Friday, January 5, 2024

FTC/Industry Showdown Over Orange Book Patent Listings Could Come In 2024

(1/4, Brenda Sandburg, Pink Sheet) ...AstraZeneca PLC, Boehringer Ingelheim GmbH, and Teva Pharmaceuticals USA Inc. have rejected the FTC's claims and said they will not delist their patents. The two remaining companies, AbbVie Inc. and Viatris Inc., did not respond to queries about their plans..."Teva believes that patents identified by the FTC are properly listed in the Orange Book and stands behind the company's intellectual property. We value our relationship with the FDA and have informed the Agency of our position," Teva said... Sub. Req'd

Low Prices Are Contributing to America's Drug Shortage Problem

(1/5, Caitlin Owens, Axios) ...The challenging economics of domestic drug production don't only affect how our health system deals with unusually high levels of drug shortages — they also raise major national security implications, given U.S. dependency on foreign suppliers. But making more generic drugs at home would inevitably cost much more and require taxpayers, hospitals or patients themselves to pay more. Other commonly discussed options for easing shortages would also raise costs, albeit by not as much...Joe Grogan, who led Trump's Domestic Policy Council, argued that American consumers may be willing to pay more for a pharmaceutical supply based more at home... Full

Dong-A ST Completes BLA Filing with FDA for Stelara Biosimilar

(1/5, Lee Han-soo, Korea Biomedical Review) ...Dong-A ST said Accord Biopharma, a subsidiary of Intas Pharmaceutical, has received approval for the latter's biologics license application for DMB-3115, a biosimilar referencing Stelara (ingredient: ustekinumab) to the FDA...Under the accord, Dong-A ST and Meiji Seika Pharma will handle the research and development of DMB-3115 and exclusively supply the product to Intas, Accord Biopharma, and Accord Healthcare... Full

Akums Launches Generic Formulation to Treat Migraine

(1/5, Financial Express) ...Akums Drugs & Pharmaceuticals Ltd., a contract manufacturing pharmaceutical company, on Friday announced that it has launched the Lasmiditan tablet which is prescribed to treat migraine. This medication has received approvals from the Drug Controller General of India and the United States Food and Drug Administration. It is the generic formulation of Eli Lilly's REYVOW which is indicated for treatment of acute migraine... Full

USFDA Grants Tentative Approval to Lupin's Generic Formulation for Type 2 Diabetes

(1/5, Financial Express) ...Global pharma major Lupin Limited on Friday announced that it has received tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Dapagliflozin and Saxagliptin Tablets, 5 mg/5 mg and 10 mg/5 mg... Full

Biocon And Sandoz Join Hands On Japanese Humira Biosimilar

(1/4, Dean Rudge, Generics Bulletin) ...Sandoz is continuing to further its global biosimilar ambitions, striking a distribution agreement in Japan with Biocon for the Indian firm's adalimumab biosimilar, in one of Biocon's first major deals since completing the integration of Viatris's biosimilars business "in around 120 countries across advanced and emerging markets."... Global Sub. Full

A Three-Year Wait? Biocon Set To Weigh US Eylea Judgment

(1/4, Dean Rudge, Generics Bulletin) ...Biosimilar competition to Regeneron's blockbuster eye disease biologic Eylea (aflibercept) 2mg could be kept from the US market for a further three years following a mixed ruling for Biocon in closely watched litigation. Following a bench trial, US District Court for the Northern District of West Virginia judge Thomas Kleeh ruled that Regeneron demonstrated "by a preponderance of the evidence" that the Indian firm's proposed biosimilar infringes multiple claims of the originator's key US formulation patent 11,084,865, which is due to run its course in June 2027... Global Sub. Full

Amneal Launched Record Number of 39 New Retail and Injectable Products in 2023, Including 13 in Q4 2023

(1/4, Amneal Pharmaceuticals) ...In the fourth quarter of 2023, Amneal launched 13 new products, including 5 injectables. New injectable products added include potassium phosphate vials, tranexamic acid and esmolol intravenous bags. These launches provide a strong foundation for higher injectable revenues going forward. In addition, Amneal launched several key new retail products in the fourth quarter, including spironolactone suspension with 180-day exclusivity, valsartan and hydrochlorothiazide tablets, and icosapent capsules... Full

Lilly Makes Website to Simplify Access to Obesity Drug Zepbound, Plus Diabetes and Migraine Meds

(1/4, Nick Paul Taylor, Fierce Pharma) ...Eli Lilly has created a website to make it easier for patients to access medicines including its hot obesity drug Zepbound. The website, LillyDirect, combines telehealth and pharmacy services to provide access to Lilly's portfolio of diabetes, migraine and obesity medicines...Lilly has partnered with pharmacies and telehealth providers to deliver the services. Users who want to get telehealth for diabetes, migraine or obesity are respectively directed to 9amHealth, Cove and Form. Eversana and Truepill are already offering pharmacy services via LillyDirect and the drugmaker plans to add more service providers down the line... Full

