Thursday, February 20, 2025

Stabilising Europe's Generic Medicine Supply

(2/20, Catherine Eckford, European Pharmaceutical Review) ...Ahead of the Critical Medicines Act anticipated in 2025, Teva's report offers policy recommendations to mitigate the economic pressures risking generic medicine availability in Europe..."Patients depend on reliable access to affordable, high-quality treatments, but the ongoing consolidation of suppliers and withdrawal of critical medicines threatens this access. Addressing the pressures on generic medicine manufacturers is essential to protecting patient care and ensuring the long-term sustainability of Europe's healthcare systems. For critical generic medicines it is even more important that a reliable, diversified supply network is in place," explained Michal Nitka, Senior Vice President, Generics Head Europe & OTC Global Head at Teva... Full

Lupin Shifts Its Focus To Complexity With Biosimilars And Specialty Plans On Horizon

(2/19, Urte Fultinaviciute, Generics Bulletin) ...As described by [Lupin's CEO Vinita Gupta], Lupin's strategy will focus on smaller and less competitive biologics. "Our focus is very much going to be in limited-competition products, where we're going to be in the first wave, where we can be one of two [or] one of three. That is the kind of focus that we will have from a portfolio standpoint. It will be a fairly selective number of products that we will pursue," she noted... Global Sub. Full

FDA Approves Generic Lenalidomide Capsules in Multiple Strengths

(2/19, Rose McNulty, AJMC) ..."Our ability to execute and continuously launch complex products is expanding our portfolio of affordable medicines and driving the sustainable growth of our business," Andy Boyer, executive vice president and chief commercial officer of affordable medicines at Amneal, said in a statement. "Mesalamine is a difficult to make product with a limited number of suppliers, and this approval highlights the strength of our R&D capabilities. Additionally, the approval of lenalidomide represents another key product approval in a large market that will be a future growth driver for us."... Full

Formycon Presents Clinical Data on Ustekinumab Biosimilar FYB202 at the ECCO Congress in Berlin

(2/10, Formycon) ...Formycon AG will present an overview of the comparative data of the ustekinumab biosimilar FYB202 at this year's Congress of the European Crohn's and Colitis Organisation, taking place in Berlin, Germany, from February 19 to 22, 2025. The poster presentation summarizes the clinical phase I and phase III study results and is complemented by advanced analytical laboratory data demonstrating the comparability of FYB202 with the reference product Stelara... Full

Generic Drug Suppliers Weigh in On Predictable, Unpredictable Category Impact

(2/19, Debby Garbato, Drug Store News) ...In 2025, the number of generic drug manufacturers gaining FDA approvals and launching biosimilars and GLP-1 drugs should significantly increase, along with those companies developing generics in other promising areas. But some factors are beyond suppliers' control, including possible tariff increases, pending legislation and global warfare. Ongoing price erosion and supply chain problems could also pose challenges... Full

Employer Plans, Private-Label Biosimilars, Little Transparency

(2/19, F. Randy Vogenberg, PhD, Biosimilars Review & Report) ...Employers can wield tremendous leverage in optimizing biosimilar uptake, but they have remained relatively disengaged to date. The successful record of biosimilar competition lowering biologic drug costs can be far better supported by self-insured employers in the US. To do so, employers need to think more deeply about their pharmacy benefit management (PBM) options and decision making, and contracting from a transparent financial perspective... Full

Celltrion's Phase 3 Study Confirms Interchangeability Between Yuflyma and Humira in Treating Plaque Psoriasis

(2/20, Lee Han-soo, Korea Biomedical Review) ...Celltrion said that the results of its phase 3 trial for Yuflyma (ingredient: adalimumab), a biosimilar referencing AbbVie's Humira, confirmed that the biosimilar is interchangeable with the originial in treating severe plaque psoriasis. The study has been published in the SCIE-indexed international journal Advances in Therapy... Full

