Friday, March 28, 2025

Kabi Lines Up Denosumab Biosimilar Launch As FDA Says Yes To Filings

(3/27, Dean Rudge, Generics Bulletin) ...Denosumab has seen a flurry of activity in March, as only days before Kabi's FDA approval, Alvotech's AVT03 proposed biosimilar to Prolia/Xgeva was successfully filed by its partner Dr Reddy's Laboratories...And Teva also filed a denosumab candidate with the FDA last year, marking the Israeli firm's first internally developed biosimilar to be submitted to the FDA, outside of its so far partnered model... Global Sub. Full

Henlius Builds Profitability Streak With Second Year In The Black

(3/27, Adam Zamecnik, Generics Bulletin) ...According to Henlius, the growing commercial sales of its core portfolio was instrumental in this rise in profitability. For the past fiscal year, the company sold RMB4.9bn's worth of core products, which represents an 8.3% year-over-year increase. This includes the company's biosimilars and its innovative molecule...Nevertheless, the bulk of the sum was made in Henlius' domestic market, with RMB117.6m in overseas sales revenue. Still, the reported overseas figure grew by 27% year-over-year... Global Sub. Full

Dr Reddy's Bags Rights To Two More Biosimilars In Deal With Bio-Thera

(3/27, Dave Wallace, Generics Bulletin) ...While Stelara has seen competition from numerous biosimilars developers across the world – with rivals having already launched in major markets including Europe and the US, leading to fierce discounting – Simponi is relatively unchallenged. Only one other developer, Alvotech, has disclosed that it is pursuing a golimumab biosimilar, and claimed a worldwide first with a recent filing of its AVT05 candidate with the European Medicines Agency, ahead of a filing with the US Food and Drug Administration shortly afterwards... Global Sub. Full

Dupixent® (Dupilumab) Approved as the First-Ever Biologic Medicine in Japan for Patients with Chronic Obstructive Pulmonary Disease (COPD)

(3/288, Regeneron Pharmaceuticals) ...In addition to COPD, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and chronic spontaneous urticaria (CSU). Dupixent for the treatment of COPD has been approved in more than 45 countries worldwide, including the 27 member countries of the European Union (EU)... Full

Rare Metabolic Disease That Leads to Childhood Obesity Gets Its First FDA-Approved Drug

(3/27, Frank Vinluan, MedCity News) ...Vykat's main pharmaceutical ingredient is diazoxide choline...This now generic medicine, marketed by Teva Pharmaceutical as Proglycem, is an oral suspension taken three times daily. Soleno's drug is formulated into an extended-release tablet that leads to lower peak concentrations in the blood compared to Proglycem...Based on an analysis of medical claims data, Soleno calculates there are about 12,000 Prader-Willi patients in the U.S. An estimated 10,000 of these patients are eligible for Vykat based on the product's label. Though diazoxide is already available via Teva's Proglycem, the Vykat label warns against substituting the lower-cost generic medication for the new Soleno product... Full

Exclusive: Metsera CEO On What it Takes to Build an Obesity Biotech in 2025

(3/27, Kyle LaHucik, Endpoints News) ...Endpoints News caught up with Metsera CEO Whit Bernard, who's been running the 81-person startup since September...The obesity field is "a mega category," said Bernard, "and we're going to need a lot, if not all, of the leaders in the industry participating to really shape that opportunity fully."...Metsera also wants to develop a drug with similar efficacy to the GLP-1s but at lower doses and potentially with oral peptides rather than small molecules... Full

EU Regulator Rejects Eli Lilly's Alzheimer's Drug

(3/28, Mariam Sunny, Padmanabhan Ananthan and Maggie Fick, Reuters) ...The European Union's drugs regulator on Friday rejected Eli Lilly's Alzheimer's drug, saying the risk of serious brain swelling did not outweigh the treatment's small impact on slowing cognitive decline. The rejection of the drug, Kisunla, means Eisai and Biogen's Leqembi will likely pull ahead in the race to become the EU's first approved Alzheimer's treatment, if the European Commission accepts the agency's recommendation on the rival drug... Full

Trump Must Be ‘Harsh' With Big Pharma, Says Icelandic Drugmaker

(3/27, Sonja Wind and Ragnhildur Sigurdardottir, Bloomberg) ...If the US wants to see lower drug prices, it should make it easier for cheaper copies of expensive biologic drugs to enter the market, Alvotech SA Chief Executive Officer Robert Wessman said. Enabling more competition from companies producing such biosimilar copies of older medicines would save a significant amount of money, the founder of the Iceland-based biosimilar maker said in an interview..."Big pharma has all the cards," said Wessman, calling on the US government to be "harsh" on big drugmakers that block generic competition once patents have expired. "This is costing the US patients, taxpayers and everyone else, a lot of billions which could be avoided and saved."... Sub. Req’d

