Thursday, February 8, 2024

Henlius Raises Stakes In Denosumab Race With Phase I Completion

(2/7, Adam Zamecnik, Generics Bulletin) ...Shanghai Henlius Biotech has completed a Phase I pharmacokinetics trial of its HLX14 biosimilar to Amgen's Prolia/Xgeva (denosumab), raising the stakes in a wider race towards the approval of denosumab biosimilars desired by several companies...Other companies have also set their sights on getting a denosumab biosimilar to gain a lucrative position on the global market...The German-based firm Fresenius Kabi is also edging towards a potential approval with its own denosumab biosimilar FKS517 as it completed a Phase III trial in August 2023. Beyond this, other companies developing denosumab biosimilars include Biocon, Celltrion, and Teva, among others... Global Sub. Full

Amgen Makes Progress with its Horizon Prize Tepezza, But There's Much Work Left to Do

(2/7, Kevin Dunleavy, Fierce Pharma) ...After Amgen completed its $27.8 billion buyout of Horizon Therapeutics in October, executives at the California biotech made it a priority to right the course of thyroid eye disease treatment Tepezza—an instant blockbuster which saw a perplexing slide in just its third full year on the market. Fourth-quarter sales of Tepezza show that Amgen is making progress but the company has lots of work ahead to get the drug back on its previous trajectory... Full

Zydus Lifesciences Gets USFDA Approvals for Dexamethasone Tablets

(2/8, Madhu Balaji, The Hindu Business Line) ...Zydus Lifesciences Ltd has received final approvals from the United States Food and Drug Administration to manufacture and market dexamethasone tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg and dexamethasone tablets USP, 2 mg... Full

Indian Drugmaker Lupin Beats Quarterly Profit Estimates On Strong Demand

(2/7, Manvi Pant and Kashish Tandon, Reuters) ...Indian generic drugmaker Lupin reported a bigger-than-expected rise in its third-quarter profit on Wednesday, helped by strong demand in its North American and domestic markets...Sales in North America grew nearly 24% during the quarter, boosted by strong demand for Lupin's generic version of Boehringer Ingelheim's Spiriva Handihaler, an inhaler used for bronchial asthma... Full

AstraZeneca Targets 2024 Growth as Portfolio Booms

(2/8, Eva Mathews, Reuters) ...AstraZeneca expects to boost revenue and profit this year on the back of resilient demand for its cancer and rare disease drugs, the company said on Thursday after reporting slightly lower than expected fourth-quarter profit... Full

Torrent Loses US Infringement Battle Over Supernus' Trokendi XR

(2/7, Urte Fultinaviciute, Generics Bulletin) ...While a US district court sided with Supernus over its patent infringement claims against Torrent, the court's opinion was sealed due to confidential and proprietary information. Supernus Pharmaceuticals is waving a victory flag after a US District Court in New Jersey ruled in its favor over Trokendi XR (topiramate extended-release) patent infringement claims against Torrent Pharmaceuticals... Global Sub. Full

Astrazeneca says Catalent Deal Shows Need for In-House Capacity

(2/8, Maggie Fick and Eva Mathews, Reuters) ...AstraZeneca, which is a client of Catalent for some of its drug manufacturing, is working to boost its in-house capacity to cut reliance on contract drugmakers, Chief Executive Pascal Soriot told reporters after the release of fourth-quarter results. "It really means for us that we need to be as independent as we can, in terms of our own supply", said Soriot, citing AstraZeneca's ongoing capital expenditures including its $300 million investment announced on Tuesday in a facility in Maryland for discovery and development of cell therapies... Full

Lilly CEO Raises Concerns About Novo-Catalent Buy, Calling the Novo Nordisk Deal ‘Unusual'

