Monday, October 6, 2025

Another Drug Pricing Demo Surfaces After Trump-Pfizer Deal

(10/3, Maaisha Osman, Inside Health Policy) ...Just days before the Trump administration announced a drug pricing agreement with Pfizer, HHS and CMS submitted a proposal for a new drug pricing demonstration -- the Global Benchmark for Efficient Drug Pricing (GLOBE) Model -- to the White House Office of Management and Budget (OMB) for review. That model is viewed as part of the president's most favored nation agenda to tie U.S. drug prices to lower prices in other industrialized nations... Sub. Req’d

Trump-Pfizer Deal Sparks Diametric Backlash From WSJ Board, MAHA Supporters

(10/3, Maaisha Osman, Inside Health Policy) ...After Pfizer's stock surged 14% following its Tuesday pact with the Trump administration -- a sign that investors see little risk to profits from the new pricing terms that are yet to be fully disclosed -- the deal is drawing criticism from both the Wall Street Journal editorial board and Make America Healthy Again supporters, albeit for very different reasons... Sub. Req’d

Trump Officials Plan to Test New Medicare Drug Pricing Rules

(10/3, Rachel Cohrs Zhang, Bloomberg Law) ...A new regulatory pilot project from the US Centers for Medicare and Medicaid Services is under review at the White House budget office, suggesting that the Trump administration is seeking to take regulatory action against drugmakers even as it strikes deals with individual companies. There are no details about the policy CMS plans to test, titled the "Guarding US Medicare Against Rising Drug Costs" pilot, including what drugs or companies could be impacted. Regulatory pilot projects help the government determine if a new regulation will save money, allowing it to experiment with rules before implementing them widely... Sub. Req’d

FDA Seeks To Encourage Onshoring With ANDA Prioritization Pilot

(10/6, Dave Wallace, Generics Bulletin) ...The FDA has launched a new pilot program to prioritize the review of ANDA products that are manufactured and tested in the US. The scheme builds on the FDA's PreCheck program, which aims to accelerate the establishment of new pharma manufacturing facilities in the US. Multiple off-patent players have already announced localization initiatives, with investments already running into billions of dollars... Global Sub. Full

FDA Launches Generics Pilot Program, Advances Facility PreCheck Proposal in Bid to Incentivize US Drug Manufacturing

(10/3, Fraiser Kansteiner, Fierce Pharma) ..."Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production," George Tidmarsh, M.D., Ph.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement...While finding locally sourced APIs might be easier said than done, the program does focus on incentivizing production of the drugs that make up the vast majority of the medications patients take in the U.S... Full

FDA Pilot Program Creates New Path for Faster Regulatory Review of Generic Drugs

(10/5, Frank Vinluan, MedCity News) ...To qualify for the new pilot program, a drugmaker must conduct any required bioequivalence testing in the U.S. Also, the product must be made in the U.S. using exclusively domestic API sources. Documentation showing a drug meets these requirements must be included in a company's request seeking this new type of priority FDA review...The agency did not quantify how much faster generic drugs will be reviewed under the new pilot program. But domestic production is a key component of another FDA pilot program focused on branded products... Full

Focus: US Health Secretary Kennedy Speeds Autism Drug With GSK Help

(10/6, Patrick Wingrove, Maggie Fick, Julie Steenhuysen, Reuters) ...The FDA's unusual move will allow it to bypass a lengthy label update for generic versions of the drug, leucovorin, or new clinical trials, a tactic academics, lawyers and doctors questioned. A GSK spokesperson told Reuters it plans to complete the new use application for the branded version of leucovorin "as quickly as possible." Once the British drugmaker does that work, the FDA would normally take about four to six months but could process the request even faster, said Giuseppe Randazzo of the Association for Accessible Medicines, a generic medicines lobby group... Full

