Wednesday, October 22, 2025

Formycon And Teva Eye Ranibizumab Advantage With European PFS Launch

(10/21, Dave Wallace, Generics Bulletin) ...Formycon and Teva have set out plans to gain an advantage in the European market for biosimilar ranibizumab by launching a unique first pre-filled syringe formulation of their partnered FYB201 Ranivisio rival to Lucentis...Michal Nitka – Teva's senior vice president, head of generics in Europe, and global head of OTC – said the firm was "pleased to offer healthcare professionals and patients a treatment solution, further expanding access to high-quality medicines."..."At Teva, we are committed to pushing boundaries to deliver the right medicines whenever they are needed," Nitka stated... Global Sub. Full

US Pharma Price Probe Raises Threat of New Drug Tariffs

(10/22, Aime Williams and George Parker, Financial Times) ...Donald Trump's administration is stepping up attacks on US trading partners over drug pricing, preparing a new probe that would lay the ground for a fresh barrage of tariffs. The imminent investigation, which would come under Section 301 of the Trade Act of 1974, would consider whether any US trading partners are underpaying for drugs, said three people familiar with the matter...The new US investigation could lead to tariffs on any products or goods the White House chooses and will reignite global trade tensions that had calmed for most trading partners after Trump walked back some threatened duties and struck deals with countries... Sub. Req’d

Companies Tout a Novel Payment Model for Obesity Drugs, Other Medications in Drive to Lower Costs

(10/22, Elaine Chen, STAT+) ...One company, RxSaveCard, is charging employers a set fee to help them set up this model. CEO Chris Crawford said in an interview that the company has seen interest take off as more pharma companies launch direct-to-consumer sales and that hundreds of employers have either already signed up for RxSaveCard or will be adopting the model next year. Another new company, Andel, announced this week that it will launch a platform that will adopt a similar model for GLP-1 treatments and eventually for other branded drugs as well...Proponents of direct-to-consumer drug sales say that they're lowering costs for patients in part by bypassing pharmacy benefit managers, entities that they blame for inflating costs. But drug pricing experts said that the models proposed by RxSaveCard and Andel look very similar to the PBM model — negotiate drug prices with pharma companies and help employers decide how much cost they take on... Sub. Req’d

Initial Medicare Price Offer For Ozempic, Wegovy Almost Half Off Net, Analysis Suggests

(10/21, Cathy Kelly, Pink Sheet) ...The Medicare price negotiation program may cut the estimated net prices for Novo Nordisk's Ozempic and Wegovy by nearly half in Medicare Part D, based on a recent analysis. The study by University of Washington and University of California, San Diego researchers projected initial price offers for the 15 drugs currently subject to negotiation using agency guidance and experience with the initial negotiation cycle. The Trump Administration is interested in lowering costs of GLP-1 drugs for obesity in Medicare and Medicaid...Projections suggest Salix's Xifaxan and Novo Nordisk's semaglutide drugs may get the deepest reduction off the net price, while Teva's Austedo may face the smallest reduction. Prices reflects 30-day supplies... Global Sub. Full

What Might Happen If MA Shifted Certain Drugs From Part B To Part D?

(10/21, R. Brett McQueen, Health Affairs) ...This shift could improve care coordination and create opportunities for cost savings through enhanced formulary flexibility in MA plans. However, it's important to consider potential issues regarding access and affordability, particularly for beneficiaries who need expensive specialty drugs. Ultimately, further exploration of this transition in MA could reveal benefits for both patients and payers, but careful policy design is essential to ensure a balance between cost management and equitable access to medications... Full

‘We Need to Pick a Lane': Lilly Oncology President Weighs in on FDA Cancer Drug Policies

(10/21, Angus Liu, Fierce Biotech) ...While most of what the FDA laid out in a recent draft guidance on the assessment of overall survival in oncology clinical trials was expected, the document still raised one concern for Eli Lilly's oncology chief, Jake Van Naarden, and other experts. In the draft guidance, released in August, the FDA suggested that "in general," the use of crossovers in oncology clinical trials "should be limited."...Simultaneously, the FDA is pushing for more U.S. patient representation in oncology trials...To Van Naarden, these two policies are not compatible with each other... Full

FDA Officials: High-Quality Data is Essential for AI Tools for Generic Drugs

(10/21, Joanne S. Eglovitch, Regulatory Focus) ...Robert Lionberger, director of the US Food and Drug Administration's (FDA) Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD), emphasized the critical need for high-quality data to support artificial intelligence and machine learning (AI/ML) models during a workshop held on October 15... Full

Samsung Bioepis, Celltrion Pivot to ADCs and Bispecific Antibodies

(10/21, Yeom Hyun-a, ChosunBiz) ...Samsung Bioepis and Celltrion, the leading corporations in domestic biosimilars (copycat versions of biologic drugs), have moved in earnest into new drug development. Their strategy is to expand research and development into new drugs based on clinical trial and regulatory approval experience accumulated through the biosimilar business. Attention is on whether the moves by the two companies will become a breakthrough as development of homegrown new drugs remains slow... Full

