Monday, January 5, 2026

Canada Clears Generic Ozempic Production, but Pharmacies Won't Stock it Immediately

(1/2, The Canadian Press) ...Sandoz Canada, Apotex, Teva Canada, Taro Pharmaceuticals and Aspen Pharmacare Canada have all applied for Health Canada authorization, according to its list of generic submissions. Sandoz Canada and Teva Canada told The Canadian Press they couldn't provide any information on expected timelines for their products, while the others either could not be reached or did not respond to requests for comment... Full

Trump's Drug-Pricing Deals Won't Benefit Most Americans Today. They Could Over Time.

(1/4, David Lim, Politico) ...Trump administration health officials counter that some benefits for health care consumers will be revealed over time. In re-orienting how much countries worldwide pay for pharmaceuticals in the long run, they say, Americans who won't benefit right away will eventually pay lower prices as well. A key component of the Trump administration effort is to push other wealthy countries to pay more for drugs while pressuring drugmakers to use some of those profits to lower U.S. prices... Full

Trump's Year In Review: A Win Or Loss For Off-Patent Industry?

(1/5, Urte Fultinaviciute, Generics Bulletin) ...While the uncertainty over the tariff impact on biosimilars is keeping everyone on their toes, there have been regulatory proposals favoring off-patent biologics. In May, US senator Mike Lee proposed a bipartisan legislation aimed at having all biosimilars automatically designated as interchangeable upon approval. Granted, similar bills have been introduced several times before in previous years. The proposed bill received support from the AAM, with its CEO Murphy stating that "as the FDA has made clear, there is no clinically meaningful difference between biosimilars and interchangeable biosimilars."... Sub. Req'd

MFN Drug Pricing Update: After GENEROUS, GUARD AND GLOBE Issue From CMS's Innovation Center - Part I

(1/5, Alan M. Kirschenbaum & Sophia R. Gaulkin, FDA Law Blog) ...No conclusion can be drawn a priori on whether it will be advantageous for a manufacturer to submit international pricing data. On one hand, relying on CMS to determine the International Benchmark under the Default method may be advantageous because CMS's data sources will reflect list prices rather than the net prices submitted by manufacturers under the Updated method. On the other hand, the limited option of the Updated method produces a cross-country weighted average net price for use as an International Benchmark, which will be greater than the lowest single country weighted average net price under the streamlined option, and may even be greater than the lowest country Default benchmark that CMS derives from published list price data... Full

USPS Cuts Jeopardize Reliability Of Mail-Order Pharmacies

(1/2, Cara Smith, Inside Health Policy) ...Mail-order pharmacies have grown amidst a telehealth boom and a physician workforce shortage. But for patients who rely on mail-order pharmacies for essential medications, it is assumed that mail arrives on time. USPS is struggling to maintain timely deliveries as it faces budget cuts, despite adopting plans last year to modernize service and reduce costs... Sub. Req'd

Latest FDA Denosumab Decisions Offer Mixed Verdicts

(1/2, Dave Wallace, Generics Bulletin) ...Amneal and mAbxience have celebrated winning an endorsement from the US Food and Drug Administration for their Boncresa and Oziltus (denosumab-mobz) respective biosimilars to Amgen's blockbuster Prolia and Xgeva osteoporosis and bone cancer treatments... Global Sub. Full

OTC EpiPen? US FDA Open To Switching Epinephrine For Anaphylaxis

(1/2, Michael McCaughan, Pink Sheet) ..."Epinephrine has serious adverse effects, particularly cardiovascular," she noted. "It is given in a stressful emergency situation." The lengthy prescription label will not be easy to translate into the OTC "drug facts" format, [Office of Nonprescription Drugs Director Karen Murry] continued. "The user might not read the labeling ahead of time, and they must be able to figure it out quickly. Epinephrine is often given by the person experiencing the allergic reaction, but it might be given by a bystander with no prior experience with epinephrine."..."Despite these challenges, we are very willing to work with interested sponsors in this very important area," Murry emphasized... Global Sub. Full

