Tuesday, August 27, 2024

Express Scripts Follows CVS In Dropping Humira From Formularies

(8/27, David Wallace, Generics Bulletin) ...Express Scripts has announced plans to drop branded Humira from formularies in the US next year, in favor of biosimilar adalimumab rivals...When Humira is removed from the largest commercial formularies of Express Scripts in 2025, biosimilars available will include Boehringer Ingelheim's Cyltezo (adalimumab-adbm) and its unbranded version; Teva and Alvotech's partnered Simlandi (adalimumab-ryvk) version; Sandoz's unbranded adalimumab-adaz; and versions produced for Evernorth's Quallent Pharmaceuticals distributor through agreements with multiple manufacturers including Boehringer and Teva... Global Sub. Full

Cigna's Express Scripts to Cross Out AbbVie's Humira from Some Formularies in 2025, Opting to Go with Biosims Instead

(8/26, Zoey Becker, Fierce Pharma) ...Express Scripts, which is Cigna's pharmacy benefit unit, is removing branded Humira from its largest commercial formularies come 2025 in favor of biosimilar options from Teva, Sandoz and Boehringer Ingelheim...While the onslaught of biosimilar competition has led to a sizeable decline in AbbVie's Humira sales, the originator's remaining 82% market share shows that supplanting the entrenched product won't be easy for the biosimilar marketers... Full

Cigna to Remove AbbVie's Humira from Some Drug Reimbursement Lists Next Year

(8/26, Patrick Wingrove, Reuters) ...Cigna said Boehringer Ingelheim's Cyltezo, Simlandi from Teva and Alvotech, and an unbranded version of Hyrimoz from Sandoz  will be covered on some lists that are managed by its pharmacy benefits unit Express Scripts. Express will become the second major U.S. pharmacy benefits manager to stop recommending coverage of Humira, following similar action by CVS Health's  Caremark unit in April. That move led more patients to switch to biosimilar versions of Humira in three weeks than had in the prior 15 months... Full

Express Scripts to Remove Humira from Commercial Formularies

(8/26, Denise Myshko, Managed Healthcare Executive) ...Beginning in 2025, Express Scripts will remove Humira (adalimumab) from its commercial formularies, favoring instead several biosimilars. Biosimilars that will be available include...Simlandi (adalimumab-ryvk) (Teva), the first interchangeable biosimilar with Humira, high concentration, 40mg strength...Earlier this year, both Boehringer Ingelheim and Quallent entered into agreements to provide Express Scripts with private-label options of the Humira biosimilars... Full

Regeneron's Linvoseltamab CRL Underlines Risks Of Third-Party Manufacturers

(8/26, Bridget Silverman, Pink Sheet) ...The FDA's complete response for Regeneron's linvoseltamab rests on findings from an inspection for another company's candidate that uses the same third-party manufacturer, echoing previous CRLs for Checkpoint's cosibelimab and Lilly's lebrikizumab. While third-party contract manufacturers are prominent in biologic license application CRLs from the Center for Drug Evaluation and Research, some products move quickly to resubmission, like lebrikizumab and Astellas' zolbetuximab... Sub. Req'd

Glenmark Chief On ‘Big Shift' In Revenue By Region, Liraglutide India Outlook

(8/27, Anju Ghangrude, Generics Bulletin) ...Momentum in Europe may see the region's contribution to Glenmark's revenues become almost as big as the US business, currently dented by multiple challenges. The firm also outlines how things are poised in India for its biosimilar to Novo Nordisk's Victoza. Glenmark Pharmaceuticals Limited's revenue mix by region appears set for an overhaul, with Europe expected to match the US, a market where the Indian firm has been struggling to regain momentum... Global Sub. Full

Sagent Makes ‘Aggressive' Moves In A ‘Challenging' US Injectables Market

(8/27, David Wallace, Generics Bulletin) ...With Sagent Pharmaceuticals operating in an increasingly competitive US injectables market, the company has recently been making moves to bolster its position in the wake of its separation last year from its former parent company, Japan's Nichi Iko. Chief executive Vishy Chebrol talks to Generics Bulletin about the firm's strategic goals... Global Sub. Full

Regeneron Wins EU Approval for Lymphoma Bispecific Following FDA Rejection

(8/26, Lei Lei Wu, Endpoints News) ...It's Regeneron's first bispecific antibody approval in the world after it has faced a series of challenges in developing this type of cancer drug. The European Commission approved odronextamab for follicular lymphoma and diffuse large B cell lymphoma patients whose cancer had returned or progressed following two or more lines of prior therapy, the company announced Monday. The antibody treatment will be marketed as Ordspono... Full

Aurobindo, Glenmark, FDC Recall Products in US Market Over Manufacturing Issues: USFDA

(8/26, The Press Trust Of India) ...Drug makers Aurobindo Pharma, Glenmark and FDC are recalling products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA). Aurobindo Pharma USA Inc -- a unit of Hyderabad-based drug major -- is recalling 240 bottles of pain-relieving medication Healthy Living Acetaminophen, Aspirin and caffeine tablets... Full

