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The industry is bracing for the impact of Korea’s drug pricing reform, which reduces prices for generics and post-patent drugs while rewarding innovationCompanies reliant on generics face steep profit drops, while innovative firms may see relative gains. Profit margins for small and medium-sized firms are at higher risk due to fixed costs and R&D demandsCompanies can offset the reform's impact by exploring overseas markets, licensing technologies, securing CDMO partnerships, launching non-reimbursable products, and leveraging the flexible pricing system, but these strategies involve certain risks
Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) has implemented a package of new rules governing pharmaceutical reimbursement applications, pricing and generic substitutionFrom October 1, three new sets of regulations apply alongside new general reimbursement and pricing guidelines: HSLF-FS 2026:23 on applications for subsidy and pricing, HSLF-FS 2026:14 on the pricing of interchangeable medicines, and HSLF-FS 2026:16 on medicine substitution“The changes are intended to improve access to effective medicines and to ensure that society’s costs for medicines remain reasonable and sustainable over time,” the Agency stated
The Council of the European Union adopted the EU pharmaceutical reform package by a 26-0-1 voteThe legislation aims to balance incentives for pharmaceutical innovation with measures to improve patient access, strengthen medicine supply security, and create a more predictable regulatory environment for manufacturersNow that the Council has voted, the European Parliament must formally adopt both the regulation and the directive comprising the package. The Parliament’s vote is expected October 2, 2026
Last week, NAVLIN Daily brought you key market access developments from across the globe In the U.S., new details emerged on MFN drug pricing deals with Pfizer and Eli Lilly, while all 50 states, the District of Columbia, and Puerto Rico applied to join the GENEROUS drug pricing modelIn Japan, the medical insurance system has incorporated Amchepry, the first commercialized iPSC-based treatment for Parkinson’s in the world, while China released its 15th Five-Year Plan for its pharmaceutical industry, which sets ambitious goals, including 20% annual growth for innovative drugs and at least five global blockbusters surpassing $1 billion in sales
Germany’s Federal Joint Committee (G-BA) has raised significant concerns over proposals from the Federal Ministry of Health (BMG) to reform the AMNOG benefit assessment process, warning that the planned special pathway could apply to more than 60% of assessments for medicines with new active substancesG-BA Chair Dr. Sonja Optendrenk said mandatory reassessments after three to four years could substantially increase the number of AMNOG procedures and administrative work for both pharmaceutical companies and G-BA, while potentially increasing statutory health insurance (GKV) pharmaceutical expenditureOptendrenk proposed maintaining the existing data-based benefit assessment for all medicines with new active substances, while allowing G-BA to carry out an additional qualitative assessment in specific treatment situations with increased medical need and, where appropriate, determine that a medicine has potential for a therapeutically relevant additional benefit
Novartis and Eli Lilly face a petition in India's Kerala High Court asking for lower prices on breast cancer drugs ribociclib and abemaciclibNovartis made $12.7B globally from ribociclib between 2020-25, with just $55.7M from India. Lilly earned $19.6B from abemaciclib globally in the same span, compared to $31.5M in India. Both companies argue high development costs but didn’t share exact numbers with the courtThe petition has also brought the manufacturing cost of ribociclib into focus. Producing a 200 mg ribociclib tablet reportedly costs about ₹81 ($0.84) when the active pharmaceutical ingredient (API) is manufactured in-house and roughly ₹123 ($1.28) when the API is imported
The European Union’s joint clinical assessment (JCA) of Innovent Biologics’ Tyvyt (sintilimab), co-developed with Eli Lilly, has been discontinued after the company’s updated dossier was found to contain substantial gaps in study information, evidence retrieval, and the methods underpinning its indirect treatment comparisons“In the dossier, insufficient information and data are provided on the characterization of the included studies and interventions, the course of included studies, and other characteristics. In addition, detailed information on outcomes (e.g., definition of outcomes, planned and actual follow-up times, imaging intervals) is missing,” the European Commission noted. “This information, in principle, is mostly contained in the Clinical Study Report (CSR) of the study ORIENT-11 and in publications of the studies on comparators”Sintilimab is the fourth JCA to be discontinued, with Sasanlimab, following withdrawal of its EMA marketing authorization application, and catequentinib and Tacquell, which were both discontinued after their JCA dossiers failed to satisfy the requirements under Article 9(2), (3) and (4)
The EU’s overhaul of pharmaceutical legislation has entered the final stages of the legislative process, with the Council setting out detailed first-reading texts covering regulatory protection, medicine launches, orphan-drug incentives, antimicrobial resistance, shortages, environmental requirements, and a major restructuring of the European Medicines Agency (EMA). The Council’s formal adoption of its position at first reading and statement of reasons is scheduled for September 28Council documents 7105/26 and 7106/26 set out, respectively, the new Regulation governing centralized medicines procedures and the EMA, and a new Directive establishing the Union code for medicines for human useThe final framework keeps eight years of regulatory data protection, followed by one year of market protection, with extra protection available in certain circumstances. Meanwhile, under Article 59, a Member State can request that a marketing authorization holder place a protected medicine on its market and supply enough product to meet patient needs
Newly released but heavily redacted copies of the U.S. administration’s Most Favored Nation (MFN) agreements with Eli Lilly and Pfizer have been obtained and published by Public Citizen, offering glimpses of information related to previously undisclosed pricing, reporting, and implementation provisionsLilly’s agreement appears to exempt GLP-1 products such as Mounjaro and Zepbound (tirzepatide) from the GENEROUS model, and allows for the omission of patient assistance programs, free drug programs, and similar offerings from manufacturer-reported net pricesMeanwhile, Pfizer’s agreement appears to confirm that GENEROUS prices are excluded from Medicaid Best Price and do not impact 340B ceiling prices. The text also indicates that the company will share with the U.S. government a portion of revenue associated with increases in net prices for ex-U.S. products covered by the agreement
Last week, NAVLIN Daily brought you key market access developments from across the globe In Europe, a Lancet study found that drugmakers may raise prices or delay launches abroad to offset losses from the U.S. MFN policy, while Germany explored a potential pharmaceutical pricing deal with Washington to avert the threat of additional tariffs Spain also pushed for greater EU coordination on access to innovative medicines while China wrapped up negotiations for its NRDL, with 124 drugs currently absent from the catalog potentially gaining access
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