Friday, September 19, 2025

The Administration Risks Drug Shortages That Will Cost Patients Dearly

(9/18, Wayne Winegarden, Forbes) ...Uneconomical pricing in other countries is a problem, and the U.S. drug pricing system is fundamentally flawed. The U.S. should address the uneconomical prices in other countries through trade negotiations...Tariffs and the MFN policy are not effective responses to these problems, however. Implementing either policy would harm patients and cause distressing drug shortages and access issues. If the Administration is truly committed to helping patients, it will jettison these destructive policies... Sub. Req’d

Most Favored Nation Pricing Model Could Fail Patients, New Brief Finds

(9/18, Alliance for Patient Access) ...The Most Favored Nation model intended to reduce drug prices in the U.S. could negatively impact patient access, according to a new Apteka policy brief commissioned by the Alliance for Patient Access...According to the analysis, Most Favored Nations may: Trigger new utilization management restrictions, such as tighter formularies, prior authorization or step therapy requirements. Limit future treatment options by discouraging investment in biosimilars and slowing pharmaceutical innovation. Overlook fundamental differences between the U.S. health care system and those abroad, leading to unintended consequences... Full

Most Favored Nation Drug Pricing: Aiming At Pharma's Achilles Heel

(9/18, Ian D. Spatz, Health Affairs) ...While economists can debate the magnitude of international drug price differences, no one seriously denies that American drug prices – list prices and those actually paid – are significantly higher in the US compared to prices in European countries and other developed nations including Canada, Japan, South Korea, Australia, and New Zealand. As President Trump takes aim at these price differences through his Most Favored Nation executive order, this article looks at how the differences occur and the issues they raise... Full

Tariffs: Added Strain On The US Health Care System

(9/18, Ahmad M. Hider Dawn O'Connell Nicholas L. Berlin, Health Affairs) ...Tariffs can be tools of economic strategy, but when applied indiscriminately to critical sectors such as health care, their unintended consequences ripple far beyond financial markets. As we weigh the potential benefits of reshoring production or asserting trade dominance, we should also consider the costs: increased costs for the hospitals and health care systems providing care to patients, critical hospital closures and further consolidation, and financial toxicity for patients. Tariff policy, like any instrument of governance, must be wielded with nuance and an unwavering commitment to public well-being. Anything less risks transforming economic policy into a vector of harm, outweighing the broader benefits for Americans... Full

Trump Administration's New Global Health Aid Strategy Focuses On Bilateral Deals with Countries

(9/18, Ali Swenson, Associated Press) ...The State Department on Thursday announced it will refocus its foreign health assistance strategy around multiyear bilateral deals with recipient countries, making aid dependent on negotiations that officials say will help reduce waste and advance American priorities... Full

Hospitals, Pharma Clash Over Burdens Under HHS Drug Rebate Plan

(9/19, Nyah Phengsitthy, Bloomberg Law) ...The risks prompted health providers—and even a bipartisan group of lawmakers—to urge HHS to scrap the pilot. Drugmakers, meanwhile, are asking the government to expand the plan, as the proposal only limits participants to manufacturers with medicines selected for the first round of the Medicare Drug Price Negotiation Program. The model is a "fundamental, massive shift," said Jeffrey Davis, a member at Bass, Berry & Sims PLC, specializing in 340B... Sub. Req’d

AAM Applauds Q1/Q2 House Bill Markup

(9/18, AAM) ..."AAM thanks Representatives Dunn and Mullin for reintroducing this legislation and the House E&C Committee for markup of the bill this week," said John Murphy III, President and CEO of the Association for Accessible Medicines. "This bipartisan issue expedites process efficiencies for the industry and at FDA for generic medicines submissions, which will enhance patient access to lower-cost medicine. When generic medicines become available, they immediately bring lower prices for lifesaving and lifechanging medications. AAM looks forward to continuing working with the bill sponsors and the committee to move this legislation forward."... Full

Repurposed Drugs Is a Promising Path

(9/18, Stephen M. Smith, RealClearHealth) ...We need to rethink how we as a nation fund the development of new medicines. Yes, we need research-based pharma companies investing in the clinical trial process to make new discoveries. But clinical observation is essential and must return to prominence... Full

Dose of Reality: Big Pharma's Quick Delisting of More Than 40 Sham Patents Highlights Scale of Patent Thickets on Top Money-Makers

(9/18, Campaign for Sustainable Rx Pricing) ...Among the delistings, were patents on blockbuster GLP-1 drugs—like Novo Nordisk's Ozempic and Saxenda and AstraZeneca's Bydureon—and COPD inhalers like AstraZeneca's Symbicort, GSK's Anoro Ellipta and Incruse Ellipta and Boehringer Ingelheim's Striverdi Respimat. On paper, the Orange Book is meant to serve as a resource listing all the patents that brand name drug manufacturers have secured for FDA-approved products. However, in practice, brand name drug companies effectively game the Orange Book to make it more challenging for potential competitors to introduce alternative products to brand name drugs... Full

