to Sanders on Friday, Novo Nordisk, which is now Europe's most valuable company, pointed to middlemen in the complex U.S. healthcare system but said it expects the net price of both Wegovy and Ozempic to fall under current market conditions... Sub. Req'd

Millions of Americans Need Drugs like Ozempic. Will it Bankrupt the Healthcare System?

(5/29, Karen Kaplan, Los Angeles Times) ...If manufacturers don't agree to reduce prices voluntarily, the federal government could take more forceful steps. The Inflation Reduction Act put a $35-a-month limit on what seniors with Medicare Part D plans need to pay for insulin. Congress could set a limit on GLP-1 drug prices too, though that would be "a last resort," said Lawrence Gostin, an authority on public health law at Georgetown University. Rationing the drugs is another way to keep spending in check, health economists say. High sticker prices have limited access to the drugs, often making income a determining factor in deciding who can take them and who must go without. But there are other ways to prioritize patients... Full

Medicare Plan to Verify Negotiated Drug Prices Spurs Unease

(5/29, Nyah Phengsitthy, Bloomberg Law) ...The Medicare system proposed by the Biden administration to verify negotiated drug prices reach eligible individuals is generating concerns about compliance and operational challenges for manufacturers and dispensing entities...The agency is asking the public to weigh in on the guidance by July 2, but feedback already is underscoring the slew of responsibilities handed to drugmakers and dispensing entities, such as pharmacies, to carry out the drug's maximum fair price... Sub. Req'd

Senators See Possible Conflicts of Interest in Health Care Pricing Tools

(5/28, Chris Hamby, The New York Times) ...The firm, MultiPlan, recommends what it says are fair payments for medical care, but the firm and the insurers can collect higher fees when payouts are lower. This business model could "result in an improper conflict of interest," the chairmen of the two committees, Ron Wyden of Oregon and Bernie Sanders of Vermont, wrote in a letter to the firm's chief executive that was released on Tuesday. The senators called on MultiPlan to meet with the committees' staffs to discuss an investigation last month by The New York Times that found the firm's pricing tools could leave patients with unexpectedly large bills when they see doctors outside their health plans' networks... Sub. Req'd

Bucshon Introduces New Bill To Clarify 340B Intent, Operations

(5/28, Gabrielle Wanneh, InsideHealthPolicy) ...Rep. Larry Bucshon (R-IN) on Tuesday (May 28) introduced the latest in a growing number of legislative efforts to refine statute around the 340B drug discount program. Known as the "340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act," the bill aims to clarify the law to ensure savings produced by the 340B program are used in a manner that better benefits patients... Sub. Req'd

Making Sense Out Of The IRA? – Good Luck To You!

(5/28, Martin Shimer, Lachman Consultants) ...Today's blog will focus on the IRA; this is not a discussion on Individual Retirement Accounts but rather the Inflation Reduction Act and the impact of this law on generic drug pricing... Full

Proposed FDA Rule Could Limit Pharmacy Compounding

(5/28, Ned Milenkovich, PharmD, JD, Pharmacy Times) ...The proposed rule prohibits compounding drugs listed on the DDC lists and also establishes a process for the FDA to review drugs for inclusion on a DDC list with stakeholder input. Clearly, the FDA is looking to ratchet up regulation of 503A and 503B compounding. The FDA has recently been very focused on inappropriate semaglutide compounding and has issued several warning letters as well as reminder letters to national associations such as the National Association of Boards of Pharmacy.4 Compounding pharmacies should be vigilant regarding FDA pronouncements and the proposed rule... Full

RI Could Soon Start Importing Prescription Drugs from Canada

(5/28, Kate Wilkinson, WPRI) ...The Rhode Island bill, sponsored by Senate Finance Committee Chairman Louis DiPalma, would allow Rhode Island to go directly to wholesale prescription drug manufacturers in Canada to buy prescription drugs at a reduced price..."The fact that identical drugs are so much cheaper across the border in Canada is a clear demonstration of the dysfunction in our healthcare system," DiPalma wrote in a statement Tuesday. "But until extensive and much-needed reform takes place, this legislation should ease the costs on many Rhode Islanders so they don't have to make these heartbreaking choices every month."... Full

