Friday, March 22, 2024

GSK Is Third Major Inhaler Maker To Cap Copays; Will Teva Follow?

(3/21, Cathy Kelly, Pink Sheet) ...It's unclear whether a fourth inhaler manufacturer in the category will follow suit. Teva, which markets the AirDuo and ArmonAir Digihalers, has not yet announced similar plans for its drugs but it may make sense from a competitive standpoint. A comparable mass move to lower cost sharing for insulin ultimately did involve all the major players. The Sanofi, Eli Lilly and Novo Nordisk insulin copay announcements were all within three weeks of each other in March 2023, so Teva has until the end of the month if the inhaler category sweep is going to move at the same pace... Sub. Req'd

GSK Joins AstraZeneca, Boehringer in Capping US Out-Of-Pocket Inhaler Prices at $35 Per Month

(3/21, Zoey Becker, Fierce Pharma) ...Amid congressional scrutiny on U.S. inhaler prices, GSK is the latest pharma giant to commit to capping patients' monthly payments for its portfolio of asthma and chronic obstructive pulmonary disease meds...With the move, three leading inhaler manufacturers have committed to the $35 out-of-pocket monthly price cap. A fourth drugmaker, Teva, was also included in the HELP committee's January investigation into the "outrageous" costs for asthma and COPD products on the U.S. market... Full

Third Inhaler Company Caps Prices at $35 a Month After Baldwin's Investigation into High Costs

(3/21, U.S. Senator for Wisconsin Tammy Baldwin) ...U.S. Senator Tammy Baldwin (D-WI) applauds GlaxoSmithKline's announcement that Americans throughout the country with asthma and COPD will pay no more than $35 for the brand name inhalers they manufacture...Earlier this year, Senator Baldwin also called on the four biggest inhaler companies to stop unfairly locking out generics from the market and driving up the cost of inhalers for Americans. Specifically, in letters to AstraZeneca, Boehringer Ingelheim, GSK, and Teva, Senator Baldwin called on the companies to stop improperly listing patents for inhalers in the Orange Book and stifling competition... Full

EXCLUSIVE | Novartis CEO Says India Holds Incredible Strategic Potential in Pharma R&D

(3/21, Shereen Bhan and Pihu Yadav, CNBC TV 18) ...India might not be one of the priority markets for pharmaceutical giant Novartis, but Global CEO Vasant Narasimhan said that it has become "incredibly strategic" for the company's research and development efforts. "When you look at our performance last year, 10 positive phase three trials, and every one of those trials was touched by our Indian operations. Every one of those trials, the submissions of those trials to global regulators happens through our Hyderabad centre. We get some of the best talents in the world here," Narasimhan told CNBC-TV18 in an exclusive interview... Full

Sandoz Biosimilar Earnings Jump 15% in 2023

(3/21, Skylar Jeremias, The Center For Biosimilars) ...Sandoz revenues increased 7% overall last year, including a 15% spike in biosimilar sales, according to the company's earnings report for the fourth quarter (Q4) and full year (FY) 2023. Additionally, the company's overall revenue for Q4 2023 was up 10% from the same quarter in 2022, with net sales reaching $2.5 billion. Net sales for FY 2023 reached $9.6 billion, including $2.2 billion from biosimilars and $7.1 billion from generics... Full

Is Stada Laying The Ground For Future Sale With Russia Business Spin Off?

(3/21, Dean Rudge, Generics Bulletin) ...Privately-held STADA Arzneimittel AG has disclosed that it last year jettisoned its Nizhpharm operation in Russia to a subsidiary of its parent company Nidda, in a move the German firm said would make the Russian units "more flexible and adaptable to the rapidly changing business and regulatory environment," chiefly amid the "geopolitical uncertainties" stemming from the war in Ukraine... Global Sub. Full

Celltrion USA Submits Biologics License Application for CT-P39, A Biosimilar to Xolair

(3/21, Ashley Gallagher, Pharmacy Times) ...Celltrion USA announced the FDA submission of a biologics license application for CT-P39, an interchangeable biosimilar candidate to omalizumab (Xolair; Genentech, Roche), according to a press release. The BLA includes all indications for Xolair, including asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria... Full