Democrats See Health Care as the Reason They'll Avoid Shutdown Blame

(9/19, Alexander Bolton, The Hill) ...The confidence is reflected in the fact that Senate Democratic leaders aren't budging from their position that they won't vote for a clean seven-week continuing resolution to fund the government past Sept. 30 if it passes the House. Doing so risks getting blamed for the shutdown, but Democratic leadership feels confident it will win the public debate if Democrats are successful in arguing the shutdown is about protecting the health care of millions of Americans. Democrats say health insurance rates are going to soar because Republicans are refusing to extend the enhanced health insurance premium subsidies under the Affordable Care Act, which are due to expire at the end of this year... Full

Rick Scott Presses for Domestic Generic Drug Production

(9/18, Megan O. Neill, The Floridian) ......"The FDA has got to be clear. This is what our inspection program is. This is what's never been inspected. These drugs, that plant hasn't been inspected in 10 years," Scott said in an interview with The Floridian... Full

Celltrion Targets 22 Biosimilars in Bone, Eye, Skin Diseases

(9/19, Kwak Soo-keun, The Chosun Daily) ...Celltrion is accelerating its global market strategy by strengthening its existing portfolio centered on autoimmune disease and anticancer treatments while expanding its product lineup into new therapeutic areas such as bone, eye, and skin diseases. As the aging population increases demand for treatments and patients with related conditions, the market size for Celltrion's new biosimilars is expected to grow significantly. The company stated, "We anticipate that future sales growth will gain further momentum," adding, "We will continue to expand the proportion of new biosimilar products to secure long-term growth drivers."... Full

Celltrion Starts Europe Launch of Omlyclo, The 1st Xolair Biosimilar

(9/19, Kim Ji-hye, Korea Biomedical Review) ...The product is the first omalizumab biosimilar cleared in the EU, with the European Commission granting approval in May 2024 for allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps. Additional launches are planned in the fourth quarter in major markets including France, Germany, Italy, Spain and the U.K...Competition is at mixed stages...Alvotech, with Kashiv and Advanz, reported positive confirmatory data for AVT23 and said the U.K. regulator has accepted a marketing application, with a European filing expected this year. Teva's TEV-45779 has completed phase 3 in 2024, with no U.S. or EU filing disclosed... Full

Health Canada Approves Celltrion's Stoboclo® and Osenvelt®(CT-P41), Denosumab Biosimilars for the Treatment of All Indications Approved for the Reference Products, Prolia® and Xgeva®, Respectively

(9/18, Celltrion) ...The approval is based on the totality of evidence including results from a Phase III clinical trial in postmenopausal women with osteoporosis (PMO). Celltrion's biosimilar portfolio continues to grow, expanding treatment options to reach more patients in Canada... Full

European Commission (EC) Approves Henlius and Organon's BILDYOS® (Denosumab) and BILPREVDA® (Denosumab), Biosimilars to PROLIA (Denosumab) and XGEVA (Denosumab), Respectively

(9/19, Shanghai Henlius Biotech, Inc., Organon) ...Shanghai Henlius Biotech, Inc., and Organon today announced the European Commission (EC) has granted marketing authorization for BILDYOS® (denosumab) injection 60 mg/mL and BILPREVDA® (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products... Full

Aurobindo Pharma Arm Reports Positive Phase 3 Trial Results for Osteoporosis Drug

(9/19, Moneycontrol) ...The study, conducted across 40 sites in five European countries on 446 postmenopausal women, met all clinical endpoints, showing no clinically meaningful differences between the biosimilar and the reference product. Dr Arpit Prajapati, Head of Clinical Sciences at CuraTeQ, said the trial evaluated the biosimilar's efficacy in improving bone mineral density (BMD) and reducing fracture risk... Full

Adalvo Eyes Early Generic Semaglutide Access In Europe As Data Exclusivity Lifts

(9/19, Dean Rudge, Generics Bulletin) ...Adalvo has announced that it will file a decentralized procedure application in the EU for generic semaglutide in February 2026 – timed precisely with the expiry of data exclusivity for Novo Nordisk's Ozempic GLP-1 agonist blockbuster...On the legal side, Sandoz's Hexal, Viatris's Generics UK, Teva, and Galenicum have each actively opposed key EU semaglutide patents before the European Patent Office, securing already appeal-level wins against major oral-formulation claims and an obesity-use claim... Global Sub. Full

Lupin Gets US FDA Approval For Generic Lenalidomide Capsules

(9/18, Heena Ojha, NDTV Profit) ...Lupin Ltd. received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Lenalidomide Capsules within the range of 2.5 mg to 25 mg, the company said in an exchange filing...This product will be manufactured at Lupin's Pithampur facility in India. Lenalidomide Capsules, 2.5 mgh, 25 mg had an estimated annual sales of $7,511 million in the United States... Full

