Tuesday, April 8, 2025

Fremanezumab Aims to Become First CGRP-Targeting Migraine Preventive for Pediatric and Adults Following sBLA Acceptance

(4/7, Neurology Live) ..."Migraine is common among children and adolescents, often disrupting their education, social lives and overall well-being, yet treatment options remain limited," Eric Hughes, MD, PhD, executive vice president, global R&D, and chief medical officer at Teva, said in a statement.1 "As we work to bring the benefits of Ajovy to younger patients, we build upon its proven success in adults. If approved, Ajovy could be an important step toward filling the gap in pediatric migraine care, offering a much-needed solution for this underserved population."... Full

Fremanezumab Under Review for Pediatric Episodic Migraine Prevention

(4/7, Diana Ernst, Rph, Medical Professional Reference) ...Findings showed that compared with placebo, treatment with fremanezumab led to a significantly greater reduction in monthly migraine days (primary endpoint; -2.5 vs -1.4; P =.0210) and monthly headache days (secondary endpoint; -2.6 vs -1.5; P =.0172) over the 12-week treatment period. Additionally, more patients in the fremanezumab group achieved at least a 50% reduction in monthly migraine days compared with those in the placebo group (47.2% vs 27%; P =.0016)... Full

Samsung Rolls Out Second US Soliris Biosimilar – At 30% WAC Discount

(4/7, Dean Rudge, Generics Bulletin) ..."Individuals living with rare diseases, including paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis, often have limited access to life-enhancing medicines," noted Thomas Rainey, Teva's senior vice president for US biosimilars. "We are proud to launch Epysqli in the US as a new, more affordable treatment option to help expand access to these underserved communities, further expanding our biosimilars medicine portfolio and efforts to deliver important medicines to patients through strategic partnerships that leverage our proven commercialization abilities."... Global Sub. Full

Teva, Samsung Bioepis Launch Soliris Biosimilar

(4/7, Sandra Levy, Drug Store News) ...Teva and Samsung Bioepis are offering Epysqli, which is is a biosimilar to Alexion Pharmaceuticals' Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive... Full

Samsung Bioepis Launches Soliris Biosimilar in US Through Teva

(4/8, Lee Han-Soo, Korea Biomedical Review) ...Soliris recorded global sales of approximately $2.58 billion last year, of which U.S. sales accounted for around $1.52 billion. Known as one of the most expensive biologics on the market, a year-long treatment of Soliris for PNH patients costs an estimated $520,000. Samsung Bioepis said Epysqli has entered the U.S. market at a wholesale acquisition cost (WAC) that is 30 percent lower than the originator drug... Full

Teva and Samsung Bioepis Launch EPYSQLI in the U.S.

(4/7, Rachel Klemovitch, Contract Pharma) ...The FDA has provisionally determined that EPYSQLI will be interchangeable with the reference biologic Soliris, following the expiration of exclusivity for the first interchangeable biosimilar. EPYSQLI is a paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and an atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy... Full

Viatris Agrees to Pay up to $335M to Settle Opioid Claims

(4/7, Kevin Dunleavy, Fierce Pharma) ...Viatris has agreed to a settlement in which it will pay up to $335 million to resolve opioid-related claims to state and local governments, the Pittsburgh-based generics specialist said on Monday. Viatris will pay between $27.5 million and $40 million annually over the next nine years. The funding will help support government efforts to address opioid-related issues, the company added... Full

Amneal Announces New Data from Phase 3 Study Showing Significant Improvements in Sleep Quality with CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules in Parkinson's Disease

(4/7, Amneal Press Release) ..."It's exciting to see the expanding body of research supporting CREXONT and its positive impact on patients. As we continue to explore the full benefits of CREXONT, we are optimistic that increased ‘On' time throughout the day with fewer doses – and as now demonstrated, enhanced sleep quality – can help improve overall quality of life for more PD patients," said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty at Amneal Pharmaceuticals... Full

Celltrion's Stelara Biosimilar Secures Formulary Listing with Major US PBM

(4/8, Lee Han-Soo, Korea Biomedical Review) ....Celltrion's Steqeyma (ingredient: ustekinumab), its Stelara biosimilar, has secured early access to a reimbursable market in the U.S. after being added to the formulary of a major U.S. pharmacy benefit manager (PBM) last Thursday, just one month after its market debut. However, the company did not disclose the name of the PBM, citing contractual confidentiality. The PBM in question is estimated to account for approximately 22 percent of the U.S. insurance market... Full

