Tuesday, July 8, 2025

Biden's Drug Price Plan Still Flawed Under Trump, Opponents Say

(7/8, Nyah Phengsitthy, Bloomberg Law) ...The pharmaceutical industry is criticizing the Trump administration's plan for carrying out a critical round of Biden-era drug price negotiations that doubles down on actions they've resisted since the program began...Among the industry's concerns is the government's plan for bringing Part B into the program—a significant move as the Medicare plan covers treatments typically administered in a doctor's office and includes different pricing dynamics and stakeholders in the supply chain...PhRMA and the Biotechnology Innovation Organization shared concerns about the oversight of Part B drugs in Medicare Advantage plans, spillover effects into the commercial market, and access barriers that Part B beneficiaries face... Full

US Lobby Groups Urge Tariff Retaliation Against Australia's ‘Socialised Medicine'

(7/7, Tom McIlroy, The Guardian) ...Some of the most influential lobby groups in Washington are pushing the US to retaliate against Australia's treatment of American exporters, pointing to drug approvals and domestic manufacturing incentives as proof of unfair "freeloading"...Chamber of Commerce vice-president John Murphy has used the review to criticise slow approval times and rejection rates for new drug applications to Australia's $18bn Pharmaceutical Benefits Scheme...Murphy said Australia had no system to notify drug patent holders of applications by rival companies for generic drugs entering the market, meaning public announcements sometimes prompted court action... Full

California Targets Drug Price Middlemen After Congress Balks

(7/8, Andrew Oxford, Bloomberg Law) ...The state Assembly Health Committee is expected to approve Tuesday a measure that would prohibit a range of business practices used by pharmacy benefit managers, which legislators contend are driving up drug prices and running independent pharmacies out of business. Just a few PBMs—CVS Caremark, Cigna Corp.'s Express Scripts, and UnitedHealth Group Inc.'s OptumRx—control the vast majority of the $600 billion market across the US... Sub. Req’d

The Supreme Court Passed On a State PBM Case. Lawyers Say a Broader Legal Fight is Brewing

(7/7, Nicole DeFeudis, Endpoints News) ...The justices left in place an appellate court decision against certain provisions in an Oklahoma law that imposed requirements on PBMs and their pharmacy networks. The case could have offered clarity on an issue that has triggered a wave of litigation. But instead, lower courts in other circuits are left to navigate a complex web of cases as states continue to crack down on the entities that have come under fire for their role in drug pricing... Sub. Req’d

Study Reveals the U.S. Pharmaceutical Firms with the Most FDA Recalls

(7/7, Healthcare Packaging) ...New study identifies the pharmaceutical firms with the most drug recalls in the U.S. from 2012-2024. Aidapak Services leads with 538 total recalls, while King Bio Inc. tops the list for most hazardous Class I recalls with 465 dangerous violations. The data reveals significant fluctuations in pharmaceutical recall activity over the past 13 years. 2019 stands out as the worst year on record... Full

FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say

(7/7, Victoria Malis, Katherine Dailey, Sadie Leite, Debbie Cenziper and Megan Rose, ProPublica) ...Inspectors charged with safeguarding America's drug supply say they are reeling from deep cuts at the Food and Drug Administration despite promises by the Trump administration to preserve the work of the agency's investigative force... Full

Inside the Collapse of the F.D.A.

(7/8, Jeneen Interlandi, The New York Times) ..."You have to have a deep cynicism about what these workers are doing to believe that fewer of them is better," Peter Lurie, a doctor who was an associate commissioner during the Obama administration, told me, as more layoffs were announced one early spring afternoon. Most offices were understaffed, almost as a rule, he said. The ones that weren't tended to be paid for by user fees (money that drug and device makers give the agency to cover the cost of reviewing their products). But neither DOGE members who counted those layoffs as a cost-cutting win nor the health secretary himself seemed aware of this fact... Sub. Req’d

Mark Ratner Joins AAM to Lead Government Relations

(7/7, AAM) ..."We are thrilled to welcome Mark to the AAM and Biosimilars Council team," said John Murphy III, President and CEO of AAM. "He has already hit the ground running and will be a key leader in our advocacy efforts to bring about common-sense reforms to ensure sustainable and affordable generics and biosimilar medicines for patients across the country."... Full