Geo-Young and Samsung Bioepis to Collaborate On Biosimilar Distribution

(3/22, Yang Hyeon-su, Korea Biomedical Review) ...Geo-Young, Korea's largest pharmaceutical distributor, said Friday that it has signed a third-party logistics (3PL) contract with Samsung Bioepis for biosimilar drugs and started shipping the first batch...Geo-Young will distribute three biopharmaceuticals working as autoimmune disease treatments (TNF alpha inhibitor) -- Etoloce (etanercept), Remaloce (infliximab), and Adalloce (adalimumab). According to Geo-Young, these biopharmaceuticals are sensitive to temperature and humidity, so a top-notch cold chain system is essential to prevent product damage and deterioration during transportation... Full

India Pharma Quality Lapses Force U.S. to Look to China for Lifesaving Drugs

(3/22, Sayan Chakraborty and Cissy Zhou, Nikkei Asia) ..."If Indian drugmakers really want to cater to overseas markets, it is very important they adhere to global standards, however stringent," Brajesh Singh, an associate director at consultancy Arthur D. Little, told Nikkei. "It will be an opportunity lost if they don't … because the ‘China plus one' policy really makes it India's moment to seize," Singh said, referring to a strategy in which companies reduce their dependence on China by diversifying their supply chains to other countries... Full

Endo Starts Fresh As Financial Restructuring Plan Gets Confirmed

(3/21, Urte Fultinaviciute, Generics Bulletin) ...The US Bankruptcy Court for the Southern District of New York has confirmed Endo's Chapter 11 reorganization plan. This will allow the bankrupt company to complete the financial restructuring by selling substantially all assets to a new entity, Endo, Inc., of which 95% is owned by holders of the company's first lien debt..."We look forward to emerging as Endo, Inc., a stronger company poised for sustained growth. We are grateful for the collaboration and support from our many stakeholders throughout this process," said Endo's CEO Blaise Coleman... Global Sub. Full

Mylan Investors' Appeal Draws Scrutiny from Second Circuit Panel

(3/21, Ben Miller, Bloomberg Law) ...Mylan N.V. investors' attempt to revive class action claims that the pharmaceutical company hid price fixing practices and fraud related to EpiPen rebates received push back from a panel of Second Circuit Judges on Thursday, who appeared unreceptive to rationales for overturning a lower court's ruling during oral arguments... Sub. Req'd

Drug Delays, Skyrocketing Prices An Ongoing Effect of Massive Cyberattack

(3/22, Justin P. Hicks, MLive) ...Frustrated patients in Michigan and around the country have had to pay out of pocket for medicine for chronic diseases and other illnesses or go without in the fallout from a cyberattack of a major health care company. The tech company, Change Healthcare, has restored access to many of its systems in the weeks since the Feb. 21 attack announcement. However, some services remained down as of Thursday, March 21, including the system that processes discount/savings cards to bring down drug prices for patients... Full

Albertsons Joins Mark Cuban's Pharmacy Network

(3/21, Paige Twenter, Becker's Hospital Review) ...Mark Cuban Cost Plus Drug Co. expanded its pharmacy network March 20 with a deal with grocery chain Albertsons, growing its drug discount offering by another thousand-plus locations...With the recent Albertsons deal, 1,728 pharmacies across 34 states now accept the company's Team Cuban Card, according to a LinkedIn post... Full

Setbacks For Pharmaceutical Industry In Challenges To Medicare Drug Price Negotiations

(3/21, Zachary Baron Sheela Ranganathan, Health Affairs) ...At this stage, it seems highly unlikely that an appellate court would issue a decision before the Administration publishes any agreed-upon negotiated prices for the selected drugs by September 1, 2024. However, since such negotiated prices will not take effect until 2026, the pharmaceutical industry still has plenty of time to secure a legal victory that could thwart the implementation of the negotiation program and mitigate savings for older Americans and the federal government... Full

The D.E.A. Needs to Stay Out of Medicine

(2/22, Shravani Durbhakula, The New York Times) ...Dangerous prescription drugs require safeguards, but a scalpel has more promise than a sledgehammer. The D.E.A., an agency staffed with law enforcement officials, is not equipped to distinguish appropriate from inappropriate prescribing, and it has in the past apparently confused inappropriate with criminal. Instead of itself defining medical aptness, the D.E.A. should pass the baton to our nation's public health agencies. Collaboratively, the Centers for Disease Control and Prevention, the Food and Drug Administration and the Department of Health and Human Services can take a tailored, more precise approach to opioids that is informed by medical and clinical acumen... Full