Onshoring Could Threaten the Resilient Supply Chain for Biosimilars and Generics

(10/6, Gillian Woolett, STAT+) ...While encouraging market players to build more manufacturing facilities in the U.S. arguably counts toward fostering competition, that is only when the conditions for doing so are truly favorable. The industry will invest its judgment and resources into making medicines in America, just like any other goods, because it makes sense to contribute locally to a competitive market that values its products, and has the qualified people to make them. Onshoring should not be encouraged for onshoring's sake. Forcing such moves through tariffs encourages inefficiencies, as it protects U.S.-based companies from real competition. That ultimately hurts patients, as tariffs on pharmaceuticals are bound to immediately raise prices for the medicines they need now... Sub. Req’d

Sen. Rick Scott Asks Trump Admin to Secure U.S. Supply Chain and Address America's Overreliance On Foreign Generic Drug Imports in 232 Investigation

(10/3, Rick Scott Florida's U.S. Senator) ...In his letter, Senator Scott notes the vulnerabilities and national security concerns of America's overreliance on adversaries like Communist China, which supplies upwards of 80% of active pharmaceutical ingredients in generics, and emphasizes the need for domestic production to ensure Americans' access to safe, reliable medicines. Senator Scott has been sounding the alarm on America's dangerous overreliance on foreign-manufactured generic drugs and how it jeopardizes both our national security and public health with a recent hearing of the U.S. Senate Special Committee on Aging and letter to Food and Drug Administration (FDA) Commissioner Martin Makary on the FDA's oversight of foreign drug manufacturing and importation... Full

Aging Panel Probes Enforcement Exemptions For Foreign Drugmakers

(10/3, Jessica Karins, Inside Health Policy) ...Leaders of the Senate Special Committee on Aging have asked FDA Commissioner Marty Makary to provide more information on exemptions granted to foreign drug manufacturing facilities from FDA enforcement policies, saying exemptions may have allowed the continued import of drugs despite safety and human rights concerns. The committee will also dig into the issue at a hearing next week titled, "Bad Medicine: Closing Loopholes that Kill American Patients."... Sub. Req’d

Researchers Recommend US Diversify Antibiotic Imports to Reduce Shortages

(10/3, Jeff Craven, Regulatory Focus) ...The United States tends to source finished dosage forms of antibiotic products from many different countries while relying on China for a majority of imported active pharmaceutical ingredients, according to recent research published in JAMA Health Forum. The researchers said improving domestic production and diversifying antibiotic supply sources "are critical steps that depend on a detailed understanding of antibiotic supply chains and global sources."... Full

Carve Away: D.C. Circuit Keeping the "Chubby Label" Carve-Out Alive

(10/6, Sara W. Koblitz, FDA Law Blog) ...Legal challenges to the carve-out are not new: The GSK v. Teva saga, followed by the Amarin v. Hikma litigation, made clear that Reference Listed Drug sponsors are no fans of the carve-out. But the recent highly-publicized challenges have originated from patent law, essentially taking the position that ANDA manufacturers induce infringement by promoting their carved-out generics as AB-rated or therapeutically-equivalent to the fully-labeled Reference Listed Drugs (even though such a generic is only AB-rated insofar as it is labeled the same as the brand-name drug). While we're still waiting to see if the induced infringement theory renders the carve-out effectively dead (and whether legislation will revive it), the D.C. Circuit recently had the opportunity to take on an Administrative Procedure Act (APA) challenge to the carve-out as one of the first suits challenging FDA's authority after Loper Bright... Full

States Fed Up With High Drug Prices Are Cracking Down

(10/5, Peter Whoriskey, The Washington Post) ...With the advent of state price controls, the pharmaceutical industry finds itself besieged on multiple fronts. After decades of strong profits, drug companies are contending with President Donald Trump's recent demands for lower prices and entering forced negotiations over Medicare drug prices, the centerpiece of a cost-cutting initiative by the Biden administration. "What we're seeing is politicians and the public want a win here," said Benjamin Rome, a health policy researcher and an assistant professor at Harvard Medical School who has consulted with Colorado's Prescription Drug Affordability Review Board. "They want evidence that something is being done to address high drug prices."... Sub. Req’d