All Generic Drugs Are Not Equal, Study Finds

(2/19, Jeff Grabmeier, Ohio State News) ...Generic drugs manufactured in India are linked to significantly more "severe adverse events" for patients who use them than equivalent drugs produced in the United States, a new study finds...The results show that all generic drugs are not equal, even though patients are often told that they are, said John Gray, co-author of the study and professor of operations at The Ohio State University's Fisher College of Business. "Drug manufacturing regulation, and therefore quality assurance practices, differ between emerging economies like India and advanced economies like the United States," Gray said. "Where generic drugs are manufactured can make a significant difference."... Full

Study Links India-Made Generic Drugs With 54 Pc More Severe Adverse Outcomes Than US-Made Ones

(2/20, Press Trust of India) ...The researchers looked at 2,443 generic drugs made in the US and emerging economies. About 93 per cent of generic drugs from emerging economy countries are made in India, they said. The team compared the frequency of adverse events reported for generic drugs made in India with that of adverse events reported for the equivalent generic drugs made in the US. "The predicted number of severe adverse events for generic drugs made in emerging economies is 54.3 per cent higher than the number of severe adverse events for the equivalent generic drugs made in advanced economies," the authors wrote... Full

How Much Weight Loss Is Too Much? Pharma Is Pushing the Limit with New Obesity Drugs

(2/20, Elaine Chen, STAT) ...Some doctors fear that this intense focus on weight loss is not in patients' best interests. The obesity treatment revolution sparked by Wegovy and Zepbound has been transformational for countless patients, they say, but a fixation on more and more weight loss is pushing the field into risky territory... Full

Change Healthcare Data Breach: Industry 'Not Fine' 1 Year Later

(2/19, Lauren Berryman, Modern Healthcare) ...The industry continues to grapple with the aftermath of the breach of UnitedHealth Group's technology subsidiary, which exposed data on 190 million consumers. Core functions, including claims processing, prescription management, payment, prior authorization and insurance verification froze after UnitedHealth disconnected systems Feb. 21, 2024, following the hack by ransomware group BlackCat... Sub. Req’d

US Tariffs: With 50% Of US Generics From India, Industry Ponders If MAHA Will Trump MAGA

(2/20, Vibha Ravi, Pink Sheet) ...US President Trump's plan for a "25% or higher" tariff on pharmaceuticals promises to have a far-reaching impact, from higher prices and drug shortages to increased onshoring of manufacturing in the US. Is MAGA worth the chaos it might create for MAHA? The Indian industry shares its views... Global Sub. Full

Celltrion Offers Update On US Tariffs Strategy

(2/20, Dave Wallace, Generics Bulletin) ..."As previously mentioned," Celltrion said, "pharmaceutical tariffs that could lead to drug price increases are showing a policy direction that directly contradicts president Trump's earlier stance, which showed notable institutional efforts to lower drug prices."...In the short term, the firm said it had "already completed pre-emptive measures to minimize the impact of potential tariffs for 2025. As of the end of January, we have transferred approximately nine months' worth of inventory for our products scheduled for US sale in 2025. This ensures minimal impact on this year's US sales, regardless of whether drug tariffs are imposed."... Global Sub. Full

Pfizer CEO Says Opportunities with Trump ‘Clearly Outweigh' the Risks for Pharma

(2/19, Andrew Dunn, Endpoints News) ...Pfizer CEO Albert Bourla, the incoming PhRMA chair, concluded the PhRMA Forum with some of the day's strongest messaging in favor of President Donald Trump, describing him as a changemaker that brings both upsides and downsides...Bourla, who leads one of the world's largest vaccine businesses in Pfizer, provided one of the day's only direct mentions of Kennedy. "Do I think we can convince them to do something bold in vaccines with Kennedy in HHS? Probably not," Bourla said. "But do I think that we can convince them to do something very bold for cancer or for cardiovascular diseases with Kennedy in HHS? Absolutely I do."... Full

For Some 100 Critical Drugs, The US Supply Comes from One Factory in China

(2/19, Edward Fishman, The Boston Globe) ...Decades of globalization have left supply chains deeply entangled, making vulnerabilities hard to spot, much less mitigate. But with the right mix of policy and diplomacy, Trump can put the United States in a far stronger position... Sub. Req’d

