Tuesday, July 23, 2024

Gedeon Richter Is Latest To File European Denosumab

(7/22, David Wallace, Generics Bulletin) ...Gedeon Richter has become the latest firm to throw its hat into the ring for a denosumab biosimilar, after revealing that the European Medicines Agency has accepted for review the firm's two marketing authorization applications for proposed rivals to Prolia and Xgeva...In May, Shanghai Henlius Biotech disclosed that the EMA had validated a denosumab filing that it submitted with partner Organon, while other firms such as Biocon, Boan Biotech, Celltrion, mAbxience, Samsung Bioepis and Teva are also developing denosumab biosimilars... Global Sub. Full

And They're Off! First Stelara Biosimilar Enters European Markets

(7/22, David Wallace, Generics Bulletin) ...Alvotech and Stada have celebrated their debut launch of biosimilar competition to Stelara (ustekinumab) in Europe, with the introduction of the firms' partnered Uzpruvo version "across a majority of European countries." While the specific launch markets were not disclosed, the firms said the initial roll-out covered "the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry."... Global Sub. Full

FDA Approves Epysqli As Second Soliris Biosimilar

(7/22, Skylar Jeremias, The Center For Biosimilars) ...The FDA approved Epysqli (eculizumab-aagh), a biosimilar developed by Samsung Bioepis that references Soliris (eculizumab), for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The approval marked the second for an eculizumab biosimilar, following the May 2024 approval of Bkemv (eculizumab-aeeb). Epysqli is also the eighth US biosimilar approval for Samsung Bioepis, following biosimilars for etanercept, infliximab, adalimumab, trastuzumab, bevacizumab, ranibizumab, aflibercept, and ustekinumab... Full

Krka Enjoys 9% Pharma Sales Growth At The Half-Way Stage

(7/22, Dean Rudge, Generics Bulletin) ...Krka believes that its financial results for the first six months of the year "are encouraging and that we will meet our plans for 2024," after its prescription Pharmaceuticals sales rose by 9% to €823.4m ($897m), helping towards a "strong group EBITDA margin of 28.8%, which is well above the strategic guidance."... Global Sub. Full

Drug Giants Eye China for Deals Despite Growing Sino-US Tensions

(7/22, Andrew Silver and Kane Wu, Reuters) ...Some of the biggest global drugmakers, undeterred by mounting Sino-U.S. tensions, are scouring for deals in China to replenish drug pipelines and boost their presence in the world's second-biggest pharmaceutical market, industry executives and investment bankers said. Several major deals have already been completed this year, including AstraZeneca's $1.2 billion purchase of China-based cell therapy developer Gracell Biotechnologies and Novartis' acquisition of remaining shares of kidney disease therapy developer SanReno Therapeutics for an undisclosed amount... Full

Celltrion's New Plant in Songdo Poised for Commercial Production

(7/23, Jeong Min Nam, The Korea Economic Daily) ...South Korea's largest biosimilar maker Celltrion Inc. said on Tuesday that its third plant in Sondgo, west of Seoul, is undergoing process valuation testing, or the final stage of inspection, before starting commercial production in December this year...The new factory will raise the drugmaker's biologics production from cell culture incubators to 250,000 liters a year, including 100,000 liters from the first plant and 90,000 liters from the second one on the Songdo campus... Full

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) Bags Due to an Individual Unit of Acetaminophen Overwrap Found to Have Contained a Labelled Bag of Dexmedetomidine HCL Injection (400mcg/100mL)

(7/22, Hikma) ...Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending its voluntary recall of one lot of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) to the consumer/user level. The product is being recalled due to the potential presence of a bag labelled Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL)... Full

Drug Middlemen Push Patients to Pricier Medicines, House Probe Finds

(7/23, Liz Essley Whyte, The Wall Street Journal) ...The drug middlemen that promise to control costs have instead steered patients toward higher-priced medicines and affiliated pharmacies—steps that increase spending and reduce patient choice, a House investigation found...The PBMs have also made patients pay more to use their local pharmacy rather than a mail-order pharmacy affiliated with the manager, according to a committee report reviewed by The Wall Street Journal. Among the evidence cited by the committee were emails from staff at Cigna Group's Express Scripts discouraging discussion of using lower-priced alternatives to the arthritis drug Humira... Sub. Req'd

PBM Schemes to Control Biosimilar Humira Are Denying Patients Savings – New Analysis Shows PBM Strategies and Brand ‘Product Hopping' Are Suppressing Uptake of Lower Cost Biosimilar Adalimumab

(7/22, Biosimilars Council) ...The analysis of adoption trends among lower-cost biosimilar versions of Humira® shows that leading PBMs continue to prefer the high-priced brand despite biosimilar alternatives with discounts of more than 80 percent. Further, even though a major PBM has adopted a biosimilar, its adoption still trails that of PBMs and health plans that are not dependent on rebates, and it has used the biosimilar to drive more patients into its own pharmacies and away from competitor pharmacies... Full