(2/7, Anna Brown, Endpoints News) ...Eli Lilly has expressed reservations about the Novo-Catalent deal and its potential impact on the wider manufacturing industry. "Given the nature of this transaction — a vertical integration where the client list of Catalent might number in excess of 100 entities, all of which plan to compete in some way with Novo Nordisk — it sets up for an interesting inquiry by everybody [including] politicians," CEO David Ricks said in an interview with the Financial Times... Full

Catalent Receives Another Regulatory Wrist Slap at Indiana Plant Included in Novo Buyout

(2/7, Fraiser Kansteiner, Fierce Pharma) ...As part of the acquisition of manufacturing giant Catalent, Novo Nordisk will fork over $11 billion for three of the CDMO's plants. But one of those facilities has now been flagged for control lapses. During an inspection of Catalent's Bloomington, Indiana, factory last fall, FDA investigators uncovered quality control lapses—and even found a "pest" on the manufacturing line...Catalent's Bloomington plant has drawn FDA ire in the past. Last summer, for instance, Regeneron's high-dose Eylea received a surprising FDA snub that was linked to cleaning and procedural issues at the Indiana plant... Full

Eli Lilly, Minnesota Reach Settlement in Insulin Price Case

(2/7, Celine Castronuovo, Bloomberg Law) ...Eli Lilly & Co. has agreed to offer its insulin products at no more than $35 per month to any Minnesota resident with a valid prescription, according to the terms of a proposed settlement filed Wednesday in a case over insulin pricing dating back to 2018. The settlement, filed in the US District Court for the District of New Jersey, would hold Lilly to this cost for Minnesotans for five years after the agreement goes into effect... Full

Long-Term Biosimilar Sustainability Is At A Tipping Point, Report Says

(2/8, Urte Fultinaviciute, Generics Bulletin) ...While biosimilar medicines have offered a great deal of savings for US healthcare, the current system may negatively affect the long-term sustainability of the sector, potentially leading to a decrease in biosimilar developers and monopolization of the market, suggests a new IQVIA report..."Given the desired aim of creating a system that makes space for biosimilars to enter and sustain in the market leading to lower costs and overall savings, the dynamics of the current reimbursement system needs to be examined," the report suggests... Global Sub. Full

Blue Shield Of California's Pharmacy Benefit Overhaul Could Still See Boost From Transparency Legislation

(2/7, M. Nielsen Hobbs, Pink Sheet) ...The payor's multiyear plan to ditch the traditional PBM model and use multiple vendors has drawn a lot of skepticism from other actors in the health care system, but Blue Shield is hoping that it can help give policymakers some momentum, VP Lum tells the Pink Sheet. Blue Shield of California's plan to replace its traditional pharmacy benefit arrangement with what it hopes will be a more transparent assemblage of services won't go into full effect until 2025, but it has already generated a lot of hope and criticism across the healthcare landscape... Sub. Req'd

1 in 5 Most Costly Generics Not Available Through National Direct-to-Consumer Pharmacies

(2/7, Hayden E. Klein, AJMC) ...A new analysis revealed that 1 in 5 of the most expensive generic drugs was not available at any of the 5 national direct-to-consumer pharmacies in 2020: Amazon, Walmart, Costco, Health Warehouse, and the Mark Cuban Cost Plus Drugs Company..."Differences in the availability and costs of generic prescription drugs sold by direct-to-consumer pharmacies provide a glimpse into the challenges patients may face trying to find inexpensive options for their essential medicines," the researchers said... Full

W&M Chair Eyes Reimbursement Tweaks, Tax, Trade Policies To Stem Drug Shortages

(2/7, Maaisha Osman, InsideHealthPolicy) ...House Ways & Means Chair Jason Smith (R-MO) urges bipartisan action to tackle drug shortages, suggesting lawmakers weigh solutions that include revisions to Medicare reimbursement, long-term contracts with manufacturers, state-funded buffer supplies of drugs, and trade and tax policies that incentivize domestic drug production... Sub. Req'd