A Closer Look At US FDA's 58 Novel Approvals In 2025

(1/2, Bridget Silverman, Pink Sheet) ...Priority review was granted to half of the 2025 approvals; counting the three applications using priority review vouchers would bring the priority share to 55%. In 2024, 57% of novel agents had priority reviews, or 61% including PRVs...The biggest differences can be seen for products qualifying for the FDA's marquee expedited review programs, the breakthrough therapy designation and regenerative medicine advanced therapy (RMAT) designation... Global Sub. Full

Pharmacy Benefit Managers Fight California Over Fiduciary Role

(1/2, Lauren Clason, Bloomberg Law) ...A California law imposing fiduciary duties on pharmacy benefit managers intrudes on federally regulated health insurance plans, the Pharmaceutical Care Management Association said in a lawsuit filed Friday... Sub. Req'd

Servier Taps Insilico's AI Platform for Early Cancer R&D

(1/5, Ayisha Sharma, Endpoints News) ...Insilico will get up to $32 million in upfront and near-term payments and is eligible for additional payments that could bring the deal's value up to $888 million. Insilico will use its AI platform to identify potential drug candidates that act on "challenging" targets in oncology, according to a Sunday release... Sub. Req’d

Ironwood Surges After Forecasting Linzess' Reentry into Blockbuster Territory

(1/2, Anna Bratulic, FirstWord PHARMA) ...The company said it expects US net sales of Linzess to reach between $1.125 billion and $1.175 billion this year, up from its 2025 projection of $860 million to $890 million. Total revenue is forecast to climb to $450 million to $475 million, compared to 2025 full-year guidance of between $290 million and $310 million... Full

Sanofi Says FDA Agrees to Review Diabetes Drug Age Range; Company Says FDA Review Could Amend the Lower End of the Range for the Drug

(1/5, Aimee Look, The Wall Street Journal) ...Sanofi said the U.S. Food and Drug Administration accepted a priority review to potentially expand the current age range for its Tzield type-1 diabetes drug to include children as young as one year old. The French pharmaceutical company said Monday that the FDA's review could amend the lower end of the range for the drug, which is currently approved for children as young as eight years old... Sub. Req’d

Novo Nordisk Launches Wegovy Pill for as Little as $25 a Month for Insured Patients

(1/5, Elizabeth Cairns, Endpoints News) ...Novo Nordisk will launch the pill form of its obesity med Wegovy in the US on Monday, saying that it could cost insured patients as little as $25 per month. Prescriptions for the pill can be filled from 8 a.m. ET... Sub. Req’d

Outlook Left Adrift With Another FDA Rejection For Lytenava

(1/2, Dave Wallace, Generics Bulletin) ...The latest development in the long saga of Outlook Therapeutics' attempts to secure US [FDA] approval for an ophthalmic formulation of bevacizumab has seen the agency once again reject the firm's ONS-5010/Lytenava (bevacizumab-vikg), just weeks after the latest resubmission. The US agency has issued a complete response letter indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration, representing the latest in a long line of knockbacks for the product, which is intended to provide an alternative to the off-label use of Avastin and its biosimilars by ophthalmologists... Global Sub. Full

Viatris Scoops FDA Octreotide Approval, Files Low-Dose Contraceptive Patch

(1/5, Dean Rudge, Generics Bulletin) ...Viatris has racked up several key regulatory milestones, including a key - yet delayed - US Food and Drug Administration complex generic approval, multiple late-stage regulatory acceptances, and a green light for an early-stage gene therapy program... Global Sub. Full

Formycon Reveals Another Lucentis Biosimilar With Zydus As A New US Partner

(1/5, Urte Fultinaviciute, Generics Bulletin) ...Formycon finished the year with another strong announcement, or rather two. The US Food and Drug Administration approved its second ranibizumab biosimilar, and it will be commercialized with its already established partner Zydus Lifesciences Limited. Under the agreement, Formycon's joint venture Bioeq will be responsible for the development, manufacturing, registration, and supply of the finished product... Global Sub. Full