Exclusive: Trump Tariff Threats Prompt Some Drugmakers to Expedite Shipments to US

(3/27, Michael Erman, Maggie Fick, Lisa Baertlein, Reuters) ...Two European-headquartered drugmakers told Reuters this week they are sending as much of their medicines across the Atlantic as possible over the past several weeks and heard other pharmaceuticals companies were doing the same. One of the executives said his company was "scenario planning" for possible tariffs and shipping more medicines by air using global cargo and transport firms including the United Parcel Service Inc and Germany's DHL... Full

With Tariffs On the Way, Generic Drugmaking Woes Could Hinder Trump's Reshoring Plan 

(3/27, Anna Brown, Endpoints News) ..."We just can't shut the door on imports until we have a chance to get the industry to the point where they can take on that extra manufacturing capacity," Kevin Webb, chief operating office of the API Innovation Center (APIIC), said in an interview with Endpoints News..."Generics operate on razor-thin margins," Glenn Hunzinger, US Pharma & Life Science Leader at PwC told Endpoints. "The reality of generics is that the winner tends to be the person who is the lowest-cost provider." Once pharma tariffs are in place, and if generic drugmakers' profits become so low, it'll be difficult for them to reinvest, he added... Full

Will Pharmaceutical Tariffs Achieve Their Goals?

(3/27, Marta Wosinska, Brookings) ...The analysis of the four questions suggests that prices will rise across drugs if tariffs are extended to India and Europe, but the rise will not be for the full amount of the tariffs. The tariff pressure and political considerations will lead to many onshoring announcements for branded drugs. But we should not expect to see the same for generic drug makers because the return on investment for such major capital investments will be too low and uncertain... Full

PBMs Are Breaking Down Barriers to Expand Access to Biosimilars and Lower Consumer Costs

(3/27, PCMA) ...As policymakers tackle America's prescription drug affordability challenge, it's important to remember that Big Pharma sets the price of the prescription drugs - and the price is the number one problem when it comes to Americans facing difficulty affording their prescription drugs. Drug companies raise drug prices year in and year out, often in January and again in July; increases averaged 5.4% in Q1 2024... Full

Wyden Claims Pfizer Used a ‘Colossal' Scheme to Avoid Paying Billions in U.S. Taxes

(3/27, Ed Silverman, STAT+) ...In what one U.S. lawmaker described as possibly the "largest tax-dodging scheme" by a pharmaceutical company in history, Pfizer sold $20 billion in medicines to U.S. customers six years ago, but did not report any profits from those sales on its 2019 tax returns because all of the income was supposedly earned offshore, according to an investigation by the Democratic staff of the Senate Finance Committee... Sub. Req’d

FDA Cuts Could Stall Biotech Deals, Shake Investor Confidence, Experts Warn

(3/27, Maaisha Osman, Inside Health Policy) ...HHS announced Thursday (March 27) plans to cut an additional 3,500 full-time FDA employees, a move that industry experts are already warning could disrupt the biotech sector by delaying critical approvals, inspections and policy decisions--and in turn potentially slowing mergers, acquisitions and investment... Sub. Req’d

US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

(3/27, Derrick Gingery, Pink Sheet) ...Uncertainty about FDA staffing could be slowing preparations for the upcoming prescription drug, generic drug and biosimilar user fee reauthorization negotiations. Any delays could mean less negotiating time and a slimmer package of program reforms in the commitment letter. Industry negotiators are proceeding as if traditional timelines remain in place... Global Sub. Full

FDA's Policy, Communications Staff Likely to Be Among Agency's 3,500 Staff Cuts

(3/27, Zachary Brennan, Endpoints News) ...The House Energy and Commerce Committee is set to hold a hearing next week on user fees for over-the-counter drugs. Democratic Reps. Frank Pallone (NJ) and Diana DeGette (CO) called on committee Chair Brett Guthrie (R-KY) to "hold a hearing on these cuts immediately. There is zero sense in having a routine hearing on user fees next week before understanding the Trump administration's plan to gut the FDA by cutting 3,500 public servants."... Full

Power Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department

(3/28, Sarah Karlin-Smith, Pink Sheet) ...HHS does not have staff with the technical knowledge and skill set to write the kinds of policies pharmaceutical companies and other industries regulated by the FDA need to develop products, a former senior agency official said. The source also said many of the centralization moves were tried in the past by HHS Secretary Tommy Thompson during the George W. Bush administration and reversed due to perceived failure... Global Sub. Full

Virginia Governor Vetos PDAB Legislation A Second Time

(3/27, Luke Zarzecki, Inside Health Policy) ...In a statement from economic policy organization Freedom Virginia, a sponsor of the bill, Delegate Karrie Delaney (D) said Youngkin took the side of pharmaceutical companies. "This bill would have taken crucial steps toward lowering the cost of medicine. Instead, Governor Youngkin caved to Big Pharma's special interests, which will continue to inflate the price of prescription drugs for Virginians," she said... Sub. Req’d

