Monday, March 10, 2025

Amneal's Rytary Follow-On Crexont Could Hit $500M In Sales

(3/7, Dean Rudge, Generics Bulletin) ...Approved by the US Food and Drug Administration only in August last year, Amneal's Crexont (carbidopa/levodopa) extended-release capsules for Parkinson's disease has "exceeded expectations" in its early months on the market, with market share reaching about 1% in just the back third of 2024 and on track to exit the year at 3%+, according to the US-based player...Under a patent-litigation settlement struck in 2018, Teva will be able to launch its proposed generic version of Rytary beginning in July 2025. To date, no Rytary abbreviated new drug application products have been approved by the FDA... Global Sub. Full

STADA's Growth Journey Continues in 2024

(3/7, The Pharma Letter) ...German generics and consumer healthcare major STADA Arzneimittel (SAZ: Xetra) today released financial results, which the firm said continued its profitable growth journey in 2024 – supported by its strong commercial network in Europe, and complemented by a growing presence in the MENA, Eurasia and Asia-Pacific regions... Sub. Req’d

Celltrion Receives U.S. Approval for Zolair Biosimilar ‘Omlyclo'

(3/10, Kim Min-jee, Korea IT Times) ...Notably, Omlyclo has secured the status of the first Zolair biosimilar approved in the U.S., following approvals in major countries such as Europe (EC), South Korea, the UK, and Canada, establishing its ‘first mover' advantage. This positions Celltrion to gain a competitive edge in the global omalizumab market through strategic market penetration. Additionally, Omlyclo has been recognized in the U.S. as an 'interchangeable' biosimilar, allowing pharmacies to substitute it for the original product without requiring a prescription change from healthcare providers... Full

Biocon Biologics' Biosimilar Yesintek Shows Positive Phase 3 Results for Psoriasis Treatment

(3/7, Jomy Jos Pullokaran, CNBC TV-18) ...Biotechnology firm Biocon Ltd on Friday (March 7) said its subsidiary Biocon Biologics Ltd has announced positive results from its phase 3 clinical trial for Yesintek, a biosimilar to ustekinumab (marketed as Stelara). The randomised, double-blind, parallel-group, multi-centre study evaluated Yesintek in adult patients with moderate to severe chronic plaque psoriasis (PsO). The findings, which confirm the biosimilar's efficacy and safety profile compared to Stelara, are being presented at the 2025 American Academy of Dermatology (AAD) annual meeting in Orlando, Florida... Full

India's Sun Pharma to Acquire Checkpoint Therapeutics for $355 Million

(3/9, Aleef Jahan, Reuters) ...The deal is in line with Sun Pharma's active push in recent years to expand its oncology and immunotherapy portfolio through several acquisitions and collaborations. Last year, it signed a licensing agreement with Italian-Swiss firm Philogen for its anti-cancer drug Fibromun. Monday's transaction, which is expected to be completed in the second quarter of 2025, will add UNLOXCYT, a U.S. FDA-approved treatment for advanced skin cancer, to Sun Pharma's global franchise... Full

Hikma Races to Launch Generic Versions of Blockbuster Obesity Drugs

(3/9, Hannah Kuchler, Financial Times) ...The FTSE 100 group is racing to produce a generic form of semaglutide, the active ingredient in the drugs. Patents on the branded versions are due to expire in Canada, China, India and Brazil in 2026, and in other markets between 2028 and 2032. Riad Mishlawi, Hikma's chief executive, said the impact of the new class of drugs had a comparable impact to the first antibiotic penicillin...Mr Mishlawi said the price of generic liraglutide had plummeted even though there are only two drugmakers selling it – Hikma and Teva – in the US. "I don't think it has hit rock bottom yet, but I think with one or two more players, it will easily get to that level," he said... Full