AstraZeneca, Daiichi Sankyo Report Phase 3 Win for Datroway in Triple Negative Breast Cancer

(10/6, Ayisha Sharma, Endpoints News) ...AstraZeneca and Daiichi Sankyo's successor to their blockbuster drug Enhertu has cleared the first of several registrational studies in triple-negative breast cancer that could position it for a key label expansion. Datroway, also known as Dato-DXd, met the dual primary endpoints of overall survival and progression-free survival in a Phase 3 trial called TROPION-Breast02, according to a Monday release... Sub. Req’d

EMA Accepts Biosimilar Application for Alvotech's Omalizumab Drug

(10/6, StreetInsider.com) ...The European Medicines Agency accepted a marketing authorization application for AVT23, a proposed biosimilar to Xolair (omalizumab), developed by Alvotech (NASDAQ: ALVO) in collaboration with Advanz Pharma. AVT23 targets omalizumab, a humanized monoclonal antibody used to treat severe persistent allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps. Xolair is currently marketed by Novartis AG... Full

Gedeon Richter Gains FDA Nod for Biosimilar Products

(10/6, The Pharma Letter) ...Hungary's largest drugmaker Gedeon Richter has received approval for its biosimilar products for the first time following a multi-agency inspection conducted by the US Food and Drug Administration. During the approval process, the FDA conducted a total of nine on-site inspections: at five clinical trial sites, three support laboratories – including Richter's pharmacokinetic laboratory – and at the Debrecen site, where the agency inspected the biotechnological active ingredient production, sterile preparation plant, development activities and support functions over a two-week period...The newly-approved denosumab biosimilars – Enoby and Xtrenbo – will soon be available in the USA exclusively from Hikma Pharmaceuticals, the company noted... Sub. Req’d

Hikma, Celltrion Partner to Expand Biosimilar Reach in MENA

(10/6, Petra) ...The new agreements, announced Monday, pave the way for the launch of six biosimilars, expanding access to cutting-edge treatments in key therapeutic areas, including oncology, immunology, ophthalmology, orthopedics, and allergy care. Under the partnership, Hikma will hold exclusive marketing rights across MENA markets, while Celltrion will handle development, manufacturing, and supply... Full

AEON Biopharma Sets FDA Meeting To Advance Botox Biosimilar ABP-450

(10/6, Dean Rudge, Generics Bulletin) ...AEON Biopharma is preparing to meet with the FDA on Nov. 19, 2025, to discuss its ABP-450 proposed biosimilar to the mega-blockbuster Botox (onabotulinumtoxinA). The meeting will focus on AEON's 351(k) biosimilar pathway analytical plan, specifically its comparative analytics and initial similarity data for ABP-450, also known as prabotulinumtoxinA. Meanwhile, the meeting is crucial for aligning with the FDA on the necessary analytical work that will support a biosimilar application... Global Sub. Full

‘Chubby Labels?': D.C. Appeals Court Finds MSN's Generic Entresto Approval Was Lawful

(10/6, Dean Rudge, Generics Bulletin) ...The D.C. Court of Appeals has upheld the FDA's approval of MSN Laboratories' generic version of Entresto, ruling that the FDA acted within its legal authority. The court found that MSN's label modifications did not violate regulations, even as Novartis challenged the safety and effectiveness of the altered dosing regimen and active ingredients. The ruling emphasized that making slight wording changes that included rewording and adding text rather than simply deleting it – becoming known colloquially as ‘chubby labels' – was permissible under FDA guidelines for drugs with different manufacturers... Global Sub. Full