Celltrion Unveils Strategy Amid Series Of Milestones

(4/7, Adam Zamecnik, Generics Bulletin) ...In addition to its ambitions within its pipeline, Celltrion has also set mid-to-long-term targets for revenue and profitability. By 2027, the company wants to exceed a 30% compound annual growth rate. At the same time, Celltrion is targeting north of 7% as its ROE, having previously reported a 2.4% ROE in 2024. Nevertheless, while the company may be aiming to boost its portfolio of novel products, the past weeks have seen multiple updates to Celltrion's biosimilars catalogue... Global Sub. Full

Wockhardt to Exit Residual US Generics Business for "Commercial Reasons"

(4/7, The Hindu Business Line) ..."We have decided to exit the business because of commercial reasons. ... And it has nothing to do with tariffs announced," Wockhardt Chairman Dr Habil Khorakiwala told businessline, against the backdrop of US President Trump's announcement that pharmaceuticals would see unprecedented tariffs. The company had third-party alliances in the US, and so was not expected to be hurt by the import tariffs. "Overall it is not a worthwhile proposition for us to continue," he said... Full

Khorakiwala did not give a timelineHow Markets Solved the GLP-1 Shortage

(4/8, Tony Losasso, The Wall Street Journal) ...The lesson is clear: Opening healthcare to free-market forces leaves consumers better off. Of course, simply pulling patents isn't the way to accomplish this -- FDA shortage declarations are temporary for a reason. Drug development is far too risky to draw the requisite investment without exclusive rights. Absent patents, there would be far less innovation and far fewer new therapies... Sub. Req’d

CVS, Express Scripts, Optum Warm up to Biosimilars

(4/8, Lauren Berryman, Modern Healthcare) ...A decade since the first biosimilar medicine reached the U.S. market, pharmacy benefit managers are getting serious about these lower-cost versions of biologic drugs. CVS Caremark, OptumRx, Express Scripts and other PBMs remained loyal to big-ticket brand-name pharmaceuticals such as Humira, in part because they enjoyed lucrative rebates from drugmakers. Now, leading PBMs are giving preference to biosimilars over branded biologics on their formularies and promising significant savings to health insurers and plan sponsors such as employers... Full

For Opioid Victims, Payouts Fall Short While Governments Reap Millions

(4/8, Aneri Pattani, KFF Health News) ...That discrepancy between individuals' and governments' compensations highlights a sense of injustice felt by people directly affected by the crisis who say their suffering is the reason that governments secured these settlements. Opioid settlements with companies like Purdue Pharma, Walmart, and Johnson & Johnson have led to headline-grabbing multibillion-dollar payouts, but most of the windfall is flowing to state and local governments, not directly to victims of the crisis... Full

Trump's Tariff Threat Sparks Race to Find US Drug Manufacturers

(4/7, Gerry Smith, Madison Muller, and Ike Swetlitz, Bloomberg) ...Drug manufacturers are rushing to reshape their supply chains amid President Donald Trump's escalating tariff threats, leading to a potential windfall for contractors that make medications in the US. Those lesser-known firms, such as Lonza Group AG, Thermo Fisher Scientific Inc. and Catalent Inc., help big pharma companies with their complex supply chains, from filling syringes and producing pills all the way to manufacturing complicated biologic drugs from scratch... Sub. Req’d

Drug Tool and Packaging Makers to Feel Brunt of Trump Tariffs, Analysts Say

(4/7, Anna Brown, Endpoints News) ...According to analysts from RBC Capital Markets, companies that make pharma tools — like syringes, autoinjectors and other similar equipment — are included in Trump's 10% global levy, on top of additional country-specific tariffs such as a 20% tax on European products and 34% on China. The tariffs will impact businesses either through tariffs on drug tools and packaging going to the US, or through importing raw materials to the US to make these products domestically. As such, pharma companies and CDMOs could feel pricing impacts downstream as these suppliers raise prices, RBC analysts said... Sub. Req’d

Trump's Tariffs: Coming To Your Medicine Cabinet Soon

(4/8, Alex Knapp, Forbes) ...When they do, one of the biggest losers would likely be generic drug manufacturers and, since they account for about 90% of all prescriptions in the United States, a huge segment of Americans who rely on them. About 47% of all generics prescribed in the U.S. are made in India, which is currently facing a 26% tariff. Some, like common heart medications, cost less than a dollar a pill — a price that if tariffed might cause their manufacturers to reconsider the value proposition of making them... Full

