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Last week, NAVLIN Daily covered key developments across the globe, including additions to TrumpRx, progressing EU legislation, and new pathways introduced for medicines in the UKMeanwhile, the South Korean industry continued to push back on planned reforms, and Spanish health ministers defended the country’s ongoing HTA decree MFN continued to make headlines as the Trump administration reportedly pushed Congress to codify the policy, while pharma companies began to rethink international out-licensing to avoid international pricing spillover risks
India's pharma market heats up as the patent for semaglutide expires in March 2026. Over 10 local firms, including Dr. Reddy’s, Sun Pharma, Glenmark, Natco Pharma, and Zydus, have launched cheaper generics, slashing treatment costs and expanding access to diabetes and obesity therapiesPrice wars are intense. Natco leads with Semanat and Semafull at $15.5/month, while Glenmark follows with Glipiq at $16–$21 per month. Alkem offers reusable and disposable options for nearly $21.6 per month, while Zydus offers reusable pen models Semaglyn, Mashema, and Alterme for $26.5 per monthMore premium products come from Sun Pharma 36–$96 per month, Dr. Reddy’s, $50.6m per month, and Torrent Pharma, $48.2 per month
A recurring theme at this year’s World Evidence, Pricing and Access (EPA) congress was the growing discomfort, from both industry and policy stakeholders, with how narrowly medicines are assessed within healthcare systemsJose Diaz, Global Health Systems Economics & Value of Innovation Lead at BMS, highlighted how medicines are often framed primarily as a cost to be contained, rather than an input that shapes outcomes across the wider systemDiaz stated that to advance the current debate on healthcare financial sustainability, it is “imperative to consider both key major drivers of health care expenditure and trends in pharmaceutical expenditure”
New analyses from both the New York Times (NYT) and Reuters found that discounted prices offered on TrumpRx are often still more expensive than negotiated prices in other countries, despite claims that the new website offers the lowest drug prices in the worldThe NYT found that out of 24 directly comparable medicines, greater than half were cheaper in Germany than on the TrumpRx website. Reuters, meanwhile, determined that prices offered for close to a third of the 54 drugs currently available on TrumpRx were lower in the UKThese reports represent the latest criticism of TrumpRx, which has been the object of intense scrutiny as stakeholders try to determine the true impact of the new service
The European Parliament’s Public Health Committee (SANT) has approved key trilogue agreements on the overhaul of the EU’s pharmaceutical legislationIn a vote held earlier today, Committee members backed both the proposed Regulation (29 votes in favour, 3 against, 6 abstentions) and Directive (30 in favour, 2 against, 6 abstentions), paving the way for the next stage of the legislative processThe next step will see the EU Council formally adopt its position at a first reading, expected by the end of September. Final approval by the European Parliament is expected by October 2, bringing the legislation closer to implementation across member states
At the National Institute for Health and Care Excellence (NICE) Conference in Manchester, NICE and the Medicines and Healthcare products Regulatory Agency (MHRA) discussed the two initiatives intended to accelerate patient access to innovative medicines.With the Aligned Pathway, NICE and MHRA reviews will be aligned to enable faster decisions with patient access 3 to 6 months earlier, supported by an improved Integrated Scientific Advice service to streamline evidence requirements and developmentIn October 2025, companies were invited to register as early adopters. To date, 27 companies have enrolled, with the first treatments now under review and initial NICE guidance anticipated by June 2026
A new batch of prescription medications has been added to TrumpRx, featuring products from Novartis, GSK, and AmgenProducts include: Anoro Ellipta (umeclidinium and vilanterol), Arnuity Ellipta (fluticasone furoate), Incruse Ellipta (umeclidinium), Relena (zanamivir), Aimovig (erenumab-aooe), Amjevita (adalimumab-atto), Repatha (evolocumab), Mayzent (siponimod), Rydapt (midostaurin), and Tabrecta (capmatinib) Following these additions, there are now eight companies with products featured on TrumpRx and a total of 54 prescription drugs listed on the website as of time of reporting
Last week saw key developments across Japan, the U.S., the EU and more, spanning drug pricing negotiations, MFN scrutiny, direct-to-patient models, and progress on the EU’s legislation review More ex-U.S. MFN effects came to light; In Japan, Astellas secured a lower price for Izervay (avacincaptad pegol) after 'leveraging’ the U.S. policy, although CEO Naoki Okamura did say it is unclear if authorities considered it. Meanwhile, democrats in the U.S. Senate sought more details on the 16 signed voluntary MFN deals In Europe, COREPER I endorsed the final compromise text on a key part of the EU’s pharmaceutical reform. The revised Directive introduces a launch obligation requiring drugmakers to make approved medicines available in requesting Member States within three years
At EPA Congress 2026 in Amsterdam, Anna Smith, NAVLIN Daily's Head of News, spoke with Neil Grubert, independent market access consultant, after his presentation on the key policy changes shaping the global access environmentIn the discussion, Grubert reflected on the interaction between U.S. Most Favored Nation (MFN) policy and changing policies in Europe and beyond, as well as why China deserves more attention Stay tuned as we publish interviews with other speakers and experts we interviewed at EPA
Japan’s Central Social Insurance Medical Council (Chuikyo) has approved the listing of 14 new medicines on the National Health Insurance (NHI) reimbursement price listThe batch includes several high-profile oncology and rare disease therapies, notably Janssen’s Rybrofaz (amivantamab/ vorhyaluronidase alfa), Chugai’s subcutaneous Lunsumio (mosunetuzumab), GSK’s Blenrep (belantamab mafodotin), Servier’s Voranigo (vorasidenib), and PTC Therapeutics’ Sephience (sepiapterin), all of which are expected to achieve peak annual sales exceeding ¥10 billionInterestingly, there are a few medicines that gained regulatory approval in Japan but will not be included in the next NHI listing: GSK's Exdensur (depemokimab), Eli Lilly's Inluriyo (imlunestrant), and Recordati's Inrebic (fedratinib)
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