Industry Clamors for Clarity On FDA's Advanced Manufacturing Designation Program

(3/21, Emily Hayes, Regulatory Focus) ...Industry is welcoming of the US Food and Drug Administration's upcoming advanced manufacturing technologies program but is clamoring for more clarity on crucial details like what methods will be covered, which sponsors can take part, and how fast it would work..."The general efforts of the FDA to encourage the early adoption of advanced manufacturing technologies are welcome by industry, and this guidance could represent another element of this effort to enable faster launches and a robust supply chain through new manufacturing technology," wrote the Biotechnology Innovation Organization, one of 25 commenters... Full

US FDA Advisory Panels May Look Different Across Centers, Despite Efforts To Standardize Process

(3/21, Kate Rawson, Pink Sheet) ...As FDA is readying to go back to in-person advisory committee meetings this fall, the centers have different ideas about how to use their expert panels...Most of FDA's efforts to revamp adcomms has taken place behind the scenes, with now-Principal Deputy Commissioner Namandjé Bumpus heading the effort. While OCE tends to use advisory committees to highlight "problem applications," CBER relies on its committees as a public health outreach tool. ODAC often needs expertise in trial design more so than disease experts, but CDER committees will rely on physicians who have worked with patients who have the particular disease at issue... Sub. Req'd

Kentucky is the Fourth State to Allow Insurers to Require Biosimilar Prescriptions Before Branded Versions

(3/21, Lia DeGroot, Endpoints News) ...Governor Andy Beshear signed the bill into law last week, joining Arkansas, California and Louisiana in passing similar legislation that aims to remove barriers to biosimilars. Specifically, the law now states that biosimilars, generics and interchangeable biologics can be substituted for a reference product...The Association for Accessible Medicines' Biosimilars Council welcomed the passage of Kentucky's law, saying it will make medicines more affordable for patients while preventing misuse of step therapy, which prioritizes lower-cost medicines over branded versions... Full

PCMA Releases Statement on Kentucky House Bill 220

(3/21, PCMA) ..."PCMA applauds the legislature in Kentucky and Governor Beshear on the passage of HB 220, which expands on a previous version of the bill. The legislation will improve patient access to affordable prescription drugs by allowing health plans the flexibility to encourage patients to use generic and biosimilar products.”... Full

States' Drug Pricing Boards Off to a Slow Start

(3/22, Maya Goldman, Axios) ...Five years after the creation of the first state board empowered to cap prescription drug costs, patients still haven't seen any savings from these efforts...Even as more blue and purple states embrace public drug pricing boards amid angst over high medicine costs, it could still be months or even years before they start to bring down prices. The big picture: Political roadblocks, pharmaceutical industry pushback and cumbersome regulatory processes have slowed down efforts across the country, insiders said... Full

R.I. Could Be The Next State to Establish a Prescription Drug Affordability Board

(3/21, Alexa Coultoff, Boston Globe) ...As prescription medication costs rise across the country, many states have introduced legislation to create prescription drug affordability boards to help regulate prices, including Rhode Island. AARP officials gave an update on the progress of these boards during a press conference Wednesday, where they said 11 states have prescription drug review boards in place. Four of those states have the ability to establish upper-payment limits, a limit on what purchasers can pay for certain drugs in the state separate from the manufacturer's list price — and the price other states may set... Full

Should Michigan Get into the Insulin Business? Dropping Market Prices Could Thwart Plan

(3/21, Dustin Walsh, Crain's Grand Rapids Business) ...With 13% of the Michigan population living with diabetes, state legislators are embarking on a bold strategy to ensure ample production and affordability of insulin...VanderWall believes Michigan's plan will result in insulin costs down below $50 per month for most Michiganders. He said while price caps and generic insulin options help, there are still too many loopholes for diabetes patients... Sub. Req'd

‘Imperfect Compromise' On EU Pharma Legislation Still Offers Progress

(3/21, David Wallace, Generics Bulletin) ...Reacting to the latest position on the EU pharma legislation overhaul adopted by a European Parliament committee – including changes to previous proposals on regulatory data protection – Medicines for Europe said that the "imperfect" compromise nevertheless offers improvements... Global Sub. Full