Biocon Arm's Retinal Disorder Medication Yesafili Gets Public Funding in Canada

(9/18, Megha Rani, CNBC TV-18) ...Biocon Ltd's subsidiary, Biocon Biologics Ltd (BBL), announced that Yesafili (aflibercept), its biosimilar to Eylea, is now publicly funded in Ontario, Canada, for the treatment of retinal diseases. The funding covers both vial and prefilled syringe presentations of 2 mg/0.05 ml dosage, making treatment more accessible to patients under the province's public insurance system... Full

Dutch Ustekinumab Ruling Diverts From UK As Samsung Bioepis Challenge Fails

(9/19, Dean Rudge, Generics Bulletin) ...Samsung Bioepis faces a setback in the Netherlands after the Hague District Court upheld Janssen's patent for Stelara (ustekinumab) in treating ulcerative colitis. This ruling prevents Samsung Bioepis from expanding the label of its biosimilar, Pyzchiva, to include this indication, and contrasts with the conclusions of a prior ruling from the UK High Court. The Dutch court found Janssen's patent to be novel, inventive, and adequately defined, and ordered Samsung Bioepis to pay €190,000 in legal costs... Global Sub. Full

Adaptability Key for Success in Uncertain Times: Sun Pharma's Shanghvi

(9/18, Press Trust of India) ...Dilip Shanghvi of Sun Pharma emphasized the importance of quick adaptation for business success. He spoke at an IFQM Symposium. Vivek Chaand Sehgal of Motherson Group sees challenges as growth opportunities. He noted unpreparedness leads to failure. Both leaders highlighted navigating the 'BANI' world. They believe adaptability is key for future success... Full

Fujifilm, Argenx Expand Partnership to Bring Vyvgart Production to the US

(9/18, Kevin Dunleavy, Fierce Pharma) ...In addition to manufacturing drug substance for argenx's autoimmune blockbuster Vyvgart at its facility in Hillerød, Denmark, Fujifilm will also make the product at its large-scale complex in Holly Springs, N.C. The CDMO will initiate production of Vyvgart at the plant in 2028...Deals are coming quickly for Fujifilm as the industry reacts to the threat of sector-specific tariffs on pharmaceutical imports under the second Trump administration. While many companies are making huge investments to build their own manufacturing sites in the U.S., some are turning to CDMOs that have plants in the U.S... Full

Roche Strikes $3.5 Billion Deal for U.S.-Israeli Biotech 89bio

(9/18, CTech) ...The Roche deal caps a rapid ascent from startup to acquisition target in less than a decade. The company was founded after licensing a pipeline of liver and metabolic drug candidates from Teva Pharmaceutical Industries, Israel's largest drugmaker. 89bio secured $60 million in Series A funding in 2018 from OrbiMed Advisors, Longitude Capital, RA Capital, and Pontifax. The founding team included veterans of Teva's R&D unit, among them Michal Ayalon and Ram Waisbourd. Michael Hayden, Teva's former global R&D chief, joined as a founding board member... Full

Chong Kun Dang, Novo Nordisk Partner On Obesity Drug

(9/18, Kim Eun-jin, Business Korea) ...Chong Kun Dang (CEO Kim Young-joo) announced on September 18, that it has signed a co-promotion agreement with Novo Nordisk Pharma Korea (CEO Casper Roseeuw Poulsen) for the obesity treatment Wegovy® (generic name: semaglutide) at its headquarters in Chungjeong-ro, Seoul. Through this agreement, both companies will jointly conduct sales and marketing activities for Wegovy® targeting domestic hospitals and clinics from October 1... Full

The Promise and Hurdles of the New Weight-Loss Pills

(9/18, Peter Loftus, The Wall Street Journal) ...Some people don't like needles and view pills as more convenient. And pills will be easier and less expensive for drugmakers to manufacture compared with more complex injectables. That might make them cheaper than the popular Wegovy and Zepbound shots...Novo Nordisk's pill version of semaglutide—the main ingredient of both Wegovy and diabetes treatment Ozempic—is positioned to become the first GLP-1 pill approved specifically for weight loss. The company has applied for U.S. Food and Drug Administration approval, and a decision is expected by the end of the year, setting up a potential launch by early 2026. Eli Lilly's offering has a new main ingredient, orforglipron, which works differently than the main component of its injectable Zepbound, tirzepatide...The company plans to apply for FDA approval by the end of the year, setting up a potential launch sometime during 2026... Sub. Req’d

'RSV Antibody Beyfortus Seen as Key to Stabilizing Healthcare System'