PhRMA Releases Report Aligned With MAHA Ahead Of Meeting With Trump

(2/19, Gabrielle Wanneh, Inside Health Policy) ...A policy agenda also released by the lobby Tuesday recommends the Trump administration modernize FDA to fully harness the usefulness of artificial intelligence; correct the "pill penalty" and other facets of the Inflation Reduction Act that could thwart innovation; permit drug companies to maintain ongoing and future conditions placed on 340 pricing to combat discount duplicates and diversion; and delink the income PBMs make from the list price of prescription drugs, among other reforms to curb the negative impact of certain PBM practices on drug costs... Sub. Req’d

Drug Industry: Let Us Make Americans Healthy

(2/19, Lauren Gardner, David Lim, Politico: Prescription Pulse) ...Many of PhRMA's member CEOs are scheduled to meet with President Donald Trump at the end of this week, according to a source familiar with the meeting and granted anonymity to discuss the confab. Gilead CEO Daniel O'Day argued the drug industry is poised to help Kennedy make America healthier. "We can bring hope through new medicines and innovation. We can change the trajectory of disease with advancements in science," O'Day said at the event... Full

PhRMA To Meet With Trump This Week In First Talks

(2/19, Maaisha Osman, Inside Health Policy) ...The Pharmaceutical Research and Manufacturers of America (PhRMA) confirmed Tuesday (Feb. 18) that its leadership will meet with President Donald Trump this week, though Novo Nordisk told Inside Health Policy it will not attend. While details of the meeting remain undisclosed, it marks the first official gathering between the drug industry's top leaders and Trump since he took office in January... Sub. Req’d

Trump May Steer FTC's Drug-Pricing Agenda As He Takes Control Of Independent Agencies

(2/19, Maaisha Osman, Inside Health Policy) ...President Donald Trump issued an executive order Tuesday (Feb. 18) requiring independent agencies, including the Federal Trade Commission (FTC), to submit draft regulations, priorities and strategic plans to the White House -- a move giving the president direct influence over FTC's drug-price control agenda. While some experts question whether he has the legal authority to oversee agencies designed to operate independently, a former FTC general counsel tells Inside Health Policy that the order falls within the president's power under the Constitution's Take Care Clause... Sub. Req’d

'Health Insurance Companies Are Always Going to Need a PBM': CVS President Prem Shah

(2/19, Anjalee Khemlani, Yahoo! Finance) ...The drug industry's biggest lobbying firm, PhRMA, released its policy priorities for 2025 Tuesday, including, "Put patients before PBM profits by sharing negotiated savings directly with patients and holding PBMs and health plans accountable for limiting patient choices." That has spurred PBMs like CVS Caremark (CVS) to defend their companies' value in the overall healthcare system...CVS Health group president and executive vice president Prem Shah told Yahoo Finance that PBMs, used by a majority of Fortune 500 companies, endeavor to lower costs of branded drugs — yet just last month, pharma companies increased list prices on drugs by 4.5% compared to the prior year's price... Full

Mark Cuban: Pharma ‘Hates' PBMs, But Also ‘Afraid' to Quit Working With Them

(2/19, Angelica Peebles, CNBC) ...Billionaire Investor Mark Cuban sits down with Angelica Peebles to discuss convincing big pharma to move away from the PBMs and over to Cost Plus Drugs, his decision to sell the Mavericks and his thoughts on their recent player trade of Luka Doncic... Full

PhRMA CEO: 'Key Reforms Still Need to Be Enacted' for the Price of Drugs

(2/19, Angelica Peebles, CNBC) ...PhRMA CEO Steve Ubl discusses, PBM reform, the "pill penalty" with the administration and advocating for pharmaceutical products to be excluded from any new tariffs... Full

Insurers Push Back On Medicare and Medicaid Coverage for GLP-1s

(2/20, Maya Goldman, Axios) ...Health plans are lobbying the Trump administration to scrap a proposal dating from the final days of the Biden administration that would require Medicare and Medicaid to cover anti-obesity drugs, including GLP-1s, for weight loss...Insurers who administer Medicare and Medicaid benefits argue they'd end up having to pass the added cost to consumers in the form of higher premiums... Full

