Tuesday, November 26, 2024

Sandoz Builds Its Biologics Portfolio For Europe, Not US, Says CEO Saynor

(11/26, Urte Fultinaviciute, Generics Bulletin) ..."We define our biologic portfolio for Europe. We don't define it for the US," is how Sandoz's CEO Richard Saynor described the firm's relationship and business model for the two regions. Europe's better clarity around launch times and market access is what makes the region a priority for Sandoz, whereas the US has an element of uncertainty around patents and intellectual property, said Saynor at the recent Jefferies Global Healthcare Conference in London in late November... Global Sub. Full

Kesimpta Presents A Mammoth Opportunity But Novartis Isn't Seeing Rivals – Yet

(11/25, Dean Rudge, Generics Bulletin) ...Sandoz has spoken repeatedly about the beneficial lack of any other biosimilar competition to Tysabri (natalizumab), but it's another blockbuster in the biologic multiple sclerosis space that seems to be going under the radar for biosimilar sponsors. During Novartis' recent Meet the Management investor event, the Swiss originator highlighted that it was not anticipating any biosimilar competition to its Kesimpta (ofatumumab) CD20 monoclonal antibody potentially beyond patent expiry...In the MS space, small-molecule brands including Tecfidera (dimethyl fumarate) and Gilenya (fingolimod) have met generic competition in the US in recent years, while Teva's Copaxone (glatiramer acetate) injectable fell to generic competition more than a decade ago... Global Sub. Full

Celltrion's Remsima On Course to Become Korea's 1st Blockbuster Drug

(11/25, Jeong Min Nam, The Korea Economic Daily) ...Celltrion Inc.'s Remsima, the world's first biosimilar monoclonal antibody, is on track to exceed 1 trillion won ($713 million) in sales this year to become the first Korean drug to do so...Remsima SC, launched in 2020, is the world's first SC infliximab medication referencing Remicade. Celltrion aims to bring its total biosimilar offerings to 11 by 2025 and 22 by 2030, a significant increase from its current roster of six biosimilars... Full

AstraZeneca Pharma Gains CDSCO Approval to Import Cancer Drug Lynparza

(11/25, CNBC TV-18) ...AstraZeneca Pharma India Ltd has received approval from the Central Drugs Standard Control Organisation to import and distribute the cancer treatment drug Olaparib, branded as Lynparza, in India. The approval allows the company to import the drug in film-coated tablet form in dosages of 100 mg and 150 mg for sale and distribution in the country... Full

Roche to Acquire Cell Therapy Maker Poseida Therapeutics in $1.5 Billion Deal

(11/26, Dave Graham and Ludwig Burger, Reuters) ...Roche will pay $9 per share in cash and stockholders will also receive a non-tradeable contingent value right for up to $4 per share based on achievements, the companies said in a statement on Tuesday, taking the deal value to up to around $1.5 billion. It is expected to close in the first quarter of 2025... Full

India's Lupin Recalls More Than 600k Bottles of Blood Pressure Med Over Questionable API Source

(11/25, Joseph Keenan, Fierce Pharma) ...Indian drugmaker Lupin is recalling more than 600,000 bottles of the high blood pressure and heart failure drug ramipril due to the presence of an active pharmaceutical ingredient that came from an unapproved vendor...That action was taken after the company received a warning letter from the FDA in the wake of an inspection that found the facility failed to establish proper cleaning protocols. The company also failed to set up in-process samples and controls, and its own investigations into the plant's deficiencies were lacking, the FDA found... Full

Inside the Telehealth-Fueled GLP-1 Alternative Market

(11/26, Alex Hogan, STAT) ...Meeting that huge demand has been challenging. The name-brand medications are very expensive and not always covered by insurance. Even with coverage, consistent shortages of these drugs have plagued the market. But there is a loophole filling this market gap. When name-brand drugs are in shortage, the FDA temporarily allows compounding pharmacies to make generic versions of these medicines. These specialized pharmacies, which typically make customized drugs for individual patient needs, have become a popular alternative for patients seeking GLP-1 prescriptions... Full

CVS Caremark Makes Changes in Diabetes Coverage for 2025

(11/25, Denis Myshko, Formulary Watch) ...The PBM, which is one of the "big 3" in the industry that manage the vast majority of prescriptions in the U.S., has removed several therapies to treat patients with diabetes in favor of newer products and generics, based on a review of the it's Performance Drug List – Standard Control for January 2025...CVS Caremark is removing Novo Nordisk's Victoza (liraglutide), one of the much-talked about glucagon-like peptide 1 (GLP-1) drugs, and instead listing a generic version that was approved this year. Teva launched the first generic of Victoza in June 2024 with a WAC price of $469.60 for the two-pen package and $704.40 for the three-pen package. Victoza's list price is $543.51 for two pens and $815.27 for three pens. CVS Caremark is also suggesting that patients consider several other GLP-1s instead of Victoza, including Mounjaro (tirzepatide), Ozempic (semaglutide), Rybelsus (semaglutide) and Trulicity (dulaglutide)... Full