(9/19, Hong Sook, Korea Biomedical Review) ...However, while Beyfortus is similar to vaccines in terms of preventive efficacy, its approval in Korea as a "preventive antibody injection" rather than a vaccine has created obstacles to NIP inclusion. To address this, Korea Biomedical Review met with Cesar Mascareñas, Global Medical Head for the International Region at Sanofi, to discuss Beyfortus' preventive value and its public health benefits if adopted into the NIP... Full

Fire at Aurobindo Pharma's Andhra Unit Halts Production Temporarily

(9/19, Press Trust Of India) ..."The incident resulted in a temporary production impact estimated at about 3 per cent of the monthly capacity of the said unit. Necessary steps have been initiated for refurbishment and restoration, and we expect the impacted areas to be operational within the next few weeks," Aurobindo Pharma noted... Full

Sandoz Underlines Significance Of European Antibiotic ‘Sovereignty'

(9/19, Dave Wallace, Generics Bulletin) ...Sandoz has backed a European initiative aimed at bolstering local manufacturing capacity for antibiotics. A communiqué adopted at the European Forum Alpbach aims to safeguard and strengthen EU-based antibiotic production. It warns that "Europe's production capacity is under threat, with over 80% of global API supply currently sourced from China."... Global Sub. Full

The Italian and European Pharmaceutical Industry in the World: Discussion with Policy Makers at Connact Pharma

(9/18, Eunews) ...A window of optimism is opened by Marco Mattei, chief of staff to the Health Minister Orazio Schillaci: "Pharmaceuticals is a sector that must be structurally modified," he stresses, and therefore it is necessary to "make organic legislation" on the subject. The issue, once again, is "increasing the attractiveness" of the country system for foreign investors, starting with the "valorisation of research." For him, too, there is a need for greater integration in the European sphere, and Brussels should clearly decide on which subjects it should assume exclusive competence. After all, the guests note, pharmaceuticals is one of the driving sectors of our GDP... Full

Why Pharma Companies Are Suddenly Pausing Investment in the U.K.

(9/19, David Grainger, STAT+) ...With a most-favored nation pricing policy in the U.S., companies are not going to accept low prices that would destroy margins in their largest market. They will lose U.K. sales if they have to, and U.K. patients will lose access to the most innovative (and expensive) medicines. The only solution lies in collaboration. The U.K. government will need to show that it understands the predicament of the pharmaceutical companies, which then in return may recognize the economic and political shackles that constrain every Western government... Sub. Req’d

The High Stakes Fight Over Drug Prices

(9/19, Jessica Davis Plüss, Swissinfo.ch) ...Pharma companies argue that drug regulators aren't rewarding innovation fairly and are asking for unnecessary and costly evidence of the benefits of new treatments. Health authorities, however, worry about the rising cost of innovative medicines and about overpaying for drugs amid growing political and financial pressure to curb skyrocketing spending. "There is this political tension between how much money do we have and what do we want to pay for," said Karin Steinbach, a drug pricing expert at Lattice Point Consulting in Geneva. "Countries want patients to get the treatment they need but they also need to have cost control."... Full

How a Clash with Roche Exposed Cracks in Switzerland's Drug Pricing System

(9/19, Jessica Davis Plüss, Swissinfo.ch) ...The failed negotiations meant the FOPH removed Lunsumio from the reimbursement list of its compulsory health insurance system, known as the Specialities List, denying patients access to the treatment. Roche could have done what it's done before – allow it to be reimbursed in individual cases. Instead, it took the far more drastic step of a full market withdrawal. The company is still supplying Lunsumio free of charge to existing patients through a Patient Access Programme, backed by a non-profit medical association, which ensures continuity of care for those already undergoing treatment. But the drug won't be available to any new patients unless they import it and pay for it themselves... Full

Dutch Export Figures Reveal US Drug Stockpiling

(9/18, Christoph Schwaiger, Euractiv) ...More drugs were exported from the Netherlands to the US in the first half of 2025 compared to the same period last year, according to new figures from the Dutch statistics office..."The export numbers showed stockpiling of goods as was to be expected," ING Healthcare Economist Diederik Stadig told Euractiv. "In general, we are seeing a gradual repositioning of capital and existing capacity from pharma companies to the US and away from Europe and other geographies, which may prove a risk to UK and European economies."... Full

China's API Price Cuts Undermine India's Self-Sufficiency Push

(9/18, The Pharma Letter) ...In a move reminiscent of past trade disputes, China appears to have launched a price war on key active pharmaceutical ingredients (APIs), directly challenging India's push for self-reliance in the pharmaceutical sector. The ploy, which has seen prices for critical drug components slashed by as much as 50%, is being widely condemned by Indian manufacturers who allege that it is aimed at crippling nascent Indian API plants established under a government-backed initiative, reports The Pharma Letter's India correspondent... Sub. Req’d

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