Granules India Shares Fall After Surprise Inspection at a Key Facility: Exclusive

(8/27, Vivek Lyer and Hormaz Fatakia, CNBC TV 18) ...The inspection has been underway at Granules' facility at Gagilapur in Hyderabad since Monday, the sources added. The facility in question is used for the formulation and the Pharmaceutical Formulations Intermediates businesses and contributed to more than 70% of the overall revenue in the June quarter... Full

Waltz Health Debuts Specialty Pharmacy Platform, Partners with Reliance Rx to Slash Drug Costs

(8/26, Noah Tong, Fierce Healthcare) ...A new specialty pharmacy program by digital health company Waltz Health has been created to lower costs for payers and provide better experiences for patients and pharmacies. Waltz Health announced Waltz Connect, a platform that focuses exclusively on specialty drugs...Waltz Health supports 9 million patients and will track more than 80 million prescriptions this year. The company works with large insurers like UnitedHealthcare and Humana and alternative players like Mark Cuban's Cost Plus Drug Company. Park said large plans can expect to save 10% to 15% on specialty spend with Waltz Connect.'... Full

Omalizumab Biosimilar Equivalent to Reference Drug in Children With Severe Allergic Asthma

(8/26, Victoria Johnson, HCP Live) ...P043, anomalizumab biosimilar, was found to be equivalent to reference omalizumab in reducing exacerbations and managing asthma, with no significant differences in efficacy and safety parameters... Full

Weizmann Institute Researchers Reveal How Copaxone Protects the Heart Muscle and Improves its Function After a Heart Attack

(8/26, Weizman Institute Of Science) ...In the new study – led by Sarig and two research students from Tzahor's lab, physician Dr. Gal Aviel and Jacob Elkahal – researchers treated mice that had suffered heart attacks with a daily abdominal injection of Copaxone. Echocardiograms revealed that the drug improved the functioning of the damaged mouse hearts and that their heart chambers were sending more blood to the large arteries with each heartbeat, which in turn supplied more of the vital blood to other organs...People who suffer heart attacks do not always go to the emergency room right away, but the researchers discovered that Copaxone was effective in mice even when treatment began 24 to 48 hours after the heart attack... Full

Public Voices Often Ignored in States' Opioid Settlement Money Decisions

(8/27, Aneri Pattani and Henry Larweh and Ed Mahon, KFF Health News) ...The Philadelphia neighborhood is a critical center of the nation's opioid crisis, and the city had decided to spend $7.5 million in opioid settlement money to improve the quality of life there. But on that day, a Pennsylvania oversight board was about to vote on whether to reject the city's decision. It was a thorny issue with major implications — both for Kensington residents and people across the state, as the decision could set a precedent for what kind of spending the board would allow for years to come. But a lot of people were shut out of the discussion... Full

Senate Finance: Part B Inflation Rebates Have Saved Seniors $3 Billion

(8/26, Gabrielle Wanneh, InsideHealthPolicy) ...A new staff analysis from the Senate Finance Committee says the Inflation Reduction Act's price gouging penalty for drug makers that raise the price of Medicare Part D drugs faster than the rate of inflation has saved $3 billion for seniors and taxpayers since January 2023 and has generally slowed the rate at which companies are seeking to hike drug prices... Sub. Req'd

Pharmas' IRA Court Losses Mount. They Keep Pursuing Them.

(8/26, Amy Baxter, PharmaVoice) ...On the legal front, arguments have centered on the constitutionality of the IRA, with cases tackling the First, Fifth and Eighth amendments. With so many lawsuits across the country, pharma has pursued a strategy that could potentially land one of the cases in front of the Supreme Court. But judges have not been sympathetic to pharma, and all decisions rendered so far have rejected the lawsuits... Full

Dose of Reality: Big Pharma's Egregious GLP-1, Gene, and Cell Therapy Prices Projected to Increase Health Care Costs for Employers

(8/26, The Campaign for Sustainable Rx Pricing) ...According to new research from the Business Group on Health and professional services firm Aon, health care costs for employers are expected to increase next year driven by Big Pharma's egregious prices for blockbuster GLP-1 drugs and out-of-control prices on gene and cell therapy treatments. "GLP-1s and multimillion-dollar gene therapies," are the "major culprits," according to coverage of the analysis in Axios. Research firm Aon anticipates companies' health care costs will increase by nine percent next year. The Business Group on Health expects costs to increase by close to eight percent... Full

Column: The Weight-Loss Drug Revolution Exposes the Weakest Links in Our Healthcare System — Drug Pricing and Insurance

(8/27, Michael Hiltzik, Los Angeles Times) ...Unless the U.S. moves toward a single-payer healthcare system and starts to place limits on drug prices, it's the manufacturers of the weight-loss drugs that will reap most of the benefits. Sales of Wegovy and Ozempic made Novo Nordisk the most valuable European company last year and helped drive an increase in profits at Lilly for the second quarter ended June 30 by nearly 69% over the year-earlier period... Full