Environmental Regulations May Create Barriers To Onshoring More Rx Manufacturing

(2/7, Sarah Karlin-Smith, Pink Sheet) ...The February 6, House Ways and Means Committee hearing on drug shortages spent ample time discussing how the US could use legislative levers, such as the tax code, to encourage onshoring and reduce its dependence on foreign manufacturers, particularly India and China. The idea is a popular solution on both sides of the political aisle. But some Republicans questioned whether the Environmental Protection Agency might pose a barrier... Sub. Req'd

Generic Makers: Economics, Not Foreign Production, Causing Drug Shortages

(2/7, Jessica Karins, InsideHealthPolicy) ...At the Association for Accessible Medicines (AAM) annual meeting in Tampa, FL this week, officials with the generics and biosimilars lobbying group told Inside Health Policy lawmakers hoping to address drug shortages should focus on ensuring a competitive generics market, not onshoring...During an AAM panel featuring generics industry leaders, speakers agreed the major factor driving shortages of generic drugs is economics, not foreign manufacturers. Arunesh Verma, president of Indian pharmaceutical company Cipla's North American branch, said U.S. lawmakers are misdiagnosing the problems leading to shortages when they focus on manufacturing issues in India and China... Sub. Req'd

Foreign Suppliers Add Pressure to US Pharmaceutical Supply Shortages: Lawmakers

(2/7, Clayton Vickers, The Hill) ...In a hearing called to examine U.S. chronic drug shortages, lawmakers expressed concern over a recent report that found more than 80 percent of pharmaceutical active ingredients are imported into the U.S. from foreign manufacturers, primarily China and India...Jeromie Ballreich, associate professor at Johns Hopkins Bloomberg School of Public Health, along with several other witnesses, recommended Congress provide monetary incentives for pharmaceutical manufacturers to return to the U.S., enter longer-term production contracts, keep larger stores of medicines and contribute to a government stockpile that would hedge against uncertainty... Full

Six Key Moments from Hearing On Chronic Drug Shortages

(2/7, United States House Committee on Ways & Means) ...Over 250 medications are currently in short supply, covering everything from asthma and blood clots to treatments for multiple kinds of cancers. At the same time, America is too dependent on foreign countries for ingredients and medical supplies, warned witnesses at a Tuesday Ways and Means Committee hearing on the drug shortage crisis...Many Americans cannot live without access to a certain medication, which may be made abroad or made with key ingredients procured from abroad. Ways and Means Committee Chairman Jason Smith (MO-08) highlighted how our nation's reliance on foreign nations for drugs could have serious consequences for patients should a hostile power choose to stop exporting drugs or drug ingredients to the United States... Full

Backlash Builds Over Biden Plan for Seizing Drug Patents

(2/8, Ian Lopez, Bloomberg Law) ...The pharmaceutical industry, Trump and Obama administration officials, and others are urging the Biden administration to reconsider a controversial plan for seizing patents on a drug when its cost gets too high, claiming the approach misinterprets decades-old law and threatens the delicate pipeline that produces innovative, life-saving drugs... Sub. Req'd

Bernie Sanders On What Americans Need to Understand About Big Pharma

(2/7, Anna Gordon, Time) ...Pharmaceutical Research and Manufacturers of America spokesperson Sarah Ryan says Sanders is engaging in a "shaming exercise." "A small number of senators are focused on a political shaming exercise instead of what will help lower what Americans pay for medicines at the pharmacy. The United States is the only country that allows middlemen to profiteer on medicines, leading to higher costs for patients," Ryan said in a statement. TIME spoke to Sanders on Feb. 7 ahead of the hearing about what Congress can do to lower drug prices, what Americans don't understand about Big Pharma's business model, and why the Biden Administration should be doing more... Full

