Tuesday, December 23, 2025

Novo Nordisk wins FDA Approval for Wegovy in a Pill, Introducing First Oral GLP-1 Option for Obesity

(12/22, Fraiser Kansteiner, Fierce Pharma) ...After ushering in a new era of obesity treatment with its GLP-1 medicine Wegovy earlier in the decade, Novo Nordisk is making history again with the first FDA approval of a GLP-1 pill for weight loss. On Monday, the FDA gave a thumbs-up to Novo's oral formulation of Wegovy (semaglutide) as a once-daily pill for weight management and cardiovascular risk reduction in people with obesity or who are overweight. The drug can be given at a maintenance dose of up to 25 mg... Full

FDA Approves Amneal's Two Denosumab Biosimilars for US Market

(12/22, Investing.com) ...Amneal Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has approved its Biologics Licensing Applications for two denosumab biosimilars: Boncresa, referencing Prolia, and Oziltus, referencing XGEVA. The approvals come through Amneal's partnership with mAbxience, a Fresenius Kabi majority-owned group. Under the agreement, mAbxience handles development and manufacturing while Amneal holds exclusive U.S. commercialization rights. Denosumab is a monoclonal antibody that inhibits bone resorption and is used to treat various oncology and osteoporosis-related conditions... Full

Samsung Biologics Acquires Human Genome Sciences from GSK

(12/22, Charlie Sternberg, Contract Pharma) ...Samsung Biologics America, a subsidiary of Samsing Biologics, a CDMO, has entered into a definitive agreement to acquire 100% of Human Genome Sciences from GSK for $280 million. This strategic move secures Samsung Biologics' first U.S.-based manufacturing site. Located in Rockville, Maryland, the facility encompasses two cGMP manufacturing plants with a combined 60,000 liters of drug substance capacity, supporting both clinical and commercial production from small to large scale... Full

FDA Approves Exdensur for Severe Asthma

(12/22, Lori Solomon, Medical Xpress) ...The U.S. Food and Drug Administration has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Exdensur is the first and only long-acting biologic with an extended half-life enabling twice-yearly dosing for patients with severe asthma with an eosinophilic phenotype... Full

Novo Holdings-Backed Windward Buys Rights to Qyuns' Clinical-Stage Immunology Bispecific in $700M Deal

(12/22, James Waldron, Fierce Biotech) ...Having kicked off the year with a $200 million series A, Windward Bio is ending 2025 splashing out on another clinical-stage drug. The deal, announced yesterday, sees Switzerland-based Windward secure the ex-China rights to Qyuns Therapeutics' WIN027, also known as QX027N. The IgG1 bispecific monoclonal antibody targets both human thymic stromal lymphopoietin (TSLP) and human interleukin-13 (IL-13), which Windward noted are "well-validated targets in immunological conditions."... Full

Trade & Channel Strategies 2025: Why Wholesalers Remain Pharma's Backbone

(12/23, Nicholas Saraceno, Pharmaceutical Commerce) ...Ultimately, his message was one of strategic focus and measured response: pharmaceutical manufacturers should resist reacting broadly to tariff headlines and instead evaluate risk, sourcing decisions, and mitigation strategies at the individual product level—where the real impact, if and when it comes, will be felt most acutely. He also commented on how these pharma supply chain lessons can be applied in the future; why he believes wholesalers will remain indispensable despite pharma's push into direct-to-patient sales; and much more... Full

Samsung Bioepis Wins Approval to Sell Autoimmune Biosimilar in Japan

(12/23, Korea JoongAng Daily) ...Samsung Bioepis, a biosimilar drug developer under Samsung Group, said Tuesday it has received approval to sell its biosimilar treatment for autoimmune disease in Japan. The biosimilar, which references U.S. biotechnology firm Johnson & Johnson's original drug Stelara, was approved under the product name Ustekinumab BS Subcutaneous Injection 45mg Syringes Nipro, the company said in a press release... Full

Alvotech Sees Out 2025 With Simponi Biosimilar Debut In Europe

(12/22, Dave Wallace, Generics Bulletin) ...Alvotech and commercialization partner Advanz Pharma have claimed a major first by announcing the European launch of a "first-in-market biosimilar to Simponi (golimumab) globally," in the form of their Gobivaz version of Johnson & Johnson's anti-TNF monoclonal antibody. While Alvotech specified that "launches are under way in Europe," specific markets were not identified other than the UK, where the firm said the roll-out of the pre-filled syringe and autoinjector would be "supported by a National Health Service England tender award."... Global Sub. Full