Insulin Lawsuits Obscure A Dirty Business

(8/26, Sally Pipes, Forbes) ...Dozens of state and local governments are suing drug companies and pharmacy benefit managers, alleging that they're unfairly hiking the price of insulin. The plaintiffs say they're fighting for patients. They're less forthcoming about the fact that they've profited handsomely from the system they're now decrying. For years, these cities and states have insisted on a cut—if not all—of the rebates that these pharmacy benefit managers extract from drug makers when negotiating over whether and how to cover specific drugs... Full

J&J's Move to Tweak 340B Policy for Stelara, Xarelto Denounced by HHS

(8/26, Zoey Becker, Fierce Pharma) ...Under J&J's new rebate model, eligible hospitals and healthcare organizations will have to seek rebates on the company's big-selling Stelara and Xarelto only after purchasing the drugs at commercial prices. Currently, the eligible providers get the 340B discounts at the time of purchase... Full

AHA: HRSA Tells J&J It Can't Replace 340B Discounts With New Rebate Approach

(8/26, Gabrielle Wanneh, InsideHealthPolicy) ...The Health Resources and Services Administration warned Johnson & Johnson on Friday (Aug. 23) it can't use rebates to replace upfront discounts for drugs it provides under the 340B discount program, according to the American Hospital Association, which had asked HRSA whether J&J's new 340B model for its popular blood clot treatment Xarelto and psoriasis and Crohn's treatment Stelara passed muster. Both drugs separately face lower Medicare Part D prices in 2026 as a result of the first round of price negotiation... Sub. Req'd

Uncertainty Looms Over Bulk Production Of Personalized GLP-1 Drugs

(8/26, Maaisha Osman, Jessica Karins, InsideHealthPolicy) ...Compounding pharmacies are facing ongoing uncertainty over whether they can produce personalized weight-loss drugs in bulk at FDA-registered 503b compounding facilities once the FDA-approved drug is no longer on the agency's drug shortage list, and FDA isn't providing clear answers. The question is a significant one for telehealth providers who are facing scrutiny for selling compounded versions of weight-loss drugs... Sub. Req'd

Facility Deficiencies Drive Rising CRL Rates For CDER Biologics

(8/26, Bridget Silverman, Pink Sheet) ...A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products... Sub. Req'd

BioRationality: FDA Opens Up Biosimilar Inquiries on Reddit

(8/26, Sarfaraz K. Niazi, PhD, The Center For Biosimilars) ...The FDA has opened a portal of inquiry that will be answered by Sarah Yim, MD, director of the FDA's Office of Therapeutic and Biologics and Biosimilars, on r/medicine at Reddit...Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum, where a representative will answer complex biosimilar questions, and encourages clearing misconceptions and advocating for updates to the Biologics Price Competition and Innovation Act guidelines... Full

Illinois Decries Renewed Lawsuit Over Generic Drug Pricing Law

(8/26, Celine Castronuovo, Bloomberg Law) ...The Association for Accessible Medicine's amended complaint rests on speculative injuries that don't resolve deficiencies a judge for the US District Court for the Northern District of Illinois identified when dismissing the case in June, Illinois Attorney General Kwame Raoul (D) wrote in his motion to dismiss filed Friday... Sub. Req'd

Wyden Say Legislation Has Prevented Pharmaceutical Price Gouging

(8/26, KATU) ...U.S. Sen. Ron Wyden, D-Oregon, on Monday touted the results of legislation he introduced to tackle pharmaceutical price gouging. The legislation was signed into law as part of the Inflation Reduction Act two years ago. It targets pharmaceutical companies who raise drug prices, including for cancer treatments, far above inflation rates... Full

Brazilian Medicines Regulator Consults On Regulatory Sandbox

(8/26, Francesca Bruce, Pink Sheet) ...In line with its 2024-2025 regulatory agenda, Brazil's drug regulator Anvisa is preparing to establish a regulatory sandbox to bring innovation to patients more quickly. The agency is consulting on a 247-page regulatory impact analysis report with a view to ensuring that the final sandbox model is effective. The sandbox would aim to address difficulties in regulating the development, manufacturing and commercialization of innovative products and services when the current regulatory framework hinders the evidence generation necessary for regulating these products... Sub. Req'd

After Canada's 2 Largest Railroads Shut Down, is the US Medical Supply Chain Affected?

(8/26, Paige Twenter, Becker's Hospital Review) ...Freight traffic on Canada's two largest rail networks suddenly stopped Aug. 22 after failed negotiations between the Teamsters labor union, which represents about 10,000 railroad employees, and Canadian National Railway and Canadian Pacific Kansas City. Work fully resumed Aug. 26 after the federal government stepped in. Teamsters said it will comply but plans to appeal the ruling. Peter Follows, CEO of Toronto-based consulting firm Carpedia, said one day of interrupted railway service can cause a week of backlog... Full

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