California Insulin Program Remains Over a Year Away to Market

(2/19, Andrew Oxford, Bloomberg Law) ...Vishaal Pegany, deputy director for the state's Office of Health Care Affordability, said clinical trials will begin soon for drugs under the delay-plagued program, but could not offer certainty when the drugs may reach the market to help the more than 3 million Californians with diabetes... Sub. Req’d

House Set to Approve Expansion of Drug Board's Authority to Lower Costs

(2/19, Danielle J. Brown, Maryland Matters) ...House Democrats beat back a series of Republican amendments on party-line votes Wednesday, setting up a final vote on a proposal to expand the authority of a state board created to lower prescription drug prices in Maryland. Del. Bonnie Cullison (D-Montgomery) defended House Bill 424, which would expand the authority of the Prescription Drug Affordability Board from drugs purchased by state health plans to drugs purchased by any drug provider in the state. She rejected GOP arguments that the board would set a limit on prices... Full

Pharmacy Benefit Managers Take a Hit in Pritzker Budget Speech

(2/19, Katherine Davis, Crain's Chicago Business) ...Gov. JB Pritzker is unveiling new legislation aimed at lowering prescription drug costs by targeting practices commonly used by pharmacy benefit managers, the middlemen of the pharmaceutical, insurance and pharmacy industries..."We share Governor Pritzker's objective to lower prescription drug costs in Illinois," [The Pharmaceutical Care Management Association] said in a statement today. "Unfortunately the governor's speech today missed the mark on the value that pharmacy benefit managers (PBMs) provide in Illinois. To be clear, the core mission of PBMs is to lower prescription drug costs and increase access to medications."... Sub. Req’d

IGBA Releases First Global Intellectual Property and Competition Report

(2/19, The International Generic and Biosimilars Medicines Association) ..."The report's findings highlight the urgent need to reinforce the balance in intellectual property and regulatory systems to address market abuses. Healthy competition requires clear guardrails, which is why we are taking a lead to raise awareness and invite conversation and action to rebalance innovation and access for the future", said IGBA Chair, Shinichiro Hirose... Full

Pharma Industry Wants Easier Access To England's Revamped NHS Data Sharing System

(2/19, Eliza Slawther, Pink Sheet) ...The pharmaceutical industry was not sufficiently involved in designing updates to England's health data infrastructure, leading to a "misalignment" between company needs and what is currently being delivered, according to the results of a survey by the Association of the British Pharmaceutical Industry... Global Sub. Full

Irish Pharma Could Escape Trump Tariffs

(2/19, John Burns, Irish Independent) ...Launching the agency's plan for the next five years, Michael Lohan said the "vast majority" of the €58bn worth of pharma products that leave Ireland for the US each year are intermediary, and face further processing there. While he would not comment on whether that meant the pharma exports could avoid the tariffs that President Trump is threatening, Mr Lohan said there is a question about what point in the supply chain the levies are applied... Full

Report Unveils Strategic Roadmap to Become a Global Pharma Export Hub by 2047

(2/20, Shardul Nautiyal, Pharmabiz.com) ...India is poised to solidify its position as a global pharmaceutical powerhouse, according to a report ‘Healing the World: A Roadmap for Making India a Global Pharma Exports Hub'...Report reveals pharma growth as an economic driver. The report aligns with India's broader economic goal of becoming a USD 30-35 trillion economy by 2047, with pharmaceuticals expected to be a key growth driver... Full

Biosimilars and the Need for a Policy Prescription

(2/20, Dinesh S. Thakur and Prashant Reddy T., The Hindu) ...At the core of the problem is the fact that India does not have a well thought-out regulatory law for biosimilars. It is crucial that the government gives this issue urgent attention because in a country like India, where much of healthcare costs are met out of pocket, the cost of medicine has a direct impact on the accessibility of medicine... Full

German Drug Makers High On Hopes for Germany's Next Government

(2/20, Magdalena Kensy, Euractiv) ...Germany's pharmaceutical industry is looking for the country's next government to give it a shot in the arm. Though Germany remains a powerhouse in the sector — which German scientists effectively invented more than a century ago — many in the business worry that the country is losing its edge amid thriving biopharmaceutical R&D in the US and China, where the industry benefits from substantial subsidies and less red tape... Full

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