 

2025: The Year Trump Pushed Manufacturing Into the Spotlight

(12/23, Nick Paul Taylor, BioSpace) ...John Murphy, CEO of the Association for Accessible Medicines (AAM), an industry group for makers of generics and biosimilars, made a similar point. He told BioSpace that the realization the U.S. needs to prioritize manufacturing was his top trend of 2025. The acknowledgment has emerged in lockstep with rising understanding that the U.S. has medicine supply vulnerabilities because "we don't make much here," Murphy said. "We lead the world in generic drug shortages because of our problematic reimbursement system for medicines," he added. "We have very little capacity to manufacture API and [key starting materials] here in the United States, and so we are wholly reliant on a number of trading partners."... Full

BsUFA IV Is Coming: What's Next for U.S. Biosimilars? Key Takeaways from FDA's December 2025 BsUFA Reauthorization Meeting

(12/23, Fabiola C. Gomez, Ph.D., FDA Law Blog) ...FDA leadership emphasized that the biosimilars program continues to be a major driver of patient access and healthcare savings. Biosimilars have generated $56 billion in savings since 2015, including almost $20 billion in 2024 alone. Biosimilars lower costs in two ways: they enter the market at lower prices, and their presence also leads brand biologics to reduce prices, lowering overall spending... Full

Many Biosimilar Developers See US FDA Streamlining Positively, Some Concerned

(12/22, Dave Wallace, Pink Sheet) ...For nearly every major biosimilars developer, late October was defined by the US Food and Drug Administration's publication of new guidance streamlining the biosimilar approval process. Hailed at the time by industry representatives as a "momentous, critical step" for biosimilars, the FDA guidance explicitly states that comparative efficacy studies will no longer be the default requirement to support submissions under the 351(k) biosimilars pathway... Full

GDUFA IV: ‘Potential OAI' Classification Could Mean User Fee Goal Extension

(12/22, Derrick Gingery, Pink Sheet) ...The US Food and Drug Administration proposed a goal date extension of 120 days from the date of a surveillance inspection closure for generic drug applications where a facility named in the submission receives a "potential Official Action Indicated" (pOAI) designation. An application also could not have other major deficiencies and have an existing goal date falling "before the 90-day final classification due date for the final Establishment Inspection Report (EIR) classification," the FDA said during generic drug user fee reauthorization negotiations... Global Sub. Full

The FDA Often Doesn't Test Generic Drugs for Quality Concerns, So ProPublica Did

(12/22, Debbie Cenziper and Megan Rose, ProPublica) ...ProPublica decided to test several generic versions of three of the most widely prescribed drugs in the United States: the antidepressant bupropion XL, the generic for Wellbutrin XL; the heart medicine metoprolol succinate, the generic for Toprol XL; and the cholesterol drug atorvastatin, the generic for Lipitor. A total of 11 samples from readers, ProPublica employees and the independent testing lab Valisure were assessed, representing a cross section of manufacturers from around the world... Full

Pharmaceutical Industry Evades Drug Price Transparency, Again

(12/22, Bob Herman, STAT+) ...Drug manufacturers and pharmacy benefit managers received a holiday gift from President Trump on Friday: They still will not have to publicly post the actual prices of prescription drugs, more than five years after federal law required them to do so. Net drug prices — the amounts that health insurance companies and PBMs pay to drugmakers, after factoring in rebates — are highly valuable data that undergird the entire economic foundation of the U.S. pharmaceutical industry. But the decision from the Trump administration, rolled out in a new proposed rule, means that drug pricing data will likely remain locked out of public view for the foreseeable future... Sub. Req’d

Medicare ‘Most Favored Nation' Demos Aren't Worth the Price

(12/22, Sue Peschin, RealClearHealth) ...Last week, the Center for Medicare and Medicaid Innovation (CMMI) announced two new mandatory "demonstrations" that would impose foreign price controls on medicines covered by Medicare Parts B and D. The Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) would significantly restrict Medicare beneficiaries' access to lifesaving drugs and deter future research into diseases that disproportionately affect older adults... Full