EU Pledges More Money To Support African Medicines Agency

(3/21, Ian Schofield, Pink Sheet) ...The creation of the African Medicines Agency received another boost this week after the European Commission and the Belgian presidency of the Council of the EU announced funding of €10m ($10.9m) and €4m respectively for the new body...The AMA is intended to support the growth of local pharmaceutical production and help local and regional bodies build up their capacity to regulate medicines and other health products. It will also coordinate joint reviews of clinical trial applications for vaccines and "highly complex" products such as biosimilars, and help to identify substandard and falsified medical products, according to AUDA-NEPAD... Sub. Req'd

National Real-World Evidence Frameworks For HTA Should Be Consistent, Not Identical

(3/21, Eliza Slawther, Pink Sheet) ...There is "more that can be done" by health technology assessment (HTA) bodies such as England's NICE to ensure that real-world evidence frameworks are consistent with those of other global agencies, Sarah Jenner, a principal at consulting firm IQVIA, said during a virtual Westminster Health Forum event. In particular, greater standardization among HTA bodies on the acceptance of RWE could "help improve the speed and access to medicines through these quite lengthy HTA processes," Jenner contended, although she emphasized that there was a "balance to be struck."... Sub. Req'd

UK Risks Critical Medicine Shortage as EU Lures Drugmakers

(3/22, Ashleigh Furlong and Angela Feliciano, Bloomberg) ...The European Union last year proposed legislation to fund new investments and repatriate production of drugs deemed essential. If the UK doesn't take steps to make the country attractive to companies, it will face further shortages, said Diane DiGangi Trench, who heads Sandoz Group AG in the UK. "We're fighting for supply with the likes of Europe and the US," she said in an interview. "If there's only so many critical medicines that are available and if the UK doesn't make the market more sustainable or commercially viable, I think ultimately it will lose out." The UK government has pushed to spur life-science innovation, championing companies like AstraZeneca Plc and GSK Plc. But it's not supporting makers of generics the same way, DiGangi Trench said, even though these medicines account for most of the shortages... Full

BRIEF—Sandoz Opens New Antibiotic Production Facility in Austria

(3/21, The Pharma Letter) ...Swiss generic and biosimilar medicines maker Sandoz today opened a new production facility in Kundl, Austria, to serve more patients with affordable life-saving drugs produced entirely in Europe...The opening of the new facility is part of a 200 million-euro investment into the site in Kundl, to significantly upgrade penicillin API manufacturing and increase output of finished products, in order to better serve patients in more than 100 countries worldwide... Full

Brazil Issues Guidance On Regulatory Reliance & Equivalent Authorities

(3/21, Francesca Bruce, Pink Sheet) ...In the latest move to advance regulatory reliance in Brazil, the country's medicines regulator, Anvisa, has approved new guidance setting out criteria for making use of pre- and post-market drug evaluations carried out by the foreign authorities it deems to be "equivalent" regulatory bodies. The guidance, published this week, relates to registration and post registration studies of medicines, vaccines and biological products... Sub. Req'd

Quality Assurance of Pharmaceuticals: WHO Releases New Guidelines

(3/21, World Health Organization) ...The "10th edition of the Quality assurance of pharmaceuticals: a compendium of guidelines and related materials" aims to strengthen pharmaceutical standards globally, including in Indonesia. The compendium has been developed for the use of national regulatory bodies, pharmaceutical manufacturers, healthcare practitioners and procurement agencies and will help maintain internationally recognized standards of Good Manufacturing Practices and inspection procedures... Full

Pharma Pivot on Pandemic Agreement: ‘Free Access' to Pathogens in Exchange for ‘Binding Obligation' On Equity

(3/21, Elaine Ruth Fletcher, Health Policy Watch) ...Pharmaceutical giants could support a formula whereby companies are guaranteed free and immediate access to pathogens with pandemic potential in exchange for binding equity agreements as part of a proposed World Health Organization pandemic agreement, says a leading industry figure. The statement by Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, aims to turn the classic formula for industry pathogen access in exchange for benefit-sharing on its head... Full

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