Wednesday, June 11, 2025

Trump Team Expected To Unveil Next Steps On MFN Drug Pricing Soon

(6/10, Maaisha Osman, Inside Health Policy) ...The Trump administration is expected to release more details in the coming days on its plan to lower drug prices by using the most favored policy through a potential Center for Medicare & Medicaid Innovation (CMMI) model, three people familiar with the matter told Inside Health Policy. HHS already made price offers to pharmaceutical companies based on the MFN policy, according to the White House... Sub. Req’d

As Drug Price Target Deadline Looms, Pharma Companies Weigh Options

(6/10, Daniel Payne, STAT+) ...A Washington representative for one pharmaceutical company, granted anonymity to discuss internal thinking, said the company expects more details this week, likely on Wednesday. The company has been mapping out the possible impacts of different policies, considering a wide range of possible price targets from the administration. Those could include a reduction in price by a certain dollar amount, a percentage reduction of current U.S. prices, setting U.S. prices at a percentage of prices from other countries, or something different altogether... Sub. Req’d

Drug Pricing Reform Talks with US Government Lack Clarity, Industry Executives Say

(6/10, Bhanvi Satija, Christy Santhosh, Reuters) ...Talks with the Trump administration about lowering U.S. drug prices have so far not provided clarity on when and how reduced prices will be implemented, top executives from Eli Lilly and Merck said at an industry conference on Tuesday...Lilly and Merck executives said that any pricing reforms would require regulatory changes or government-to-government actions. AbbVie's CEO also said that there was a "long way to go" before an agreement would be reached on the pricing reform... Full

Trump Shouldn't Import Socialist Price Controls

(6/10, Merrill Matthews, The Hill) ...That "most-favored" country will almost certainly be one with government-run health care — that is, socialized medicine. These systems are known for price controls, which lead to shortages, long wait times, and limited access to cutting-edge treatments...If Trump wants to stop other countries from taking advantage of us, he should take the approach he's using to get countries to pay more for defense. Cuban's Cost Plus experiment proves we don't need Most Favored Nation pricing. Let socialized systems keep their socialized prices, limited access and denial of care... Full

Most Voters in Favor of Trump's ‘Most Favored Nation' Drug Price Policy: Survey

(6/11, Joseph Choi, The Hill) ...In a survey commissioned by the Pharmaceutical Reform Alliance and conducted by National Research Inc., 85 percent of voters said prescription medications have gotten more expensive and nearly the same percentage of participants said pharmaceutical companies carried the most blame for the high cost. When asked about their voting choices, 86 percent said they were more likely to support a candidate who "wants to force Big Pharma to lower prescription medication costs for American consumers" while 78 percent said they were less likely to support a candidate who accepted donations from Big Pharma... Full

Trump Tariffs Can Stay in Effect Longer, Appeals Court Says

(6/10, Zoe Tillman and Erik Larson, Bloomberg Law) ...Donald Trump can continue to enforce his global tariffs for now, a federal appeals court held in a win for the president on one of his signature economic policies. The order Tuesday by the US Court of Appeals for the Federal Circuit extends an earlier, short-term reprieve for the administration as it presses a challenge to a lower court ruling last month that blocked the tariffs. The Justice Department had argued that US officials' concerns about ongoing trade negotiations outweighed the economic harm claimed by the small businesses that sued... Sub. Req’d

Makary, Prasad Plan New Pilot Program For Swifter Drug Approvals

(6/10, Luke Zarzecki, Inside Health Policy) ...FDA Commissioner Marty Makary and biologics center director Vinay Prasad laid out their priorities for the agency in a Journal of the American Medical Association article Tuesday (June 10), saying they will establish a new pilot program to speed up drug approvals, aim to lower drug costs and use artificial intelligence for drug investigations and postmarket surveillance. The FDA leaders emphasized accelerating cures, unleashing AI, researching food ingredients, leveraging data and addressing drug costs as their top priorities... Sub. Req’d

Requiring Humira Biosimilars Results in Huge Savings for Navitus Clients

(6/10, Denise Myshko, Managed Healthcare Executive) ...Commercial clients of Navitus Health Solutions saw a 60% reduction in net cost per claim after the PBM removed the arthritis drug Humira (adalimumab) from its formularies in favor of three biosimilar options...Navitus' specialty pharmacy will offer an unbranded biosimilar that the PBM estimates will save between $112,000 and $336,000 per patient per year compared with the annual per-patient cost of the reference product. Lumicera Health Services has made a purchase agreement with Anda, a subsidiary of Teva Pharmaceutical, for a lower-priced biosimilar version of Stelara. The Stelara biosimilars are expected to deliver net savings of 85% per claim and significantly drop prices for ustekinumab in 2025 and 2026, the Navitus report predicts... Full

