Tuesday, April 22, 2025

Europe's Pharmaceutical Industry Wants More Clarity On ICH's Modeling Guideline

(4/21, Joanne S. Eglovitch, Regulatory Focus) ...Industry requests more modeling examples. The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Teva Pharmaceuticals Industries Ltd. wanted more examples of how different modeling approaches can be used in drug development. "It would be helpful if this ICH guideline provided detailed elaboration on the use of MIDD in specific therapeutic contexts, such as pediatrics, new indications based on similarities, and others," according to Teva's comments... Full

Alvogen Unit Appeals Court Loss Shielding Bausch Health's IBS Drug from Generics

(4/21, Alexis Kramer, Endpoints News) ...The drugmaker had argued the FDA should have granted it final approval because Teva's subsidiary Actavis forfeited its 180-day exclusivity period. Actavis hasn't actively pursued or obtained approval to market rifaximin tablets, even though it applied about 10 years ago, Alvogen said...The FDA's decision "comports with the clear text and structure" of the law and no forfeiture occurred because Actavis included the proper certifications in its application, the court said. Teva's Actavis is barred under a settlement agreement from entering the generic rifaximin market until January 2028, unless another applicant obtains approval and comes to market, according to Alvogen... Full

Samsung Bioepis Reevaluating Approach To Biosimilars

(4/22, Jessica Merrill, Generics Bulletin) ...VP and head of regulatory strategy and policy Gillian Woollett talked about the US biosimilar market and challenges that are leaving a void in the market. Streamlining biosimilar development requirements could halve the time and cost of development, she said, though reimbursement still needs to be addressed. One option the company might explore is developing branded biologics alongside biosimilars... Global Sub. Full

Polpharma Looks To Supercharge Biosimilar Development With Help Of Chime

(4/22, Dean Rudge, Generics Bulletin) ...According to the firms, the agreement will accelerate Polpharma's biosimilar program from investigational new drug application to commercial manufacturing, with a commitment to producing an eventual biologics license application to the US Food and Drug Administration. Meanwhile, Polpharma and Chime are also eyeing the potential to expand their global market presence through a planned launch in the EU, among other regions... Global Sub. Full

AstraZeneca, Daiichi Eye First-Line Breast Cancer Market After Enhertu's Early Phase 3 Win

(4/22, Elizabeth Cairns, Endpoints News) ...AstraZeneca and Daiichi Sankyo's Enhertu cut the risk of progression or death compared with the standard of care for first-line HER2-positive metastatic breast cancer, the companies said Monday. The finding could lead to the antibody-drug conjugate becoming the first new treatment in this setting for over a decade. And if approval in this population is granted, Enhertu will be a step closer to hitting the $5 billion annual peak sales target AstraZeneca has set for it... Full

US Patients Lose Access to Cheaper Weight-Loss Drugs as Market for Replicas Winds Down

(4/21, Hannah Kuchler, Financial Times) ...An industry association estimates 2mn patients were on compounded versions of weight loss drugs in the year to November 2024. Investors are watching closely to see how they respond and particularly whether they opt for Novo's Wegovy or the Lilly drug Zepbound instead... Sub. Req’d

Can Anything Threaten Novo and Lilly's Obesity Market Dominance?

(4/21, Amy Baxter, PharmaVoice) ...To help maintain market dominance, Novo and Lilly are taking a page from the pharma playbook for creating patent thickets. Novo, in particular, is taking these protections to new heights. The Danish pharma company has filed 320 patent applications for its three semaglutide drugs and has been granted 154, according to I-MAK...These patent strategies have made it unclear exactly when generic semaglutide and tirzepatide could pose a threat. A generic version of liraglutide, a GLP-1 medication for diabetes under Novo's brand name of Victoza, was launched last year by Teva Pharmaceuticals after the pharma company reached a settlement agreement with Novo. Generic drugmakers could also come after Novo and win rights to launch generic semaglutide sooner than the date its patent extensions lapse... Full

Americans Spent $71 Billion On GLP-1 Drugs in 2023

(4/21, Hannah Docter-Loeb, The Washington Post) ...Americans spent an estimated $71.7 billion on GLP-1 drugs including Ozempic and Wegovy in 2023, a 500 percent increase from their spending on such drugs five years earlier, according to a research letter published in JAMA Network Open... Sub. Req’d