Why Novartis Rebranded to Tell Patients, ‘We're With You'

(1/4, Eric Berger, MM+M) ...Pharmaceutical company Novartis rolled out new branding last month in the wake of its spin-off of generic drugs business Sandoz, showing off what it calls its status as a forward-looking medicine company. "We have moved from being a healthcare conglomerate to being entirely focused on innovative medicines," said Sreejit Mohan, Novartis global head of corporate brand strategy. "It's a historical moment for the company…and so we felt it was an opportunity to really rethink how we show up as Novartis in the healthcare ecosystem and in society more broadly."... Full

Walgreens Ready to Implement New Drug-Pricing Models

(1/4, Anna Wilde Mathews, The Wall Street Journal) ...Walgreens Boots Alliance is ready to implement new models for drug pricing, but will be flexible while pushing for setups that reimburse its pharmacies for services they provide, the company's new chief executive said Thursday on a call with analysts...Wentworth said Walgreens will work with healthcare payers on "any model that recognizes and reimburses pharmacies for the unmatched value we provide." He says Walgreens will focus on delivering services, including helping with patients' adherence to prescriptions, and getting paid for that... Sub. Req'd

I Went On a Mind-Boggling Journey to Get My Son's ADHD Medication Covered by Insurance — Twice

(1/5, Craig Idlebrook, STAT) ...I filled his prescription for the name-brand medication with my credit card, and started the process to appeal the insurance company's decision. What followed was a frustrating and costly process that took a couple of months and several dozen hours on hold to straighten out..This is a time-consuming, and often soul-crushing, process, and it is one that wastes countless productivity hours, if my experience is any indication. It's also profitable for insurers, as even the most dogged health care consumer may be able to recover only pennies on the dollar when a treatment or medicine is wrongfully denied...The only way to stop this cycle for individual consumers is for lawmakers to create regulations that unlock the black box of denials and ensure the insurers are being sensible and humane... Full

Part D In 2024: Premium Increases, Shrinking Choices Signal Early Impact Of IRA Redesign

(1/4, Cathy Kelly, Pink Sheet) ...Premiums for the 2024 standalone plans rose an average of 21% compared to the year before, according to a recent analysis by the Kaiser Family Foundation. For the three leading plan sponsors, Cigna Corp., Humana Inc. and Aetna Inc., premiums have gone up between 33% and 57%...Some analysts are pointing to the shifts in the market as evidence the IRA redesign will destabilize the Part D market in ways that hurt beneficiaries. "There are a lot of plans that are finding it's not going to be profitable for them to do this," former Trump Administration advisor Joe Grogan told the Pink Sheet... Sub. Req'd

Americans Pay the Most for Drugs Selected for Medicare Price Negotiation

(1/4, Denise Myshko, Managed Healthcare Executive) ...In February 2024, the Centers for Medicare and Medicaid Services will begin negotiations for the first 10 drugs selected under the 2022 Inflation Reduction Act. A new study finds that the list prices for the 10 selected drugs are about three times higher in the United States than in other countries. Even after rebates and discounts, prices are higher than other countries, with the exception of Janssen's Xarelto (rivaroxaban), according to recently released paper from the Commonwealth Fund. They found that Switzerland has the second-highest prices for most of the 10 drugs... Full

How Prices for the First 10 Drugs Up for U.S. Medicare Price Negotiations Compare Internationally

(1/4, Evan D. Gumas, Paige Huffman, Irene Papanicolas, Reginald D. Williams II, The Commonwealth Fund) ...Americans pay more for brand-name prescription medications than do residents of most other countries, with per capita spending on pharmaceuticals nearly three times the average of other member nations of the Organisation for Economic Co-operation and Development. In 2022, high costs forced one of five U.S. adults age 65 and older to skip or delay filling a prescription, miss or reduce doses, or use someone else's medication. More than half of patients resort to cost-coping strategies like coupons or free samples so they can get the medications they need but cannot afford.3 Such stopgap measures can have particularly serious consequences for older people who rely on medications to control chronic health conditions... Full

Blame Washington for Drug Shortages

(1/5, Merrill Matthews, RealClearHealth) ...In congressional hearings, some Washington lawmakers correctly identified the root cause of the problem -- namely, margins in the generic drug industry have dropped so low that many companies are pulling out. In May, Teva Pharmaceutical Industries, one of the world's largest makers of generic drugs, announced plans to shrink its generics business due to profitability concerns...Washington seems bound and determined to undermine the incentives that spur companies to develop and manufacture medicines -- not just generic ones, but novel treatments, too. Unless policymakers reverse course, patients can expect more trouble accessing lifesaving treatments... Full