Regeneron's Patent Settlement with Celltrion Paves Way for Another Eylea Biosimilar in 2026

(10/21, Alexis Kramer, Endpoints News) ...Regeneron announced that it has resolved patent infringement claims against the South Korea-based biosimilar maker, and all intellectual property-related litigation will be dismissed. Celltrion will be able to launch its product on Dec. 31, 2026, Regeneron said Monday... Sub. Req’d

Celltrion Settlement Provides US Date For Aflibercept Entry

(10/21, Dave Wallace, Generics Bulletin) ...In a brief update, the originator announced that it had "reached resolution of our patent infringement litigation related to the Celltrion Eylea (aflibercept) injection 2mg biosimilar product."...As the aflibercept settlement was announced, Celltrion also published preliminary results for the third quarter of 2025. The Korean firm said its Q3 revenue "exceeded KRW1trn ($699m), up 16.3% to KRW1.026trn." Biologics sales – the bulk of the firm's turnover – were up by 18.3% to KRW958.3trn, with Celltrion noting that "high-margin young products recorded a 50.5% year-on-year increase, with key products such as Remsima SC (infliximab), Zymfentra (infliximab) and Steqeyma (ustekinumab) driving overall revenue growth."... Global Sub. Full

Alembic Pharma Gets USFDA Okay for Triamcinolone Acetonide Injectable Suspension

(10/22, Ruchika Sharma, Medical Dialogues) ...Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application (ANDA) Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL Single-Dose Vials, 200 mg/5 mL and 400 mg/10 mL (40 mg/mL) Multiple-Dose Vials... Full

Endo Lands First US Ravicti Generic To Boost Rare Diseases Portfolio

(10/22, Dean Rudge, Generics Bulletin) ...Endo has launched the first US generic version of Amgen's Ravicti, indicated for patients with urea cycle disorders, following a patent litigation settlement signed in 2018. The original patent for Ravicti expired in July 2018, with additional patents valid until 2030 and 2032. Following its recent merger with Mallinckrodt, Endo will see its generics business spun off in the near future as part of the combined firm's Par Health segment... Global Sub. Full

Supreme Court Boosts Natco In Ongoing Patent Row With Roche Over Risdiplam

(10/21, Dean Rudge, Generics Bulletin) ...The Supreme Court of India has ruled in favor of Natco Pharma, allowing it to continue selling its generic version of Roche's spinal muscular atrophy drug, Evrysdi (risdiplam). This decision follows the Delhi High Court's earlier ruling that denied Roche an injunction against Natco, as the patent infringement dispute continues in lower courts. Natco promptly launched its generic product at a substantially lower price compared to Roche's original drug... Global Sub. Full

FDA Accepts NDA for Nilotinib Biosimilar XS003 for Chronic Myeloid Leukemia

(10/21, Jax DiEugenio, OncLive) ...The FDA has accepted a new drug application seeking the approval of XS003, biosimilar referencing nilotinib (Tasigna), for the treatment of patients with chronic myeloid leukemia (CML)...Developed using Xspray Pharma's proprietary HyNap technology, XS003 demonstrated bioequivalence to the reference product at less than half the dose, according to data from registration studies. The formulation also showed a significantly reduced food effect—29% compared with 82% for nilotinib—suggesting that XS003 may be taken with or without food, pending FDA review of final labeling and related warnings... Full

How J&J Kept Growing Amid the Erosion of Cornerstone Drug Stelara

(10/22, Nick Paul Taylor, BioSpace) ...The growth reflects J&J's multi-year effort to adapt its business for a post-Stelara future. Some parts of the business have been sacrificed to enable investment in the most promising programs...As J&J pulled back from infectious diseases and vaccines, it invested in other areas to ensure new growth drivers were in place to ease the Stelara transition. At J&J's immunology unit, rising sales of Tremfya and Simponi are partly offsetting the decline of Stelara and the development of icotrokinra, JNJ-4804 and nipocalimab are laying the groundwork for a potential new-look portfolio... Full

Novo's Board Bust-Up to Sharpen Drugmaker's Focus on US Consumers

(10/22, Bhanvi Satija and Maggie Fick, Reuters) ...On Tuesday, Novo's top investor, the non-profit Novo Nordisk Foundation, moved to take control of the company's board. It vowed a sharper focus on the key U.S. market to boost sales growth for Wegovy, and flagged a need to move faster on burgeoning mass-market channels. The incoming chair, former CEO Lars Rebien Sorensen, said the drugmaker faced a dynamic and more consumer-focused obesity market in the United States, a market that he called "our daily bread". He criticised the board for being too slow to recognise the shift... Full

Alvotech Announces Changes in Global Business Development and Commercial Operations Team