Walgreens to Pay $300 Million in US Opioid Settlement

(4/21, Brendan Pierson and Ismail Shakil, Reuters) ...The money, plus 4% interest annually, will be paid out over six years under the terms of the agreement. Walgreens will also owe the U.S. an additional $50 million if the company is sold, merged, or transferred prior to fiscal year 2032, the Justice Department said. "We strongly disagree with the government's legal theory and admit no liability," Walgreens spokesperson Fraser Engerman said in a statement... Full

Cost Plus Drugs and Oread Rx to Launch OTULFI™, An Affordable STELARA® Biosimilar, In April 2025

(4/21, Oread Rx) ...OTULFI™, is available through Cost Plus Drugs, offering nearly 90% annual savings compared to its reference product, STELARA®. Biosimilars, like OTULFI™, offer patients the same clinical benefit as their reference biologics, providing a safe and effective treatment option at a fraction of the cost... Full

Focus: Trump Looking at Cutting US Drug Prices to International Levels, Sources Say

(4/22, Patrick Wingrove, Reuters) ...Drugmakers have been warned that the Trump Administration is considering linking U.S. medicine prices to lower amounts paid by other developed countries, according to two company sources who called the option the pharmaceutical industry's top concern. Both sources, who were not authorized to speak publicly, said they expected the policy to come from the agency that oversees Medicare and Medicaid health programs...The two sources said any such policy was more concerning to the industry than other government moves under discussion, which include tariffs on imported medicines. The first source said it is the biggest "existential threat to the industry and U.S. biosciences innovation."... Full

Roche to Invest $50 Billion in US to Avoid Trump Tariffs, Create 12,000 Jobs

(4/22, John Revill, Reuters) ...Roche said on Tuesday it would invest $50 billion in the United States over the next five years, creating more than 12,000 new jobs, in the latest massive investment by companies reacting to President Donald Trump's tariff policy...The executive did not mention the threat of looming tariffs, although Roche has analysed potential charges in recent weeks and was "well prepared to navigate them, apply mitigation measures, and adapt," a spokesperson said... Full

Regeneron Inks $3 Billion Fujifilm Deal to Bolster US Drugmaking

(4/22, Madison Muller, Bloomberg Law) ...Fujifilm will produce drugs for Regeneron, maker of the $14 billion a year inflammation treatment Dupixent, at its facility in Holly Springs, North Carolina. The site is slated to begin operations later this year and future expansions are already being planned, Fujifilm said..."Increasing our footprint in the US is important," said Regeneron Chief Executive Officer Leonard Schleifer said in an interview. "Demand for our products is growing rather fast," he said. "We needed more manufacturing." The deal "saves us years," Schleifer said... Sub. Req’d

Why Trump's Pharma Tariffs Are a Political Minefield

(4/22, Joseph Choi and Nathaniel Weixel, The Hill) ...Marta Wosinska, senior fellow at the Brookings Institution who specializes in health care economics, said how much patients feel the impact of the tariffs will depend on whether drug companies can pass the costs on to other players in the system. Drug prices are a political land mine, and companies are loath to raise prices given the anger among lawmakers and the public over medical costs. Trump could also face harsh political backlash if tariffs drive drug prices even higher... Full

NCPA: Supreme Court Case Could Impact Lawsuits Against PBMs

(4/21, Jessica Karins, Inside Health Policy) ...A Supreme Court case brought by diagnostic testing company Labcorp could impact patients' ability to file class action lawsuits across the health care industry, according to the National Community Pharmacists' Association (NCPA), which argued in an amicus brief the case could also harm small businesses' ability to sue pharmacy benefit managers... Sub. Req’d

FDA Staff Cuts Hit Biotech: Impact of Layoffs On Drug Development

(4/21, CNBC) ...Former FDA Commissioner Dr. Scott Gottlieb joins ‘Squawk Box' to discuss the impact of mass layoffs at the FDA, impact on drug development and the delivery of new treatments to patients, and more... Full