Why the Obesity Drug Revolution Is a Work in Progress: QuickTake

(3/10, Madison Muller, Robert Langreth and Ike Swetlitz, Bloomberg Law) ...Potential profits have lured a growing number of drugmakers to try to develop their own weight-loss treatments. Meanwhile, front-runners Lilly and Novo are racing to develop treatments that outperform their current blockbusters before their patents run out. However, it's unclear how much drug companies will be able to improve upon Zepbound's efficacy, if at all... Sub. Req’d

Industry Voices—The GLP-1 Status Quo is No Longer Acceptable, But it is Changeable

(3/7, Ashley Holzworth-Nash, Fierce Healthcare) ...Make no mistake: we're facing an inflection point when it comes to GLP-1medications. The GLP-1 market has evolved rapidly over the past decade and a half since the first medication was approved for the treatment of Type 2 diabetes. When GLP-1s were approved for weight-loss, we faced the first major challenge to market stability. Estimates predict that half of the U.S. population will have obesity by 2030, standing as one of the greatest health threats America faces as a nation... Full

Editorial: Cost Analysis of SMART Therapy to Improve Asthma Outcomes

(3/7, American Lung Association) ...National asthma guidelines published in 2020 recommend that most patients with moderate-to-severe asthma would benefit from using one inhaler that includes both a long-term anti-inflammatory medicine and quick-relief medicine. This treatment is called SMART (or MART), which stands for Single Maintenance and Reliever Therapy. Studies show that using a single inhaler reduces the risk of asthma flare-ups by about 30%, compared to using one daily maintenance inhaler plus a separate, quick-relief inhaler as needed. However, only a small number of the 25 million people with asthma in the U.S. are prescribed and use SMART... Full

Start of 2025 Comes with Generic Drug Price Decreases, Several Major Increases, Report Finds

(3/7, Zachary Brennan, Endpoints News) ...More generic drug prices decreased than increased in January, a new report from 46Brooklyn found. The report said for every generic drug price increase in January, 1.3 generic drugs saw their price decrease. It's a trend that 46Brooklyn CEO Antonio Ciaccia called "a largely favorable view." Even still, three generic drugs saw their prices increase significantly, including the nerve pain drug pregabalin ER 165 mg (26% increase), the nausea drug dronabinol 10 mg (21% increase), and the ADHD drug methylphenidate CD 30 mg (18% increase)... Full

Bridging the Gap in Patient Support: How GoodRx is Revolutionizing Access to Specialty Meds

(3/7, Adam J. Fein, Ph.D., Drug Channels) ...The cost of developing a new drug continues to climb, and so has the cost of supporting patients taking it post-launch. Each year pharmaceutical manufacturers invest billions of dollars into patient support programs (PSPs)—sometimes delivered using a hub model—designed to assist patients throughout their treatment journey with education, financial assistance, and adherence support. Industry spending on PSPs was estimated at $5 billion annually in 2021 and has continued to grow steadily. PSPs suffer from chronic lack of awareness and utilization... Full

How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment

(3/9, Skylar Jeremias and Josh Canavan, PharmD, The Center For Biosimilars) ...This episode of Not So Different focuses on the critical issue of cost-related nonadherence in biologic treatments and the role of biosimilars in delivering promised savings. Despite the FDA approving 68 biosimilars, they currently make up only 2% to 3% of the U.S. biologics market, with market share varying significantly between individual markets, ranging from 8% to 82%... Full

One Year Later: Lessons Learned from the Change Healthcare Cyberattack

(3/7, Paige Minemyer, Fierce Healthcare) ...David Bailey, vice president of consulting services at Clearwater, a firm focused on cybersecurity in healthcare, told Fierce in an interview that the incident highlighted challenges in healthcare beyond fending off digital threats, as organizations grappled with a key service taken offline. The Clearwater team fielded questions from groups across the industry, and what became clear is that there are still significant barriers to information that organizations need to prepare themselves for in a cybersecurity event, even one on a smaller scale than the hit on Change, he noted... Full