CMS Scraps Pharmacy Notification Requirement In Final Part D Rule

(4/7, Gabrielle Wanneh, Inside Health Policy) ...The Trump administration will not require insurers or pharmacy benefit managers to notify pharmacies of their status in a pharmacy network prior to the beginning of open enrollment for a given plan year, nor will the agency allow pharmacies to walk away from plan contracts or network participation without providing justification, as these previously proposed policies were left out of the final contract year 2026 Part D rule released Friday (April 4)... Sub. Req’d

The Possible Demise of User Fees: Existential Threats Require Outside-the-Box Thinking

(4/7, Steven Grossman, FDA Matters) ...There is an urgent need to counter the widespread assumption that user fees will be renewed because the alternatives are unthinkable. True, Congress is not going to provide the extra $2.6 billion in taxpayer funding. But we now have leaders who seem ready, perhaps eager, to let the user fee programs lapse. The existential threat is real. Fresh, outside-the-box thinking is essential if we are to prevent a potential disaster... Full

FDA Cuts Threaten Medical Product Review Programs

(4/8, Tina Reed, Axios) ..."It would be catastrophic," said one former official of the possibility, noting that 83% of the payroll for the FDA's Center for Drug Evaluation and Research (CDER) is covered by user fees..."If they go away, 83% of CDER would have to be furloughed, which means that the center is gone."... Full

Sources: Layoffs Could Impact FDA's Inspection Capacity

(4/7, Joanne S. Eglovitch, Regulatory Focus) ...The CBS report cites unnamed senior officials at FDA who said that approximately 170 support staff from OII were laid off last week, prompting the agency to consider reducing the number of routine surveillance inspections in order to preserve capacity for higher priority inspections in response to safety issues and follow-up visits to troubled facilities... Full

'A Slow-Moving Catastrophe': FDA Cuts Are like Firing All Hospital Staff Except Doctors, Janet Woodcock Says

(4/7, Gabrielle Masson, Fierce Biotech) ..."I don't know what the administration's rationale for all these cuts were," said Woodcock, who spent more than 38 years at the FDA. "For example, CBER was about 70% funded by user fees," she explained. "Therefore, if you ran a pro rata calculation, you'd only be cutting out of the 30% that was paid for by taxpayers a month." Woodstock also said the claim that the cuts made won't impact drug reviews is a "naive conception."... Full

US FDA Center Directors Are Political Now

(4/7, Michael McCaughan, Pink Sheet) ...The forced resignation of Peter Marks, the director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, is the latest in a series of disruptive actions raising red flags about the near-term outlook for drug and biologic approvals. But the move also is precedent-setting and likely to establish a new norm for the FDA for decades to come. Center director positions now will be treated as political appointees that change with each new presidential administration... Global Sub. Full

Prescription Drug Board's Payment Caps Expanded in Maryland

(4/7, Celine Castronuovo, Bloomberg Law) ...The bill (HB 424) builds on the 2019 law setting up the Maryland Prescription Drug Affordability Board by expanding the caps for state-run health plans to also apply to any health payer in the state. The legislation, if signed by Gov. Wes Moore (D), will take effect Oct. 1, 2025, and would have Maryland join Colorado, Minnesota, and Washington with the ability to control what any health plan pays in the state for some of the most expensive drugs... Sub. Req’d

Lilly Insulin Probe Gets More Michigan Supreme Court Arguments

(4/7, Eric Heisig, Bloomberg Law) ...The justices, whose arguments last October were on whether to accept the case, said April 4 that they were interested in several topics. They include whether Attorney General Dana Nessel (D) sufficiently alleged in a lawsuit that Lilly violated the Michigan Consumer Protection Act and whether that's necessary to determine whether an exception to the law applies... Sub. Req’d

Trump Has Australia's Generic Medicines in His Sights. And No-One's Talking about it

(4/7, The Conversation) ...Buried on page 19 of the Trump's administration's allegations of barriers to trade was a single paragraph related to Australia's access to generic medicines. These are cheaper alternatives to branded medicines that are no longer under patent. The US is concerned about how much notice their drug companies have that Australia will introduce a generic version of their product... Full

Medicines For Europe Sets Out Vision For Biosimilars Reforms

(4/8, Dave Wallace, Generics Bulletin) ..."Europe has historically led the way in biosimilar adoption and policy development," the industry association highlighted, "enabling biological medicine affordability and access for millions of European patients." But it said a "fit for the future biosimilar medicine policy should target broader, transformative opportunities for innovation in healthcare delivery, patient outcomes and technological progress."... Global Sub. Full

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