Pharma CEOs to Blame High Costs On Middlemen in Senate Hearing

(2/8, Jalen Brown and Nyah Phengsitthy, Bloomberg Law) ...Leading pharmaceutical executives are ready to pin the blame for high drug costs on pharmacy benefit managers, setting up a potential showdown with Sen. Bernie Sanders, who's demanding price reductions...Robert Davis, CEO of Merck, is planning to make a case at Sanders' hearing against insurance plans keeping the discounts provided by Merck and other manufacturers, advocating instead for these savings to lower patients' out-of-pocket costs directly... Sub. Req'd

Under Bernie Sanders's Glare, Pharmaceutical Chiefs Will Testify On Drug Prices

(2/8, Noah Weiland and Rebecca Robbins, The New York Times) ...Two of the pharmaceutical executives, Mr. Duato of Johnson & Johnson and Mr. Davis of Merck, agreed to testify after being threatened with subpoenas. Mr. Sanders had planned to hold a committee vote last week on whether to issue them, but the executives agreed to appear at the hearing before such a vote was taken... Sub. Req'd

New Hearing, Same Blame Game: Pharma, PBMs Trade Accusations Ahead of Senate Session

(2/7, Nicole DeFeudis, Endpoints News) ...A day before the Senate's Health, Education, Labor, and Pensions Committee meets to discuss the high cost of prescription drugs in America, the pharma industry and pharmacy benefit managers are once again pointing fingers...Merck's Davis is expected to say that "a lifesaving drug is not effective if the patient who needs that drug cannot afford it," according to testimony released before the hearing. But he will argue that the problem is insurers and the PBMs who negotiate drug prices on their behalf, but don't pass enough savings on to patients, according to the testimony... Full

As Medicare Drug Pricing Negotiations Begin, AstraZeneca Stays Mum On Government's Offer

(2/8, Andrew Joseph, STAT Plus) ...Last week, Medicare made its first offers to the makers of the 10 products subject to negotiation, though it said it would be up to the companies to discuss the proposals. On Thursday, at a press briefing at which they presented their 2023 earnings, AstraZeneca executives also played coy about the bargaining over the price of the company's diabetes drug Farxiga. "We have received the first offer, but as you can imagine, we will not disclose what the offer is," Ruud Dobber, the company's executive vice president of biopharmaceuticals business, said at the event, held at the London Stock Exchange. "We are in active negotiation, and it will be a few rounds of discussions" with Medicare... Sub. Req'd

House Committee Advances Another PBM Reform Bill That Would Ban Spread Pricing

(2/7, Lia DeGroot, Endpoints News) ...The House Committee on Oversight and Accountability on Tuesday advanced legislation that would ban some common practices of pharmacy benefit managers - the middlemen who negotiate drug prices on behalf of insurers. The bill, called the Delinking Revenue from Unfair Gouging Act, would require certain PBMs that contract with a carrier offering federal health benefits plans to "de-link" the fees they charge insurers from the price of drugs... Full

Biopharma, US FTC Portray Opposing Sides In Debate Over Patent ‘March-In' Policy

(2/7, Brenda Sandburg, Pink Sheet) ...BIO and PhRMA describe the complexity of pricing biopharmaceuticals in arguing price should not be a factor in deciding whether to exercise march-in rights. The FTC suggests agencies consider a patent holder's private investment and breadth of patent coverage, while KEI, AUTM, the American Bar Association, and former USPTO directors also weigh in on NIST's proposed framework... Sub. Req'd

The Generic Industry Faces External Challenges

(2/7, Bob Pollock, Lachman Consultants) ...At yesterday's AAM annual meeting, David Gaugh, AAM's interim President and CEO, discussed the unprecedented events that threaten the sustainability of today's generic drug and biosimilar industry. In his keynote address, he addressed how the generic drug and biosimilar industry is being stressed by economic issues, PBMs, government programs, and other events out of its control... Full