Oregon Won't Set Price Caps On Prescription Drugs — for Now

(3/27, Jake Thomas, The Lund Report) ...State Sen. Deb Patterson, a Salem Democrat who chairs the Senate Health Care Committee, told The Lund Report she has dropped plans to introduce a bill this session that would let an appointed board cap how much government and private insurance pay for certain prescription drugs... Full

Industry Officials: Varied Global Postapproval Change Requirement Pose Challenges for Drugmakers

(3/27, Joanne S. Eglovitch, Regulatory Focus) ...Multiple country-specific requirements for postapproval changes are affecting drugmakers' ability to implement changes in manufacturing facilities or processes. This situation leads to unpredictable timelines and potential delays in providing access to improved medicines. This was highlighted by two industry representatives during a session at DIA Europe 2025 on March 19... Full

Tariff Treatment: Six Diagnoses for EU Pharma Sector Amid US Trade War

(3/28, Gerardo Fortuna, Euronews) ...If the US imposes tariffs on European pharmaceuticals, the EU may respond with countermeasures targeting American pharma companies. The European Commission is reportedly considering options in its "well calibrated and timely response", and this could include higher export costs for major US firms such as Pfizer, Merck, and Johnson & Johnson. Retaliatory measures could affect US drugs like MSD's cancer treatment Keytruda and Eli Lilly's injectable diabetes medicine Trulicity... Full

Trump Threatens the Fighting Irish with Targeted Pharma Tariffs. Game On?

(3/27, Brian Maguire, Euractiv) ...Irish Taoiseach (Prime Minister) Micheál Martin voiced government concerns about the potential tariffs' impact. Speaking in Paris at a summit on Ukraine, Martin stated, "We believe tariffs will damage broader economies across the world, will damage the American companies who are located in Ireland, not just here but in America as well, because these are complicated supply chains between Ireland, Europe and the US in the pharmaceutical area." He urged the EU and the US to engage in discussions for a sensible resolution... Full

Ireland's Health Minister Wants Faster Action On Nicotine Directive, and EU Pharma Package

(3/28, Brian Maguirae, Euractiv) ...Attending this week's informal meeting of EU Health Ministers in Warsaw, Ireland's Minister for Health, Jennifer Carroll MacNeill, sought to prioritise pharmaceutical security and the mental health of young people...A spokesperson for MacNeill said Ireland is working closely with EU member states in negotiations to progress the European Union (EU) pharmaceutical package and hopes that an agreement can be reached on what Ireland views as an important legislative file. They told Euractiv an early agreement would give certainty and stability in the regulatory landscape across Europe... Full

European Urban Waste Water Treatment Directive Set to Significantly Impact Supply of Generic Medicines in Ireland

(3/27, Medicines for Ireland) ...Generic medicines are the mainstay of most patients medicine cabinets, they generally are the lowest cost medications, representing nearly 60 per cent of all prescriptions in 2023. As such, it's anticipated that generic medicine suppliers may be expected to shoulder the bulk of the financial cost under the EPR scheme for removing micropollutants from urban wastewater. This fails to recognise the extremely tight margins given the pricing models for generic medicines... Full

German Ordinance To Implement HTA Reg Leaves Room For Doubt

(3/27, Francesca Bruce, Pink Sheet) ...Germany has published an ordinance to implement the EU Health Technology Assessment Regulation into the German benefit assessment process. The pharmaceutical industry is calling for rules on how joint clinical assessment reports are considered in the national benefit assessment process to guarantee consistency... Global Sub. Full

GSK Wants UK to Open Up Health Records to Boost Drug Development

(3/28, Ashleigh Furlong, Bloomberg) ...GSK Plc is pushing the UK government to give pharmaceutical companies more access to its public health data troves, to accelerate drug development and halt the nation's slide down global life science rankings. The British drugmaker wants the government to invest in more effectively linking clinical, genomic and primary care datasets together and to make them available to researchers and companies... Sub. Req’d

Indian Pharma Could Gain Market Share Amid US Tariffs, Says JPMorgan

(3/28, Ann Jacob, NDTV Profit) ...Tariffs of 25% or higher on pharmaceuticals are improbable due to the significant increase in cost for consumers and the limited availability of alternative suppliers, JPMorgan said...In addition to India, import tariffs on generic drugs from Israel and Switzerland are highly probable, according to the JPMorgan expert. This is due to significant manufacturing presence of Teva and Sandoz in these countries. According to the expert, these companies operate with lower profit margins compared to Indian firms and would therefore be more negatively affected by potential tariffs... Full

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