Eli Lilly to Invest Over $1 Billion in India to Expand Manufacturing Capacity

(10/6, Rishika Sadam, Reuters) ...Eli Lilly will invest more than $1 billion in India in the coming years to boost manufacturing and supply through local drugmakers, the company said on Monday, as it seeks to tap into skilled workforce to bolster its global manufacturing expansion. The collaborations aim to increase the availability of Lilly's key drugs, including those for obesity, diabetes, Alzheimer's, cancer and autoimmune conditions, the company said... Full

Costco to Sell Ozempic and Wegovy at a Large Discount for People Without Insurance

(10/3, Kaan Ozcan, Marina Kopf and Anne Thompson, NBC News) ...Novo Nordisk, the company that makes Ozempic and Wegovy, announced Friday it will be selling the prescription injectable pens at the warehouse chain's pharmacies. A four-week supply of the weight loss drug will cost $499 out of pocket. Novo Nordisk already sells the monthly supply for $499 at its direct-to-consumer website, and it offers the same discount through CVS and Walmart..."We want to make sure we offer the real, authentic Wegovy and Ozempic where patients seek care," David Moore, president of Novo Nordisk U.S., told NBC News. "We know that Costco is a trusted brand."... Full

Pharma Has Paid Billions in Opioid Settlements — But Not to Many Victims' Families

(10/4, Marisa Iati, The Washington Post) ..."Fixing it doesn't mean paying someone whose kid died 20 years ago," said Jonathan J.K. Stoltman, director of the Opioid Policy Institute, which aims to help people affected by addiction. "It means making sure someone else's kid doesn't die this year." The states argued in their lawsuits that entire populations were affected by overprescribing, not that companies caused specific deaths. So to state officials, the settlements were intended to keep opioids from causing more harm. Some advocates against victim compensation also argue that it would be impossible to create a fair distribution system for families and that money can't truly ameliorate the damage done... Sub. Req’d

US Tariffs And Geopolitical Tensions Push EU To New Trade Routes And Infrastructure Growth

(10/3, Francesca Bruce, Pink Sheet) ...Global shifts towards protectionism mean greater uncertainty for European pharmaceutical companies. The EU is trying to counter tensions with the US by opening up new markets with which companies can do business. Investments in health care systems and capital infrastructure can make markets more attractive to international companies... Global Sub. Full

Big Pharma's 'Brexit' Draws Call for Anticompetition Probe from Advocacy Groups: Report

(10/3, Zoey Becker, Fierce Pharma) ...The groups pointed to a "pattern" of paused U.K. investments, Balanced Economy explained in a Sept. 29 press release. Together, AstraZeneca, Lilly and Merck have paused over £1.5 billion ($2 billion) in U.K. investments over the past year, the advocacy organizations pointed out. "We believe there is a significant risk that a number of companies, in partnership with their representative trade body, the Association of the British Pharmaceutical Industry (ABPI), have been making and timing their actions and announcements in a coordinated manner to align business strategies for anti-competitive purposes," the groups note in the letter... Full

With Much to Win (or Lose), Drugmakers and European Officials Bear Down On Major Policy Overhaul

(10/6, Andrew Joseph, STAT+) ...After years of work, European officials are nearing the finish line on the biggest shakeup to European pharmaceutical policy in decades, with major impacts on everything from how quickly new medicines are rolled out across the continent to how willing drugmakers are to invest in the E.U...But a key focus of the legislation — and a key point of contention — centers on how long drugmakers have the market to themselves for their products before generic competition is allowed. Some advocates have argued that the period should be shortened to ease access to medicines both for patients and for countries whose budgets are constrained, but drugmakers have warned that if policies are too restrictive they may take their business, and their products, elsewhere... Sub. Req’d

Indian Pharmaceutical Alliance Appoints Zydus Lifesciences MD Sharvil Patel as New President

(10/3, Rica Bhattacharyya, The Economic Times) ...The Indian Pharmaceutical Alliance (IPA) has appointed Sharvil Patel of Zydus Lifesciences as its new President, with Glenn Saldanha of Glenmark as Vice President. This leadership transition occurs as the industry navigates GST reforms and strengthens its global position in specialty medicines. The new team aims to drive innovation, patient access, and quality healthcare solutions... Full