Southwest Airlines Accuses Drugmakers of Price-Fixing Conspiracy in New Lawsuit

(7/7, Mike Scarcella, Reuters) ...Southwest Airlines has sued a group of drugmakers in U.S. court for allegedly participating in a price-fixing conspiracy that caused the airline to overpay for purchases of hundreds of millions of dollars in medications for employees. Southwest alleged it was overcharged by generic drugmakers including Sandoz, Teva and Sun starting in May 2009. The lawsuit, filed in the federal court in Philadelphia and unsealed on July 3, said the companies violated antitrust law by coordinating on pricing... Full

Celltrion Launches Prolia, Xgeva Biosimilars in US, Turning Up Heat On Amgen and Sandoz

(7/8, Kim Ji-hye, Korea Biomedical Review) ...Stoboclo and Osenvelt arrive with a 5 percent discount to Amgen's Prolia and Xgeva, which racked up $6.6 billion worldwide last year, two-thirds of it in the U.S. Celltrion is distributing the drugs directly through its U.S. subsidiary, following the same strategy used for its infliximab, adalimumab and ustekinumab biosimilars... Full

Apotex Follows Biocon With Canadian Biosimilar Aflibercept Launch

(7/7, Dean Rudge, Generics Bulletin) ...Apotex has launched its first ophthalmic biosimilar, Aflivu (aflibercept), approved by Health Canada as a competitor to Bayer/Regeneron's Eylea 2mg. This follows Biocon's Yesafili approval just days earlier, marking a significant step in the introduction of Eylea biosimilars in Canada. Apotex previously settled a patent infringement lawsuit with Bayer, allowing launch no sooner than July 2025... Global Sub. Full

Zydus Trastuzumab Suit Dismissed In India For ‘Illusion Of Cause Of Action'

(7/8, Dean Rudge, Generics Bulletin) ...A Bombay High Court in India has dismissed Zydus Cadila's pre-emptive lawsuit against Roche regarding its Herceptin biosimilar, Vivitra. Zydus filed this suit nearly a decade ago, fearing legal actions from Roche due to similar cases with other Indian companies. The court stated the complaint provided an "illusion" of a real dispute, noting that it cannot be based on speculative fears of future legal obstruction... Global Sub. Full

Sagent, Qilu Partner to Commercialise Complex Injectable Products in US

(7/8, Pharmaceutical Business Review) ...Through this partnership, Sagent will gain sole rights to commercialise a select portfolio of Qilu's complex injectable products in the US. These products encompass high-impact therapeutic areas, addressing unmet patient needs across the US healthcare landscape. According to Sagent, the combined total addressable market for these products is expected to be more than $4.5bn, indicating "strong" demand across its key therapeutic areas... Full

Biosimilar Adoption Is Accelerating and this Name Is in the Spotlight

(7/7, Sam Boughedda, StreetInsider.com) ...In a proprietary physician survey conducted by FirstWord and cited by Barclays, clinicians identified "simplified payer and reimbursement pathways" as the single most influential factor in encouraging biosimilar prescribing over branded drugs. The findings are said to suggest that while nearly half of the 66 surveyed specialists remain hesitant due to concerns about long-term efficacy and safety, 60% foresee moderate to strong growth in uptake due to the U.S. FDA's recent biosimilar approvals and growing awareness. Barclays noted that "Sandoz is a likely key beneficiary" of this trend... Sub. Req’d

The Stelara Biosimilar Price War: How PBM-Affiliated Private Labels Are Reshaping the Market

(7/8, Adam J. Fein, Ph.D., Drug Channels) ...Private label strategies, aggressive pricing, and exclusive formulary deals have transformed what might have been a slow-crawling biosimilar introduction into a full-on pricing war. As with Humira, the reality of biosimilar economics is far messier—and more revealing—than the policy narratives suggest. In this post, I examine how the major PBMs—and some of the smaller ones—are handling Stelara biosimilars, what's changed since the Humira experience, and why their strategies reflect the growing dominance of private-label rebating schemes... Full