Latest CMS Data Reveal the Truth About U.S. Drug Spending

(2/7, Adam J. Fein, Ph.D., Drug Channels) ...The boffins at the Centers for Medicare & Medicaid Services recently dropped the latest National Health Expenditure data, which measures all U.S. spending on healthcare. As you will see, retail and mail prescription drug spending remain a consistently small share of the $4.5 trillion that we spend on U.S. healthcare. And contrary to what you might read, drug spending growth was *not* driven by purportedly "skyrocketing" drug prices. In reality, nearly all drug spending growth occurred due to growth in the number of people treated, prescriptions dispensed, and other nonprice factors... Full

Alarming Pharmacy Closures in Kansas Illustrate Need for Urgent PBM Reform

(2/8, Steve Dreher, The Topela Capital-Journal) ...In Kansas, the consequences of spread pricing have been particularly severe, contributing to the financial strain faced by many rural pharmacies. As a result, pharmacies are finding it increasingly challenging to maintain operations, stock vital medications and worse, stay open...PBM reform is not merely an option - it's an imperative to safeguard patient access to care in rural areas of the state... Full

Maryland's Drug Affordability Board May Expand to Lower Prices if it Gets the Votes

(2/7, Scott Maucione, WYPR) ...The state's Prescription Drug Affordability Board was created and 2019 and has the ability to set upper payment limits on drugs for state and local government health plans. However, a new piece of legislation would expand the board's jurisdiction to set those limits for all plans in Maryland. The limits are a solid monetary topline that insurers in the state will not pay more than for a specific drug. The legislation would also appropriate $1 million to the board in 2025 to continue its work. Top officials in Maryland like Baltimore Mayor Brandon Scott, Baltimore County Executive Johnny Olsewski, medical experts and faith leaders also testified in favor of the bill Wednesday before the Senate Finance Committee... Full

Mich. Counties Sue Drug Firms Over Insulin

(2/8, Christina Hall, The Detroit Free Press) ...Four metro Detroit counties filed federal lawsuits Wednesday against some of the nation's biggest pharmaceutical manufacturers and pharmacy benefit managers alleging illegal price fixing for insulin products. Macomb, Monroe, Wayne and Washtenaw counties filed the lawsuits in U.S. District Court in New Jersey against more than a dozen companies, including Lilly, Sanofi Aventis, Novo Nordisk, Express Scripts, Optum Rx and CVS Caremark, per their attorneys... Full

FDA and EMA Launch Parallel Scientific Advice Pilot Program for Complex Generics

(2/7, Sarah Ibrahim, PhD, U.S. Food & Drug Administration) ...CDER's Office of Generic Drugs and the European Medicines Agency launched a voluntary pilot program to facilitate concurrent discussions between generic drug applicants and the two regulatory bodies, with the ultimate goal of improving patient access to harder to develop generic drugs. This pilot program is an expansion of FDA and EMA's existing Parallel Scientific Advice program and focuses on complex generics/"hybrid medicinesExternal Link Disclaimer" (an EMA term for medications that loosely corresponds to complex generics)... Full

EMA Seeks to Ease the Regulatory Burden On Biosimilar Developers, Following Push by FDA

(2/7, Zachary Brennan, Endpoints News) ...The European Medicines Agency earlier this week proposed reducing the regulatory requirements for biosimilar developers due to what it calls "the advances in the analytical sciences and the extensive regulatory experience gained." Moving forward, the EMA says it's reevaluating whether all biosimilar applications will need to include in vivo non-clinical data, as well as other clinical efficacy and safety data... Full

France Takes Action As Drug Shortages Soar

(2/7, Ian Schofield, Pink Sheet) ...All product classes are affected by supply chain issues, with drugs for the cardiovascular and nervous systems, anti-infectives and anticancer drugs particularly at risk, says the French regulator. With the upward trend in drug shortages showing no signs of abating, the French medicines agency, ANSM, says it took a number of steps to contain the problem last year, such as setting product quotas and allowing imports of medicines in short supply... Sub. Req'd

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