Industry Groups Seek Changes to FDA's Remote Interactive Evaluation Guidance

(1/4, Joanne S. Eglovitch, Regulatory Focus) ...Trade groups representing the pharmaceutical and clinical research industries endorsed the US Food and Drug Administration's approach for conducting remote interactive evaluations as an alternative inspection tool but want more clarity on what FDA will provide at close-out meetings. Industry groups also want clarity on when the agency will request a RIE instead of conducting an on-site preapproval or prelicense inspection... Full

GOP Lawmakers Prod FDA Over Internal Scientific Disputes Resolution Process

(1/4, Ferdous Al-Faruque, Regulatory Focus) ...Congressional Republicans are seeking answers from the US Food and Drug Administration's about its internal scientific dispute resolution process. The investigation follows a recent Government Accountability Office report that raised concerns about political interference during the COVID-19 pandemic... Full

OK AG Announces Potential Legal Action Over Insulin Costs

(1/4, Kaylee Douglas, KFOR) ...As national lawmakers continue to debate legislation that would cap the price of insulin, Oklahoma Attorney General Gentner Drummond says he is exploring potential legal action against insulin manufacturers and pharmacy benefit managers over artificially increased prices for the diabetes medication... Full

N.Y. Seniors Now Have Out-Of-Pocket Cap On Prescriptions

(1/4, The Sun) ...On Jan. 3, [ U.S. Senate Majority Leader Charles E.] Schumer said this first-of-its-kind cap of an estimated $3,300 on prescription drug out-of-pocket costs in Medicare Part D will hold down costs for millions of New Yorkers. Schumer said this new Medicare drug cost capping will work in with other major healthcare provisions he secured including making vaccines free for seniors and a $35 insulin cap for those on Medicare, to help make healthcare more affordable for more than 3 million New York seniors... Full

Public Pharma's Biggest Barrier

(1/5, Audrey Stienon, The American Prospect) ...Several months ago, California's CalRx Biosimilar Insulin Initiative partnered with nonprofit generic drug producer Civica Rx to develop and manufacture insulin, a lifesaving drug for people with diabetes whose price has tripled in the last decade. The pair aim to sell their publicly backed brand across the country, including to people without insurance, at $30...Rather than showcasing the state's strength, the CalRx initiative is exposing how underwhelming the resources available to the government currently are. If states like California are serious about stepping into the ring with the corporate heavyweights of the pharmaceutical industry, they are going to need one hell of a workout... Full

Key Lobbying Effort Underway in India to Expedite Launch of New Drugs

(1/5, The Pharma Letter) ...Advocating for the implementation of parallel market authorization by the Central Drugs Standard Control Organization, the Organization of Pharmaceutical Producers of India is lobbying for a streamlined drug approval process in India. The OPPI represents multinational drugmakers such as Novartis, Sanofi, Merck & Co, Roche, and AstraZeneca. The organization has pointed out that launching new drugs in India can result in a four-year delay compared to the USA or the European Union, primarily due to complex clinical trial regulations... Sub. Req'd

Pharma Supply Chain: From Fragile to Agile

(1/4, Express Pharma) ...Sharmishtha Niyogi, Supply Chain Director at Merck, sheds light on the pivotal role of advanced technologies, strategic innovation, and resilient strategies in building, agile and resilient supply chains... Full

Switzerland Eases Parallel Importing & Allows Biosimilar Substitution

(1/4, Ian Schofield, Pink Sheet) ...New cost-containment rules making it easier and cheaper to parallel-import drugs into Switzerland took effect on January 1,, along with a new provision allowing pharmacists to decide whether to dispense a biosimilar medicine. The new rules on parallel imports, which are contained in an amendment to the Therapeutic Products Act, will "reduce the costs of parallel imports for marketing authorization holders without compromising patient safety," according to the Swiss medicines agency, Swissmedic... Sub. Req'd

Korea Review/Outlook: Biopharma Support Policies, Regulatory Innovation In The Spotlight

(1/4, Jung Won Shin, Pink Sheet) ...Authorities in South Korea have emphasized the continued importance of fostering the biopharma and other health-related sectors, after stepping up regulatory innovation in 2023 to help develop them into national flagship industries and to match standards of other major regulator agencies around the world...In a recent interview with the Pink Sheet, Minsoo Park, the ministry's second vice-minister, said the government intends to focus on promoting innovation-based development strategies as part of a strong wider strategy push to make Korea a bio-health powerhouse... Sub. Req'd

Canadian Cities, First Nations Oppose Purdue Opioid Settlement That Left Them Empty-Handed

(1/4, Soma Biswas, The Wall Street Journal) ...Review of Purdue Pharma's $6 billion opioid settlement could open the door for Canada's municipalities and indigenous First Nations—the only two groups not made up of individual claimants that have opposed the deal—to seek compensation they say has been denied them...The bankruptcy plan is being challenged by the U.S. Justice Department, which contests the lifetime immunity the settlement would grant Purdue's Sackler family owners from opioid-related lawsuits... Sub. Req'd

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