Reports Document FDA Review Delays: What Drugmakers Should Know Now

(4/22, John W.M. Claud and Michelle L. Butler, FDA Law Blog) ...Like the WSJ, we believe the impacts of such drastic staff cuts are a near certainty, but we are also cautious not to attribute every delay or unanswered email to the RIF and leadership changes. Some regulatory actions or inactions like the three cited in the WSJ article may not be attributable to anything other than the machinations of a large agency and are of the sort that have plagued clients for years. FDA's failure to respond to a substantive question in two weeks' time is hardly cause for concern, the proximity to the RIFs notwithstanding. Exercising a keen eye to discern which actions or inactions are actually being caused by the recent events may aid us in being more effective at combating them... Full

Californians Can Now Buy Naloxone Directly from the State

(4/21, Sophia Bollag, San Francisco Chronicle) ...California is purchasing the drug from Amneal Pharmaceuticals through its CalRx program, an initiative launched by Newsom to contract with drugmakers to produce cheaper generic alternatives to existing drugs that are no longer protected by patents...Newsom and lawmakers have appropriated $150 million from the state's opioid settlement funds to purchase and distribute naloxone from 2023 through 2027... Sub. Req’d

Utah Contract Pharmacy Law Challenged by Drugmaker Trade Group

(4/21, Ganny Belloni, Bloomberg Law) ...The lawsuit, filed Friday by the Pharmaceutical Research and Manufacturers of America in the US District Court for the District of Utah, alleges that Utah Senate Bill 69 violated the Constitution's Supremacy Clause by requiring drugmakers to offer discounted medications to an unlimited number of contract pharmacies within the state. Under the federal 340B program, drugmakers are required to discount drugs for covered entities, such as qualifying hospitals, clinics, and providers, that treat a disproportionate number of low-income and uninsured patients... Sub. Req’d

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

(4/21, Dave Wallace, Pink Sheet) ...While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe's annual biosimilars conference, regulators from around the world talked about how their thinking is converging... Global Sub. Full

Trump's Tariffs Shake Global Pharma—India at the Crossroads of Crisis and Opportunity

(4/22, Shariq Khan, The Economic Times) ...Industry stakeholders told ET Digital they are concerned by the way Trump is rewriting the global trade norms but see opportunities if India plays its cards right. There is a consensus that Trump's high tariffs on Chinese pharmaceuticals are expected to create a market opportunity that India should seize. The pharma sector has escaped the harshest impacts of Trump's tariffs, says Virinchi Shah, former President of the Indian Drug Manufacturers Association (IDMA). "I think it is because Trump also understands the win-wins of trading with us in the pharma sector," he explains... Full

Korea Urged to Boost Efforts to Stabilize Pharmaceutical Supply Chains

(4/22, Kim Dong-young, AJP) ...South Korea is lagging behind other major nations in implementing systems to address pharmaceutical supply chain instabilities, according to a report by the Korea Institute of Science&Technology Evaluation and Planning (KISTEP)...The report noted that the country has faced persistent medication shortages, with 46 essential drugs either ceasing production or importation over a three-year period. As of April last year, 490 medications were identified as facing supply instabilities, including 95 designated as essential or shortage-prevention drugs... Full

Drug Review Processes to Be Shortened, FDA Says

(4/22, Esme Yeh, Taipei Times) ...New drug review processes would be accelerated and completed in 120 days in response to a US plan to raise pharmaceutical tariffs, the Ministry of Health and Welfare said yesterday. Food and Drug Administration (FDA) Deputy Director-General Wang Der-yuan yesterday told a news conference that measures have been taken to optimize new medicine review processes and help pharmaceutical companies obtain drug permit licenses as soon as possible... Full

Sales of Generics of Ozempic Steadily Growing in Russia

(4/22, The Pharma Letter) ...Russian public procurements of drugs based on the active ingredient semaglutide, which is an original drug from Denmark's Novo Nordisk (NOV: N) and marketed as Ozempic for diabetes and Wegovy for obesity, increased by 28% in 2024 compared to the previous year to 2.3 billion roubles ($28.1 million), according to latest data of the Russian analytical system for tender management Tenderplan, reports The Pharma Letter's local correspondent... Sub. Req’d

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.