The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars

(11/25, Skylar Jeremias, The Center For Biosimilars) ...Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars. Originator biologic companies in the US may respond aggressively to biosimilar competition by significantly increasing rebates—by as much as 89%—and reducing net prices by up to 51%, demonstrating a strong effort to retain market share, according to a recent study... Full

Biden Proposes Requiring Medicare, Medicaid to Cover Weight Loss Drugs

(11/26, Evan Bush, NBC News) ...The Biden administration plans to require Medicare and Medicaid to offer coverage of weight loss medications for patients seeking to treat obesity. The new rule, which was proposed by the administration on Tuesday, would dramatically expand access to anti-obesity medications like Wegovy, Ozempic and Mounjaro... Full

Biden Proposes Medicare and Medicaid Coverage of Obesity Drugs

(11/26, Madison Muller, Bloomberg) ...The proposal would slash out-of-pocket costs by as much as 95% for the drugs that can carry a price tag of $1,000 a month, according to a White House official. Medicare, which provides coverage to about 52 million older Americans, currently doesn't pay for related drugs like Wegovy and Zepbound for obesity. Just 13 state Medicaid programs cover the the blockbuster weight-loss medications. The move is a victory for drugmakers Novo and Lilly, which are just emerging from shortages that have curtailed access to the brand-name medicines for the past two years... Full

US FDA Commissioner Nominee Not ‘Pro-Industry Choice,' GLP-1 Compounding Could Be First Clash

(11/26, Sarah Karlin-Smith, Pink Sheet) ...Donald Trump's announcement of his intent to nominate Martin Makary for FDA commissioner could set up a clash between the agency and industry over compounding policies, particularly related to GLP-1s. The scope of Makary's financial divestments and recusal may impact whether compounding is a make-or-break issue for pharma and the nomination... Global Sub. Full

How Did Trump's FDA Pick Land? Biotech Stocks Are Up, And Executives Are (Mostly) Relieved

(11/25, Max Bayer, Endpoints News) ...A biopharma executive granted anonymity to speak freely said the decision "could be much worse." The executive said that they thought the choice of Makary significantly cut the chance that "crazy stuff" would happen. Another executive said that they believed "he's a science-first person and the industry will be able to work productively with him on medicines that matter." The executive said they thought he would likely take a closer look at widely-used treatments where he felt the evidence could be stronger... Full

Medicare Pays Wildly Different Prices for the Same Drug

(11/26, Jared S. Hopkins and Josh Ulick, The Wall Street Journal) ...Medicare is paying wildly different prices for the same drug, even for people insured under the same plan. As a result, people covered by Medicare can be on the hook for thousands of dollars in additional out-of-pocket costs depending on where they live and which drug plan they choose...Not only is it confusing and costly for seniors, the wide range of drug prices costs Medicare. The program, which farms out drug-price negotiations to the firms, pays tens of millions of dollars extra for prescriptions... Sub. Req’d

Why Some Seniors Are Paying Different Prices for the Same Drug Under Medicare

(11/26, The Wall Street Journal) ...The price Medicare pays for a single medicine can range by thousands of dollars, even for people enrolled in the same plan. Wall Street Journal health and science reporter Jared S. Hopkins joins host J.R. Whalen to discuss why this happens... Full

‘Patent Thicketing' Keeps Prescriptions Unaffordable

(11/25, James Gelfand, DC Journal) ...Biosimilars and generic drugs could help patients, employers and taxpayers realize lower costs, but only if we reform the patent system so those drugs have a viable chance of getting to market. The potential for savings is significant. Generic and biosimilar drugs represent 90 percent of all U.S. prescriptions but account for only 13 percent of overall drug spending. Inaction is a decision that America literally cannot afford... Full

What Other Countries Could Teach the U.S. About Bringing Down Drug Prices

(11/25, Aimee Levitt, Stanford Business) ...To see just how much the U.S. could learn, [Iselin Dahlen Syversen, Head of the Norwegian Government Department] and [Kevin Schulman, Health Economist at Stanford] teamed up with two colleagues at Harvard Medical School, Aaron S. Kesselheim and William B. Feldman, to do a comparative study of drug price negotiations in the U.S., Norway, and six other countries in Europe and North America...Their findings detail a stark difference in approach. In other countries, the government negotiates with pharmaceutical companies directly to set a single market price. In the U.S., things are not so simple... Full

Trump Says He Will Impose New Tariffs On Canada, Mexico and China On First Day

(11/25, Sylvan Lane, The Hill) ...In a series of posts on Truth Social, the president-elect said he would enact tariffs of 25 percent on all Canadian and Mexican goods, and add another 10 percent tariff to all Chinese goods — many of which are already under tariffs imposed by Trump during his first term. Trump said the new tariffs are meant to push all three nations to take stronger efforts to bolster border security and crack down on fentanyl exports to the U.S... Full