Pfizer CEO: Trump, Kennedy Sympathetic To ‘Pill Penalty' Concerns

(3/7, Maaisha Osman, Inside Health Policy) ...Pfizer CEO Albert Bourla says both President Donald Trump and HHS Secretary Robert F. Kennedy Jr. have shown sympathy towards the pharmaceutical industry's concerns regarding the Inflation Reduction Act's (IRA) "pill penalty" provision, which pharma lobbyists argue discourages research into small molecule drugs... Sub. Req’d

Senate Dems Push 'Long-Shot' Bill with PBM Reform, Telehealth Extensions and 3.5% Doc Pay Fix

(3/7, Emma Beavins, Noah Tong, Fierce Healthcare) ...Senate Democrats, led by Ron Wyden, Oregon, have revived a bipartisan healthcare package pushed aside at the end of 2024 that includes telehealth extensions, pharmacy benefit manager (PBM) reform, reverses doc pay cuts and addresses the opioid crisis, reveals proposed legislation obtained by Fierce Healthcare...Though many of its provisions are widely supported on both sides of the aisle and are regarded as top priorities for lawmakers, one lobbyist told Fierce Healthcare the package has a "long shot" of passing. Republicans may want to save some of the cost offsets for budget reconciliation, they said... Full

I'm a Healthcare CEO Who Has Fought Medication Middlemen. Then my Daughter's Condition Made it Personal.

(3/8, Kathy Oubre, FOX News) ...Congress must take immediate action to pass meaningful PBM reform. The House Energy and Commerce's Subcommittee on Health recently held a hearing to discuss PBM-driven price inflation, barriers to care, and market consolidation. The testimony reinforced what patients and healthcare professionals already know: PBMs are driving up costs and limiting access, not lowering them. These reforms have broad bipartisan support and represent real solutions. Patients deserve more than vague commitments; they deserve action... Full

Garbarino, Suozzi, Harshbarger Introduce Ensuring Access to Essential Drugs Act

(3/7, United States Congressman Andrew Garbarino) ...[Chirag Patel and Chintu Patel, Co-CEOs of Amneal Pharmaceuticals] "At Amneal Pharmaceuticals, we believe that no patient should ever have to worry about access to the life-saving medicines they depend on. This bipartisan legislation is a vital technical fix that will safeguard access for the 19 million American patients who rely on levothyroxine. It will also help ensure a reliable, high-quality domestic supply for what is one of the most commonly prescribed chronic disease therapies for Americans. Regulatory technicalities should never stand in the way of patient care..."... Full

AAM Commends Q1/Q2 House Bill Reintroduction

(3/7, AAM) ...The Association for Accessible Medicines today applauded the reintroduction of Q1/Q2 legislation in the U.S. House of Representatives by Congressmen Dunn of Florida and Mullin of California. The legislation reintroduces bipartisan and bicameral language that was included in the 2024 year-end spending bill that was initially introduced... Full

Makary Signals Some Interest In US FDA Staff Cuts, Fighting Patent Thickets

(3/7, Sarah Karlin-Smith, Pink Sheet) ...FDA Commissioner nominee Martin Makary said during his Senate confirmation hearing that he planned to assess agency personnel and did not seem opposed to some reductions. Makary also was interested in tackling patent thickets that prevent cheaper biosimilar and generic drugs. Makary seemed supportive of clinical trial diversity, but was unaware of Trump Administration actions in the area... Global Sub. Full

Experts Propose Restricting Trademarks On Accelerated Approval Drugs to Speed Confirmatory Trials

(3/7, Jeff Craven, Regulatory Focus) ...Manufacturers might be incentivized to speed up completion of confirmatory trials for their accelerated approval drugs if they are restricted from using a brand name until the drug is granted full regulatory approval by the US Food and Drug Administration (FDA), according to a recent Viewpoint article published in JAMA Health Forum... Full

FDA's Accelerated Approval Guidance Gets Pushback from Industry

(3/7, Joanne S. Eglovitch, Regulatory Focus) ...The pharmaceutical industry has some questions regarding the US Food and Drug Administration's (FDA) recent guidance on its accelerated approval program for drugs and biologics. Industry groups also asked for greater clarity about when the agency will provide feedback on confirmatory trials and how the guidance would align with the agency's other policies on accelerated approval... Full

Generic Approvals Maintained Pace In December And January, But Is A Slow-Down Coming?