US Tariff Threats Push Indian Pharma to Diversify Beyond Generics, American Market

(10/6, The Economic Times) ...The powerful lobby of 23 leading Indian drug makers - they account for most of the roughly $10 bn generic drugs exported to the US - noted that American medicine security won't be strengthened by the 100 per cent punitive tariffs on imported branded and patented pharma products. Instead, it risks driving generics out of the US market. But while the tariffs were to kick in from October 1, no executive orders have followed. Trump, instead, struck a deal with Pfizer and a few others to supply meds at rates similar to those in Europe... Full

New Pharma R&D Scheme Helpful Only for Incremental Products: Experts

(10/5, Manu Kaushik, Financial Express) ...The recent overhaul of the Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP) scheme by the government might be insufficient to create an ecosystem for development of novel drugs in India, industry experts feel. Development of a new drug molecule (new chemical entity) costs anywhere between $2-4 billion. With an estimated outlay of Rs 5,000 crore, the scheme falls short of the requirement, even taking into consideration that the bulk of the funds must come from the drug companies, as equity or debt, they said... Full

Editorial: Just the Booster Pill Indian Pharma Needs

(10/5, The Economic Times) ...The powerful lobby of 23 leading Indian drug makers - they account for most of the roughly $10 bn generic drugs exported to the US - noted that American medicine security won't be strengthened by the 100% punitive tariffs on imported branded and patented pharma products. Instead, it risks driving generics out of the US market. But while the tariffs were to kick in from Oct 1, no executive orders have followed. Trump, instead, struck a deal with Pfizer and a few others to supply meds at rates similar to those in Europe... Full

India Begins Criminal Action Against Cough-Syrup Maker Linked to Deaths of 14 Children

(10/6, Rishika Sadam, Reuters) ...Police in India have launched criminal action against a maker of cough syrup whose product was found to contain dangerous levels of a toxic chemical, after the deaths of 14 children suspected to have consumed contaminated medicine. Known as the "pharmacy of the world", India has faced scrutiny for the quality of its pharmaceutical exports, with its cough syrups being linked to child deaths in Cameroon, Gambia and Uzbekistan over the past few years. A sample of the syrup, 'Coldrif', among 19 medicines tested after the deaths in Madhya Pradesh state, contained 46.28% diethylene glycol, far exceeding a permitted level of 0.1%, a state drug laboratory said in a report seen by Reuters... Full

India and Russia Pharma Ties Deepen as Putin Calls for Boost in Indian Drug Imports

(10/6, The Pharma Letter) ...With pharmaceuticals already representing a $5 billion surplus in India's favor, the Kremlin's push signals a major opportunity for Indian drugmakers to expand their footprint in Russia's pharmaceutical market, reports The Pharma Letter's India correspondent. The announcement coincides with a high-level bilateral meeting held in India late last month between JP Nadda, Health Minister and Dmitry Nikolaevich Patrushev, Deputy Prime Minister of the Russian Federation. The talks mainly focused on strengthening cooperation in drug manufacturing, research, and public health initiatives, aiming to improve affordability and access to essential medicines across both nations... Sub. Req’d

China Unlocks $15 Billion Market for Indian Pharma with Tariff Cut

(10/6, The Pharma Letter) ...In what is being termed a major boost to India's pharmaceutical export industry, China has announced the immediate removal of its 30% import duty on Indian pharmaceutical products. The move is expected to unlock a $15 billion market for Indian drugmakers, as the Chinese policy shift is expected to redirect up to 30% of India's US-bound pharma shipments toward China...With rising costs in the US market, China now offers a lucrative alternative, potentially reshaping India's global pharma strategy, he said, emphasizing that this will not only deepen India-China trade ties but also fuel India's economic growth and reinforce its pivotal role in the global healthcare ecosystem... Sub. Req’d

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