Biogen's Tysabri to Be Used on England's NHS for Highly Active MS

(1/5, Robert Barrie, Pharmaceutical Technology) ...The National Institute for Health and Care Excellence (NICE) has recommended natalizumab as an option for adults with highly active multiple sclerosis (MS), a move that expands the drug's use in patients with the chronic autoimmune disease. Two versions of natalizumab are set for use on the NHS following the decision - Biogen's Tysabri and biosimilar Tyruko, the latter made by Sandoz. Tysabri is given as an injection, while Tyruko is administered as an infusion... Full

CivicaScript Announces Availability of Low-Cost Insulin and Biosimilar for Chronic Inflammatory Conditions in the US

(1/5, CivicaScript) ...Civica insulin glargine-yfgn is available in prefilled pens at the lowest list price in the current long-acting insulin market. CivicaScript is selling it to pharmacies across the United States for $45 for a box of five pens - a significant discount in many cases to current prices...CivicaScript sells ustekinumab-aauz in pre-filled syringes for subcutaneous injection in two strengths. The Wholesale Acquisition Cost for a 12-week supply of 90 mg is $985 and the WAC for a 12-week supply of 45 mg is $575... Full

Samsung Bioepis Denies Organon Deal Rumors

(1/5, Dave Wallace, Generics Bulletin) ...[I]n response to Generics Bulletin queries asking whether Samsung Bioepis was considering acquiring Organon or its biosimilars marketing business, a spokesperson for Samsung Bioepis told Generics Bulletin that "we would like to clarify that the market rumors are not true."... Global Sub. Full

Korean Biopharma Eyes Partnerships, Licensing at J.P. Morgan Conference

(1/4, Kan Hyeong-woo, The Korea Herald) ...Samsung Biologics CEO John Rim is expected to lay out plans for this year along with a mid- to long-term vision, while underscoring the firm's steady growth and industry-leading CDMO capabilities...Celltrion, the only other Korean company to present at the Grand Ballroom, is expected to describe its roadmap for future growth and pipeline expansion amid intensifying competition in the global biosimilar market. Celltrion CEO Seo Jin-seok, the oldest son of Celltrion founder and Chair Seo Jung-jin, is expected to highlight the company's strategies... Full

Generic Ozempic Production an ‘Exciting Time for Canada,' Doctor Says

(1/5, Tammy Ibrahimpoor, CTV News) ...Drug companies in Canada are allowed to make lower-priced generic versions of Ozempic starting this week. As of Dec. 29, Health Canada had received nine submissions seeking approval to make semaglutide, the active ingredient in Ozempic and Wegovy, the brand-name diabetes and weight-loss drugs manufactured by Novo Nordisk... Full

Indian Pharma to Grow 9-11% in 2026; To Focus on Quality, Sustainability and Market Diversification

(1/4, P B Jayakumar, Fortune India) ...India's pharmaceutical industry, valued at nearly $60 billion and the world's third-largest by volume and a leading global supplier of generic drugs and vaccines, plans to focus on quality, sustainability, and market diversification as key export priorities in 2026... Full

Quality of Generic Drugs as Good as That of Costlier Branded Cousins: Study

(1/5, Anuja Jaiswal, The Times of India) ...A citizen-funded quality study of commonly prescribed medicines has found no difference in quality between expensive branded drugs and the far cheaper generics, including govt supplied medicines, even as prices of some top brands can be as much as 14 times higher for the same drug... Full

Study Finds Generic Drugs Match Branded Quality, Cost Far Less, Revives Debate

(1/5, Sumi Sukanya Dutta, India Today) ...The project, led by Mission for Ethics and Science in Healthcare (MESH)—a network of biomedical experts, mathematicians, clinical researchers, lawyers, doctors, and scientists—tested 131 medicines across 22 therapeutic categories... Full

NHC Unveils 4th Catalog of Branded Drugs to Boost Generic Alternatives

(1/5, Wang Xiaoyu, China Daily) ...The list, jointly issued by the commission and three other government bodies, includes 21 branded medicines in fields such as oncology, neurology, assisted reproduction and diagnostic imaging... Full

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