(3/7, Derrick Gingery, Pink Sheet) ...Data indicate that full and temporary ANDA approvals were much higher in December than the average over previous months. After seemingly maintaining the pace in January, approvals and temporary approvals appear to have slowed in February. December 2024 data show that submissions increased after two very slow months, but the total was less than the same month in prior years... Global Sub. Full

The Failed Experiment of State Drug Affordability Boards

(3/7, Michael W. Hodin, Peter J. Pitts, DC Journal) ...State legislatures want to chalk up the passage of prescription drug affordability boards (PDABs) as a victory for patients and a political win to address the cry of high drug prices. However, years after many of these boards were established, we're getting a clearer picture of what these boards are failing to accomplish... Full

Medicines for Europe Supports Legal Action Against Provisions in the Urban Wastewater Treatment Directive (UWWTD), Which Puts Access to Medicines at Risk

(3/10, Medicines for Europe) ...Medicines for Europe supports its members Accord, Adamed, Fresenius Kabi, Insud, Polpharma, Sandoz, STADA, Teva, Viatris and Zentiva who have filed a legal case with the Court of Justice of the European Union against the creation of an Extended Producer Responsibility (EPR) system in the Urban Wastewater Treatment Directive (UWWTD). The legal action seeks to avoid a discriminatory and disproportionate cost burden and thus to safeguard patient access to vital medicines... Full

EU Critical Medicines Act Unveiling On March 11,–Industry Backs, But Urges Caution

(3/7, Neena Brizmohun, Pink Sheet) ...The new act aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU. It should recognize differences between generics and innovative products, says industry group EUCOPE... Global Sub. Full

US Tariffs Present Dual Threat for EU Economy, Health Economists Warn On Pharma Impact

(3/7, Vasiliki Angouridi, Euractiv) ...While tariffs on cars and semiconductors are largely expected, given the recent trade policies of the US administration, as Kostas Athanassakis, assistant professor of Health Economics at the University of West Attica, told Euractiv: "For [pharmaceuticals], it feels highly extraordinary; [because they], widely acknowledged as "merit goods" have historically been excluded from trade wars due to their unquestionable impact on collective welfare."... Full

Europe Should Diversify Drug Supplies to Face Health Crises, Ministers Say

(3/9, Andreas Rinke, Reuters) ...Price pressure on cheap generics along with higher labour and environmental costs, has driven medicine production away from Europe, leaving it exposed, it said, urging the EU Commission to include the CMA in a broader security framework. The ministers said that could be done along the lines of the U.S., where pharmaceuticals are considered part of defence goods supply chains, and proposed ramping up domestic production and centralised stockpiling, when possible. "Several medicines, including antibiotics, anaesthetics, and thrombolytics, are not only vital for civilian healthcare but also for military and emergency scenarios," they said... Full

Pharma Exporters Eye ‘Preferential Treatment' by US

(3/7, Manu Kaushik, Financial Express) ...Viranchi Shah, national president at Indian Drugs Manufacturers Association (IDMA) said that while India accounts for just 5.6% of the US' total pharma imports of $160 billion annually, the country supplies he largest amount of low-cost generics to the US market... Full

New Drug Export Rule a Bitter Pill for Sector: Pharma Body

(3/10, Teena Thacker, Economic Times) ...Pharmexcil urges a review of a new rule for drug exports in India, which requires a product registration certificate from the importing country or Indian regulator approval. This could strain India's pharmaceutical export sector and potentially lead to illegal dealings. The new rule's complexity and challenges could burden exporters, stifle innovation, and inadvertently harm India's pharma industry... Full

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