PBM Execs to Take Their Turn in the Hot Seat

(7/22, Peter Sullivan, Axios) ...Top executives of the three major PBMs will testify: Adam Kautzner, president of Express Scripts, David Joyner, president of CVS Caremark and Patrick Conway, CEO of OptumRx...Expect the PBMs to try to shift the focus to drug manufacturers, which they say set the list prices that are a starting point in negotiations, and to defend their function as lowering costs, not raising them...Kautzner plans to highlight Express Scripts data showing that consumers with employer-sponsored coverage paid less out of pocket for drugs in 2023 than in 2022, and that the average cost of a 30-day prescription was $15... Sub. Req'd

Oversight Committee Hearing On PBMs Could Help Patients and Independent Pharmacies

(7/22, Todd Stephens, RealClearHealth) ...Earlier this month, the Federal Trade Commission released an interim report on the impact of pharmacy benefit managers on the accessibility and affordability of prescription drugs. Now, the House Oversight Committee has called the "Big 3" PBMs, which control the processing of nearly 80% of all Americans' prescriptions, to testify on July 23. Will this finally be a turning point for patients, or will the committee ask the same old questions that will be dismissed with the same canned answers the public has heard for years... Full

Drugmakers' Price Fight Draws Amicus Support in Third Circuit

(7/22, Nyah Phengsitthy, Bloomberg Law) ...Bristol Myers Squibb Co., and Johnson & Johnson received a flood of support in their lawsuits seeking to scuttle a government drug price-setting program as various amicus briefs were filed in their favor at the Third Circuit...Drugmaker Teva Pharmaceutical also filed a brief in support of the drugmakers and AstraZeneca PLC, arguing the program will stifle generic and biosimilar competition through "marketing-distorting coercion."..."Perhaps most troubling, under CMS's remarkable reading of the IRA, the launch of multiple biosimilar versions of STELARA in early 2025 will provide no relief from government price mandates," Teva wrote... Sub. Req'd

Experts Pushing To Expand Congress' Role Post-Chevron To Testify At House Hearing

(7/22, Sigi Ris, InsideHealthPolicy) ...Policy experts who believe lawmakers should expand their regulatory oversight will testify at a House Administration Committee hearing Tuesday (July 23) on Congress' evolving role in a post-Chevron era, and ideas likely to be floated include the creation of a congressional Office of Legal Counsel or Office of Regulatory Review, as well requiring agencies publish information that informed the writing of their rules and conduct retrospective reviews of significant rules... Sub. Req'd

FDA: Makers Of Interchangeable Drugs Can Use Biosimilar Process For Manufacturing Changes

(7/22, Jessica Karins, InsideHealthPolicy) ...A new FDA guidance details a process for how manufacturers of biosimilar and interchangeable drugs should notify the agency of manufacturing changes similar to the process laid out in the Public Health Service Act for innovator drugs, telling drug makers they must demonstrate that the biosimilar or interchangeable remains comparable to its reference product and does not lose quality, safety or efficacy... Sub. Req'd

Biosimilars: FDA Draft Guidance Addresses Manufacturing Changes

(7/22, Joanne S. Eglovtich, Regulatory Focus) ...The Q&A addresses the different postapproval reporting categories; FDA differentiates post-approval changes into three categories: major changes requiring the filing of a prior approval supplement (PAS); moderate changes require the filing of a changes being effected-30 days supplement (CBE-30); and minor changes requiring only the filing of an annual report. The guidance also discusses the type of reference materials applicants should submit to compare pre- and post-change material... Full

Sinking Prices for Generic Meds a Major Factor in US Shortage Crisis: Report

(7/22, Fraiser Kansteiner, Fierce Pharma) ...As lawmakers and industry groups seek to get a handle on U.S. drug shortages, a new white paper from German market analytics firm QYOBO supports the thesis that disproportionately low prices for generic medicines can make it difficult for drugmakers to keep supplies afloat...Of drugs that have fallen into short supply in recent years, 83% saw their net sales prices slip between 2020 and 2022, according to QYOBO. Conversely, 17% of shortage-affected drugs have seen net price increases during that stretch... Full

We're Closer Than Ever To Beating Alzheimer's. Price Controls Could Change That.