Specialty Drug Utilization Grows

(6/10, Paige Twenter, Becker's Hospital Review) ...In 2024, the cost and utilization of specialty dermatology drugs significantly drove a 7% increase in pharmaceutical costs, according to a June 10 report from Navitus Health Solutions, a pharmacy benefits manager. Although specialty medications accounted for less than 2% of utilization, they drove 52% of net pharmaceutical spend in 2024, the report found... Full

Celltrion and Onconic Team Up On Ovarian Cancer Combo with Dual-Target PARP Drug

(6/11, Kim Ji-hye, Korea Biomedical Review) ...Korean biotech Onconic Therapeutics is teaming up with biosimilar giant Celltrion to develop a new treatment option for relapsed ovarian cancer, combining Onconic's dual-mechanism small molecule nesuparib with Vegzelma, Celltrion's bevacizumab biosimilar already approved in major markets for colorectal and breast cancers... Full

OneSource Specialty Pharma Partners with Swedish Biotech Company Xbrane, On its Biosimilar Portfolio

(6/11, The Hindu BusinessLine) ...As part of the agreement, Xbrane will undertake a tech-transfer of its commercial product to OneSource's integrated drug substance and drug product (DS/DP) facility in Bengaluru. The collaboration aims to strengthen Xbrane's global supply chain, while enabling OneSource to accelerate regulatory approvals, including from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), for its biologics drugs substance facility, the note said... Full

Lilly Pacts Prohibit Telehealth Sales of Copycat Zepbound

(6/10, Madison Muller, Bloomberg Law) ...Eli Lilly & Co. will only work with telehealth firms that agree to stop selling copycat versions of weight-loss drugs, diminishing the likelihood of a partnership with one most visible players in the industry, Hims & Hers Health Inc...The new agreements will enforce "that as long as the product is out of the shortage list, that those telehealth services are not compounding either tirzepatide or semaglutide," [Lucas Montarce, Lilly's chief financial officer] said, referring to the active ingredients in Zepbound and Wegovy. "It's also another way to move those into the original brands."... Sub. Req’d

‘Brainless' US MFN Policy Could Drive Pharma Investment To Europe

(6/10, Francesca Bruce, Pink Sheet) ...Anja Schiel from Norwegian health technology assessment body NOMA tells the Pink Sheet why she thinks plans to introduce a most favored nations drug pricing policy in the US are badly thought out and why they will not work. Drug prices in Europe are already too high and payers in the region will not accommodate higher prices. Instability in the US could drive pharma companies to moves investment to Europe... Global Sub. Full

EU Pharma Deal Sparks Mixed Reactions in Sweden and Denmark

(6/10, Monica Kleja, Euractiv) ...Following the Council's pharmaceutical package agreement last Wednesday, the Swedish and Danish governments welcomed the proposal for retaining the current eight-year data protection period for new medicines. Critics are also pointing to the agreement's weakening of measures to fight the rising threat of antimicrobial resistance... Full

Bulgaria Backs Pharma Package in Principle, Wants Reimbursement Backstop in Trilogue

(6/10, Krassen Nikolov, Euractiv) ...The Bulgarian pharmaceutical industry has opposed the proposal to reduce the regulatory data protection (RDP) period for original medicines below the current eight years. Industry representatives have also expressed concerns about provisions extending the so-called Bolar exemption, which allows generic drug manufacturers to conduct studies and trials on patented medicines before the patent expires, solely for the purpose of obtaining regulatory authorisation... Full

EMA: Record Number of Drugs Recommended in 2024

(6/10, Ferdous Al-Faruque, Regulatory Focus) ...According to a new report from the European Medicines Agency (EMA), 2024 was a record year for recommending new drugs for authorization in the EU. The report also highlights how the agency has adapted to new technologies while navigating a changing and challenging regulatory landscape... Full

India's Pharmaceutical Exports to Africa Plateau at Record High

(6/11, The Guardian) ...Rollins John, the director for the Pharmaceuticals Export Promotion Council of India (Pharmexcil) based here made this observation on Monday when briefing visiting journalists from various countries in East and Southern Africa. The sustained upward trajectory underscores the continent's strategic importance as a key export market for India's pharma industry, with authorities in the South Asia economic giant reaffirming the wish to heighten relations and collaborations to expand pharmaceutical outreach... Full

Crisis Or Opportunity? US MFN Policy Could Test Japan's Appetite For Reforms

(6/11, Lisa Takagi, Pink Sheet) ...The ongoing uncertainties around US biopharmaceutical-related policies under President Donald Trump, including possible pharma trade tariffs and most favored nation (MFN) pricing, may present new opportunities for positive reforms in the Japanese market, say a number of expert observers in the country. While they have mixed opinions on the US policies, the final form of which still remains unclear, the commentaries share a common view of MFN in particular: it could change the value proposition of the Japanese market on a global scale, while also testing sustainability and innovation in Japan's own public healthcare system, along with its ability to reform... Global Sub. Full

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