AstraZeneca Sues US Over Drugs for Medicare Price Cuts Round 2

(12/22, Nyah Phengsitthy, Bloomberg Law) ...The complaint filed Dec. 19 in the US District Court for the District of Maryland alleges the Centers for Medicare & Medicaid Services acted unlawfully when it defined "qualifying single source drugs" under the Biden-era plan. The government selects qualifying single source drugs for the program, depending on how long they've been on the market. The drugs are high-cost, brand name products without generic or biosimilar competition... Sub. Req’d

Exclusive: Bristol Myers Brings IRA Fight to Supreme Court as 'Regime of Forced Sales' Is Poised to Take Effect

(12/22, Alexis Kramer, Endpoints News) ...Bristol Myers Squibb is the second drugmaker to take its Inflation Reduction Act challenge to the Supreme Court, arguing that the program unlawfully forces it to sell its blockbuster blood thinner Eliquis at a steep discount. "Congress wanted to obtain medicines for Medicare beneficiaries without paying fair market value," BMS wrote in a petition obtained by Endpoints News. "To that end, the Program hoists a menacing ‘sword of Damocles' over any manufacturer whose product has been chosen for ‘negotiation.'"... Sub. Req’d

Benchmarking Drug Prices To Inflation Overlooks What Truly Matters: Value

(12/22, William V. Padula, Health Affairs) ...Every few months a new analysis lands with the same headline: launch prices for new drugs outpace inflation. The latest reported that the median net launch price for 154 medicines rose 51 percent from 2022 to 2024, faster than list prices over the same period, and that many exceeded benchmarks set by the Institute for Clinical and Economic Review (ICER) for treatments such as CAR-T therapies and GLP-1 inhibitors. That sounds damning, but it largely answers the wrong question... Full

Bipartisan, Bicameral Bill Aims To Cement PBM Fiduciary Duties

(12/22, Gabrielle Wanneh, Inside Health Policy) ...Lawmakers have introduced bipartisan legislation in the House and Senate long called for by employers that would ensure pharmacy benefit managers act in the best interest of employer health plans. The PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act would amend the Employee Retirement Income Security Act (ERISA) to clarify that PBMs must adhere to fiduciary responsibilities and act in the best interests of employees relying on employer-sponsored health plans. Employers have long said such legislation is necessary to rein PBMs' business conduct that contributes to plan enrollees paying higher prices than necessary for prescription drugs... Global Sub. Full

French Finance Bill Expected To Bring Increased Burden For Pharma

(12/22, Francesca Bruce, Pink Sheet) ...The latest version of France's 2026 social security finance bill is expected to increase the tax burden and impose stricter price controls on pharmaceutical companies, leading to a "more demanding regulatory and financial environment, which may deter investment or market entry," according to Alexandre Regniault, vice president of France Biotech. The bill comes as France continues to face a bleak economic outlook, with the social security deficit expected to reach €23bn ($19.6bn) in 2025, much higher than the €15.3bn deficit of 2024... Global Sub. Full

Aurobindo Pharma Raises Luoxin Aurovitas Stake to 50% With $5.12 Million Deal

(12/23, India Infoline) ...Aurobindo Pharma Ltd informed stock exchanges that its wholly owned subsidiary Helix Healthcare B.V. has entered into a binding agreement to acquire an additional 20 percent stake in Luoxin Aurovitas Pharma Chengdu Co Ltd in China for $5.125 million. Following the completion of the transaction, Helix Healthcare's ownership in the joint venture will increase to 50 percent from the current 30 percent. Luoxin Aurovitas is presently structured as a 30 is to 70 joint venture between Helix Healthcare B.V. and Shandong Luoxin Pharmaceutical Group Stock Co Ltd... Full

Lupin Doubles Down on Complex Drugs to Extend Growth Run

(12/22, Business Today) ...Lupin is increasing its focus on complex generics, biosimilars and specialty products as it seeks to sustain growth after a strong financial year. Vinita Gupta, CEO at Lupin told Business Today that the company's strategy is centred on high-barrier products, operational efficiency and selective expansion across key markets. FY25 built on the company's turnaround over the past two years. Consolidated sales rose 12.9% year-on-year to ?221,921 crore, while EBITDA margins improved to 24.7% from 20% in FY24. The company's market capitalisation touched a high in January 2025... Full

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