(7/22, Sally Pipes, Forbes) ...Donanemab's approval comes about a year after the agency gave the green light to lecanemab, another monoclonal antibody proven to slow the progression of Alzheimer's. Eisai and Biogen are marketing it as Leqembi...In a 2022 paper, economists Tomas J. Philipson and Yier Ling found that delaying the onset of mild to moderate Alzheimer's by just one year could save around $34,000 per Alzheimer's patient over the course of a decade. That adds up to as much as $637 billion in savings over that same period. Those mammoth savings will never materialize if price controls reduce or eliminate the incentive for companies to invest in drug development... Full

WuXi AppTec More Than Tripled Lobbying Spend as Biosecure Act Advanced in Congress

(7/22, Jared Whitlock and Zachary Brennan, Endpoints News) ...China's WuXi AppTec spent at least $360,000 lobbying on the Biosecure Act and other bills before Congress in the second quarter, significantly upping its lobbying work as the company pushed back against the legislation targeting it and other Chinese biopharma contractors...A PhRMA spokesperson said the lobbying group is working with Congress to ensure the bill doesn't cause any shortages or disruptions to R&D... Full

Virginia Beach Enters Litigation Over Insulin Maker, PBM Pricing

(7/22, Celine Castronuovo, Bloomberg Law) ...Insulin manufacturers Eli Lilly & Co., Novo Nordisk A/S, and Sanofi SA have worked together with PBMs CVS Caremark, Express Scripts, and OptumRx to promote a drug pricing system that encourages drugmakers to pay higher rebates to PBMs in exchange for better placement on a health plan's list of covered drugs, or formulary, the city and school board of Virginia Beach argued in their complaint filed July 19 in the US District Court for the District of New Jersey...CVS spokesperson Mike DeAngelis said the PBM plans to fight the lawsuit, arguing "pharmaceutical companies alone are responsible for the prices they set in the marketplace for the products they manufacture."... Sub. Req'd

House Moves to Limit Middlemen's Cut from Drug Sales, Pass Savings to Consumers

(7/22, Matthew Medsger, Boston Herald) ...At present, according to state House Speaker Ron Mariano, the way the prescription drug industry is structured serves only to line the pockets of PBMs, while many patients struggle to afford life-saving medications. "Many folks in Massachusetts face cost barriers in access to the medications they are prescribed, especially for many of our most vulnerable residents who live with chronic disease. This bill aims to reduce the out-of-pocket cost of certain lifesaving drugs and ban certain business practices that are commonly used by PBMs to increase their own profits at the expense of patients," Mariano, of Quincy, said in a statement... Full

EU Moment Of Truth For Lecanemab & 14 Other Drugs

(7/23, Neena Brizmohun, Pink Sheet) ...Eisai/Biogen could this week learn whether the European Medicines Agency will give the thumbs up to market lecanemab across the EU for early Alzheimer's disease. Following a protracted regulatory review, the European Medicines Agency is at last due to decide whether to recommend in favor of pan-EU marketing authorization for lecanemab, Eisai/Biogen's disease modifying treatment for early Alzheimer's disease... Sub. Req'd

EU Pharma Reform, SPCs, Compulsory Licensing Among Parliament's ‘Unfinished Business'

(7/22, Ian Schofield, Pink Sheet) ...On July 23,, each of the new European Parliament's 20 standing committees will hold a "constitutive" meeting during which they will elect a chair and up to four vice-chairs in preparation for the new legislative session. They include the committee on the environment, public health and food safety and the legal affairs committee, which together will be responsible for steering the parliament's discussions on the outstanding draft legislation of relevance to the pharmaceutical industry... Sub. Req'd

EMA Backs New Method For Measuring Alzheimer's Disease In Trials

(7/22, Eliza Slawther, Pink Sheet) ...Evidence generated through an EU public-private funding initiative has resulted in a new biomarker method for measuring the level of Alzheimer's disease in a person's brain, which drug developers can use during clinical trials...The European Medicines Agency has endorsed a new method for quantifying how much amyloid plaque is visible on a patient's brain scan, which could help researchers developing drugs for Alzheimer's disease to identify patients for clinical trials and evaluate how well treatments are working... Sub. Req'd

Pharma Sector Shows Resilience: Bulk Drug Exports Surge, Import Dependency Tackled with PLI Boost

(7/22, Abhishek Law, The Hindu BusinessLine) ...India is net exporter of bulk drugs in FY24, but the country continues to be dependent on imports for many antibiotic active pharmaceutical ingredients (APIs) manufactured through fermentation, the Economic Survey 2023-24 notes...The Economic Survey notes that PLI schemes for bulk drugs and pharmaceuticals have helped stabilise the import of bulk drugs and improved the supply chain resilience. Under the scheme, fermentation based manufacturing capabilities got strengthened through production of antibiotics such as Penicillin G and Clavulanic Acid... Full

Innovation One of the Key Drivers for Growth in Pharmaceutical Sector: Economic Survey 2024

(7/22, Naman Suri, Mint) ...Finance minister Nirmala Sitharaman on Monday tabled the Economic Survey 2023-24, which highlights the next leg of growth in the Indian pharmaceutical sector by advocating for innovation while maintaining India's position as a cost-effective and efficient producer of generic drugs, aligning with the vision of Viksit Bharat. "The R&D expenditure in India's drugs and pharmaceutical sector averaged around 5% of sales turnover in FY20 and FY21," the survey states. "As we move towards realising the vision of Viksit Bharat, it is vital to promote innovation."... Full

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