ASPR Announces New DPA Funding For API Supply Chain

(11/25, Sigi Ris, InsideHealthPolicy) ...The Administration Strategic Preparedness and Response (ASPR) announced two new investments in domestic production of active pharmaceutical ingredients (API) in the United States under the Defense Production Act Monday (Nov. 25), which it says will aim to rebuild and protect the U.S. public health supply chain as an essential part of national defense... Sub. Req’d

Big Pharma's Three Musketeers

(11/25, Peter J. Pitts, RealClearHealth) ...Could that be momentum? First it was Johnson & Johnson, then Eli Lilly, now Sanofi and it can be summed up in three little words - Trust but verify. These Three Musketeers suggest a new reimbursement dynamic -- hospitals will receive 340B prices only after submitting certain medical, purchase and dispensing data. Not everyone thinks it's a good idea. Not everyone is paying attention. Attention must be paid... Full

Amid Trump Cost-Cutting Plans, GAO Warns FDA Needs To Invest In Inspection Workforce

(11/25, Jessica Karins, InsideHealthPolicy) ...Even as the next presidential administration plans massive spending and staffing reductions for federal health agencies, a new report from the Government Accountability Office (GAO) warns FDA's ability to monitor drug safety will be harmed if the agency doesn't take steps to retain facility inspectors it's previously written off as too costly, like reducing travel time and improving work-life balance... Sub. Req’d

Minnesota 340B Revenue Driven by Hospitals and High-Priced Drugs, First State Report Says

(11/25, Zachary Brennan, Endpoints News) ...The first year of Minnesota data show how hospitals and healthcare providers collectively earned net 340B revenue of $630 million in 2023, according to a new report released Monday on data from 90% of 204 facilities reporting. Acute care hospitals pulled in 80% of the 340B revenue, according to the data. But those numbers may be misleading. Based on national data, the state health department "believes this figure may represent as little as half of the actual total 340B revenue" in Minnesota... Full

New EU Fee Regulation: Smaller Firms & Orphan Drugs Will Still Benefit From Full Reductions

(11/26, Eliza Slawther, Pink Sheet) ...The European Medicines Agency's new fee regulation will apply from January 2025, introducing higher annual fees and marketing authorization fees for applicants. Micro-sized firms and SMEs that manufacture orphan drugs will continue to benefit from full reductions in annual fees, the EMA has confirmed in new guidance. Two further guidance documents are expected, one of which will set out fees related to marketing authorization application deferrals, for which new charges will be introduced... Global Sub. Full

EU Clinical Trial Rules Not Competitive with US and Asia, Says Dutch Pharma Association

(11/26, Christoph Schwaiger, Euractiv) ...A recent report by research service provider IQVIA, commissioned by EFPIA and Vaccines Europe, showed that while the European Economic Area's global share of commercial trials has reduced from 18% in 2018 to 12% in 2023, China has doubled its number of commercial trials since 2018 and now accounts for an 18% share of global commercial clinical trials. The report suggests that Europe's diminishing attractiveness for clinical research can be attributed to less favourable regulatory and funding environments... Full

UK MHRA Calls On Pharma To Embrace RWD Early

(11/26, Anabel Costa-Ferreira, Pink Sheet) ...The UK Medicines and Healthcare products Regulatory Agency is encouraging companies to "spread the word, have ideas and come talk" about their real-world evidence strategies, with the aim of moving these discussions to earlier stages of the drug development cycle... Global Sub. Full

Moderna's Missteps Spotlight PMCPA's Role in Upholding Pharma Ethics

(11/26, Ben Hargreaves, Pharma Phorum) ...The pharmaceutical industry operates under a complex regulatory landscape, balancing government oversight with self-imposed standards. Ben Hargreaves finds that the ABPI recently updated its code of practice and its self-regulatory division took action against Moderna... Full

Indian Bio-Pharma Needs to Shore-Up its IP Wealth with Advanced Research & Innovation: Dr Jitendra Kumar

(11/26, Pharmabiz.com) ...Indian bio-pharma sector needs to invest in advanced research and development to sustain its competitive edge and capitalize on new opportunities in the global market. The industry needs to focus on enhancing their intellectual property (IP) wealth, said Dr Jitendra Kumar, managing director, DBT-BIRAC... Full

Why Generic Medicine Is The Key To Sustainable Healthcare In Developing Nations?

(11/25, Dr. Sujit Paul, BW Healthcare World) ...India produces 20% of the world's supply of generic medications by volume, making it the third-largest producer in the world...There is no denying generic medicine's contribution to India's sustainable healthcare paradigm. By prioritising quality, affordability, and accessibility, India may lessen the burden of healthcare and establish a system that caters to all socioeconomic groups. India is headed toward universal health care with steady government support, more knowledge, and bolstered confidence in generics... Full

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