IGBA's CEO Advisory Committee Advances Strategic Focus On Access to Medicines

(5/29, The Pharma Letter) ...Chief Executive Officers of the world's largest generic and biosimilar medicines companies recently met in Vienna, Austria, to provide strategic advice to the International Generic and Biosimilar Medicines Association. The generics and biosimilars sector, which supplies 70% to 90% of prescribed medicines around the world, is united in seeking to enable innovation and competition to improve patients' access to quality-assured, safe and cost-effective medicines... Sub. Req'd

IGBA's CEO Advisory Committee Advances Strategic Focus On Access to Medicines

(5/28, IGBA) ...Vinita Gupta, Chief Executive Officer of Lupin Limited, and Chair of IGBA's CEO Advisory Committee, noted "We are delighted to see the progress IGBA is making with the support of its members in advancing our key priorities to ensure access to affordable medicines." Adrian van den Hoven, Chair of the IGBA, added "The global industry CEOs bring leadership and drive to the IGBA mission of improving access to medicines for patients all around the world. With their commitment, the IGBA will deliver concrete projects to remove barriers to medicines access, including: a lack of regulatory alignment among countries and regions; the proliferation of patent thickets and; the absence of sustainable market policies to encourage rational use of generic and biosimilar medicines. The voice of the generic and biosimilar medicines industry is going to get a lot louder about barriers to medicines access."... Full

New Parliament Needs to Finalise Pharma Package, Begin Controversial Work On Health Determinants

(5/29, Catherine Feore, Euractiv) ...Much has been achieved, as summarised in the recent communication on the European Health Union. But two major areas will spill onto the desks of the next European Parliament: the pharma package and delayed proposals on health determinants of; tobacco, alcohol, and dietary proposals. The main dossier that remains pending is the Pharma Package... Full

EU Crunch Time For Myriad Drugs Marks A Busy May Meeting For CHMP

(5/28, Neena Brizmohun, Pink Sheet) ...The latest meeting of the European Medicines Agency's human medicines committee, the CHMP, is taking place this week. Decisions are expected for 13 drug marketing applications, there will be a number of oral explanation meetings, and activity is expected relating to a drug at the center of a case involving the European Commission's rejection of an EMA recommendation... Sub. Req'd

European Commission Approves 1 Billion Euros of Support for IPCEI

(5/28, The Pharma Letter) ...The European Commission today approved, under EU State aid rules, the first Important Project of Common European Interest (IPCEI) to support research, innovation and the first industrial deployment of healthcare products, as well as innovative production processes of pharmaceuticals. This IPCEI will notably contribute to the European Health Union's objectives by delivering innovations addressing diseases for which there are no satisfactory means of prevention or treatment and by increasing the EU's preparedness for emerging health threats... Sub. Req'd

Patients in England Ration Drugs As Supply Crisis Hits

(5/28, Ian Johnston and Laura Hughes, Financial Times) ...Drug shortages, defined as when a pharmacy or hospital orders a medicine but cannot receive it, are double the level of two and half years ago, according to official data collated by the British Generic Manufacturers Association, a trade body...The data, shared with the Financial Times, showed that 30 common drugs, from diabetes treatment metformin to painkillers such as paracetamol suppositories, have been in short supply for at least six months over the past two years. The analysis of figures from NHS England and the Department of Health and Social Care, the first of its kind by the BGMA, reveal the extent of drug scarcity across the country... Full

Biosimilars Offering a Great Opportunity in Growing Market: Kewal Handa

(5/29, The Economic Times) ...The prices have really been coming down in terms of raw materials and particularly in APIs. There is a lot of stability there. China are also now trying to align themselves to the global market requirements and they are also very keen to see that their factories start producing at the scale they were doing prior to COVID. "When I say sales and marketing opportunities, it is to look at omnichannel, look at digital, grow the market much faster than others, and penetrate as deep as possible," says Kewal Handa, Industry Expert... Full

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