(10/22, Alvotech) ...Alvotech...today announced changes to its global business development and commercial operations team. Anil Okay, Chief Commercial Officer, is stepping down to serve as Chief Executive Officer of Adalvo. Trisha Durant has joined Alvotech as Senior Vice President, Global Business Development and Commercial Operation, ex-North America. Harshika Sarbajna is Senior Vice President Commercial, North America. Agne Pasko is Vice President Head of Business Development... Full

Purdue Pharma Gets Over 99% Voting Support for Bankruptcy Plan

(10/21, Dietrich Knauth, Reuters) ...More than 99% of bankrupt drugmaker Purdue Pharma's creditors voted to accept a $7.4 billion settlement of legal claims related to the company's sales of addictive opioid medication, the company said Tuesday... Full

Antidepressant Side Effects Vary Widely by Drug, Study Finds

(10/21, Chloe W. Shakin, The New York Times) ...A new large-scale analysis found that the short-term cardiovascular and metabolic side effects of antidepressants vary widely by drug, but the ones most commonly prescribed in the United States are linked to relatively mild issues...A wide variety of drugs were reviewed, including selective serotonin reuptake inhibitors (S.S.R.I.s) like sertraline (Zoloft) and fluoxetine (Prozac); serotonin-norepinephrine reuptake inhibitors (S.N.R.I.s) like duloxetine (Cymbalta) and venlafaxine (Effexor); and norepinephrine-dopamine reuptake inhibitors (N.D.R.I.s) like bupropion (Wellbutrin)... Sub. Req’d

Richard Sullivan: The NHS Drug Pricing Crisis – Pharma Withdrawals, Rising Costs, and China's Expanding Influence

(10/21, OncoDaily) ...The government's knee-jerk reaction has been to float the idea that they will pay up to 25% more for drugs to keep the industry on board. But look behind the curtain and a far more tangled web emerges. Western biopharma is under enormous pressure from China as the latter expands not just its pharmaceutical base but also its global health footprint. Cancer medicines feature heavily in this equation. At its current trajectory, China is likely to be a major global supplier in the next decade... Full

GT Voice: Europe's Reliance on Asian APIs Reflects Complementarity, Not Risks

(10/21, Global Times) ...A recent study by the German Economic Institute has again thrust Europe's reliance on imports for its medicines into the spotlight. Research showed that 68 percent of the active pharmaceutical ingredients (APIs) in the European market come from Asia, with China accounting for 24 percent and India 37 percent, according to the institute's latest study released on Monday. The data has sparked discussion and concern among some in Europe about supply chain risks, which some media outlets have described as "very high."... Full

German Pricing System Is Tougher On Drugs Targeting Smaller Patient Populations

(10/21,Francesca Bruce, Pink Sheet) ...Germany's AMNOG benefit assessments, which influence the pricing of new products, appear to be more challenging for medicines targeted at small patient populations, indicates analysis from the pharmaceutical industry group, the VFA. The proportion of benefit assessments leading to positive ratings appears to be falling. Companies and health insurers are able to successfully negotiate prices for the vast majority of drugs that pass through the AMNOG system, the analysis shows... Global Sub. Full

Canadian Public Drug Plan Spending Grew by $3.4 Billion Over 5 Years, Driven by Use of Higher-Cost Drugs

(10/21, Patented Medicine Prices Review Board) ...The latest edition of the Patented Medicine Prices Review Board (PMPRB) CompassRx report shows that prescription drug expenditure for public drug plans grew by 7.4% in 2022/23 to reach $14.1 billion, compared to $13.2 billion in 2021/22. Drugs costing over $10,000 annually accounted for over one third of total drug costs for the public drug plans and were only used by 3% of beneficiaries. The 10 highest-cost drugs were rare disease treatments that each had annual treatment costs exceeding $300,000... Full

Bitter Pill: Exposure of Indian Pharma to US Tariffs

(10/21, Shekhar Tomar and Sahiti Priyamvada Vallabhaneni, The Hindu BusinessLine) ...If US tariffs hit the generics segments, it would engender an erosion of scale economies given large exposure to the US market. This will significantly hurt pharma growth as it would attenuate incentives for investment in regulatory compliance and pharmacological innovation, thereby having an impact on the sector's dynamism. The problem is however worse for the firms that export to the US as they are less diversified than the overall market. Since pharma is a highly regulated industry in most countries, variation in regulation and logistical barriers would prevent smooth reorganisation of supply chains to other markets... Sub. Req’d

Russian Government to Double the Volume of Localized APIs Within Next Five Years

(10/22, The Pharma Letter) ...This has been recently announced by Anton Alikhanov, Russia's Minister of Industry and Trade, who is a state official personally responsible for the development of pharmaceutical sector in the Russian government. He said during the recent Bioprom forum that, as one of Russia's most important events in the field of pharmaceutics, as of now, Russia has almost completely localized the production of drugs from the list of vital and essential, while the same plans are in case of active ingredients. According to the Minister, the volume of their production in Russia will be doubled within the next 5 years... Sub. Req’d

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