Sun Pharma Says Working Towards Full Regulatory Resolution at 3 Plants Facing USFDA Action

(7/8, Press Trust of India) ...Sun Pharma focuses on compliance across its manufacturing units. It aims for full regulatory resolution at facilities facing USFDA action. The company has completed CAPA implementation at Halol. CAPA implementation is in process at Mohali and Dadra. R&D investment is expected to be 6-8% of sales. The company anticipates mid to high single-digit consolidated topline growth in FY26... Full

EU and US Must Work ‘Intensively' to Get Tariff Deal Before Deadline

(7/8, Cate McCurry, The Independent) ...Irish deputy premier Simon Harris said the pause is a "clear indication" that President Trump understands the need to have a trade deal in place..."I do want to flag I am concerned in relation to the issue of pharma. I think there's a lot of work to be done here in relation to pharma. We obviously have a very big pharma sector in this country. We've been a very good home to the pharma industry. They need access to the European Union, a market of more than 460 million people. In my conversations with the Trump administration, with Secretary (Howard) Lutnick, I've made this point that there is a way forward that could be good for the EU and good for the US and pharma."... Full

Swiss Inaction Threatens Global Antibiotic Development Push

(7/8, Jessica Davis Plüss and Pauline Turuban, Swissinfo.ch) ...Global health experts have long warned that resistance to antimicrobials, including antibiotics, is a slow-moving crisis with deadly consequences...Despite these warnings, few companies are developing new antibiotics based on a basic calculation: antibiotics are expensive to develop but generate little profit. A new drug can take 10–15 years and over $1 billion (CHF790 million) to develop, but antibiotics are expected to be cheap and used sparingly to prevent resistance. This economic mismatch has led public health experts to call for new purchasing models... Full

Snapshot Of India's Pharma Manufacturing Network Amid ‘Trumponomics'

(7/7, Anju Ghangurde, Generics Bulletin) ...Pharma's manufacturing network faces unprecedented strain amid geopolitical tensions, US tariff threats, supply chain disruptions, ongoing wars and fragile ceasefires...Against this backdrop, Generics Bulletin sister publication Scrip culled data from multiple sources including company annual reports, presentations and industry analyses and studies to provide a snapshot of where leading Indian pharma firms currently make their medicines, the markets serviced, API production hubs, and the contribution of exports to revenues... Global Sub. Full

As Chinese-Developed Drugs Draw U.S. Interest, A Regulatory Chill Threatens to Dampen New Investment

(7/7, Brian Yang, STAT+) ...In recent years, a growing number of Chinese biotech companies have moved to license their drug candidates out to new venture-backed startups in the U.S., but that approach may fall out of favor. As these biotech companies draw more multinational interest in their assets, many are reconsidering whether to pursue direct, asset-based licensing deals...The shift could alter the global biotech ecosystem, potentially reducing the flow of promising early-stage assets from China to Western markets, while simultaneously strengthening China's domestic biotech capabilities and global competitive position... Sub. Req’d

Korea Pre-Review Consultations Help Accelerate R&D

(7/8, Jung Won Shin, Pink Sheet) ...According to an official analysis, 64% of products undergoing pre-regulatory review consultations in South Korea over the past few years experienced accelerated development. The number of products undergoing such consultations, launched in 2020 to expedite regulatory processes for high-need products, surged to 101 last year from just 18 in 2022. Of the 133 drugs and biologics in the analysis, the largest proportion (35%) were still in early development (toxicity testing). Drug ministry programs to expedite innovative product reviews plan to select 18 drugs/biologics and six medical devices this year... Global Sub. Full

What Pharma Needs To Know About Vietnam's Drug Registration Reforms

(7/7, Neena Brizmohun, Pink Sheet) ...Circular No. 12/2025/TT-BYT came into effect in Vietnam on July 1, introducing sweeping new regulations on registering medicines in the country. The new rules promise to simplify both the dossier requirements for obtaining marketing authorization, and reduce the processing time. Companies have been advised to familiarize themselves with the new requirements... Global Sub. Full

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