Wednesday, April 17, 2024

Alvotech, Teva Get FDA Approval for Stelara Biosimilar Psoriasis Treatment

(4/16, Adam L. Cataldo, Dow Jones) ...Alvotech and Teva Pharmaceuticals said the Food and Drug Administration approved the Selarsdi injection for subcutaneous use as a biosimilar to Stelara for the treatment of psoriasis...Selarsdi is expected to be marketed in the U.S. on or after Feb. 21, 2025, following a settlement agreement with Stelara's manufacturer Johnson & Johnson, the companies said Tuesday... Full

Alvotech's Stelara Biosimilar, Selarsdi, Receives FDA Approval

(4/16, Skylar Jeremias, The Center For Biosimilars) ..."The approval of Selarsdi—which is our second biosimilar approval this year—underscores Teva's commitment to expanding the availability, access and uptake of this important treatment option to patients in the U.S.," Thomas Rainey, senior vice president, U.S. Market Access at Teva, said in a statement. "The biosimilars market is growing, both globally and in the U.S., and biosimilars are a key component of delivering on Teva's Pivot to Growth strategy. The partnership model that we've established enables us to leverage our commercial presence and experiences globally as we move to bring additional biosimilars to market."... Full

FDA Approves Biosimilar Ustekinumab-aekn for PsO, PsA

(4/16, Lana Pine, HCPLive) ...Alvotech and Teva announced the US Food and Drug Administration (FDA) approval of its ustekinumab (Stelara) biosimilar, ustekinumab-aekn (Selardsi), for the treatment of moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in both adults and pediatric patients aged = 6 years...The companies, both of whom anticipated market entry in Canada in Q1 2024, have already been granted regulatory approval in Japan, Canada, and in the European Economic Area... Full

Teva Joins World's Top 20 Pharmaceutical Companies

(4/16, Judy Siegel-Itzkovich, The Jerusalem Post) ...After years of financial problems, downsizing, and dismissals, Israel's multinational Teva Pharmaceutical Industries Ltd. has been named No. 19 among the top 20 best-earning pharmaceutical companies in the world...Teva said it expects to continue the revenue upturn in 2024, though only by a small amount. It said it would continue the divestment of some companies, including a plan to part with the small-molecule active pharmaceutical ingredients business, which includes a portfolio of 350 products, serves more than 1,000 customers, and employs 4,300 workers... Full

10 of 20 Most Popular Drugs Are in Shortage

(4/16, Paige Twenter, Becker's Hospital Review) ...In the first quarter of 2024, the U.S. hit a 23-year record after logging 323 active drug shortages. And among GoodRx's list of the nation's 20 most popular therapies, half are in shortage...Prednisone: Thirty-seven solutions are available and two from Teva Pharmaceuticals are on back order, the ASHP reported. The therapy is used for eczema and psoriasis. Tramadol: Teva is reporting a short-term shortage of one solution of the painkiller, according to the ASHP. Seven other presentations are at normal supply levels... Full

Healthy Returns: U.S. Drug Shortages Reach Record High, Hitting Wegovy, ADHD Medications

(4/16, Annika Kim Constantino and Ashley Capoot, CNBC) ..."All drug classes are vulnerable to shortages," Paul Abramowitz, CEO of the American Society of Health-System Pharmacists, or ASHP, wrote in a blog post on Thursday. But he said "some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas." Ongoing scarcity of ADHD medications "also remain a serious challenge for clinicians and patients," Abramowitz added... Full

AbbVie Inks Deal for Medincell's Long-Acting Injectable Platform Worth Up to $1.9B

(4/16, Nicole DeFeudis, Endpoints News) ...The deal gives Medincell $35 million upfront and up to $1.9 billion in milestones for the development of up to six therapeutic long-acting products...Medincell touted the recent approval of Teva's Uzedy, the first product using its technology, last April. Uzedy is an injectable formulation of the schizophrenia drug risperidone dosed in one- or two-month intervals. "We have shown that our technology could be approved by the FDA. Our business development has been accelerating," Medincell CEO Christophe Douat told Endpoints News in an interview... Full

Boehringer Ingelheim Touts 10-Year Plan As it Eyes Overtaking Bayer As Germany's Largest Pharma

(4/16, Ayisha Sharma and Anna Brown, Endpoints News) ...Driven in part by the blockbuster success of its diabetes and heart drug Jardiance, Boehringer may have surpassed Bayer to become the biggest German drugmaker, according to media comments on the call. Below, Endpoints News highlights eight key takeaways from the media event... Full

Sandoz's Humira Biosimilar Nabs Significant Market Share Thanks to CVS Partnership

(4/16, Zachary Brennan, Endpoints News) ...According to an investor note from Evercore ISI on Monday, CVS on April 1 removed brand-name Humira from its major national formularies, which cover about 30 million people, and exclusively covered Hyrimoz. "One week after the formulary changes, we have seen an explosion of Hyrimoz new scripts," Evercore's Elizabeth Anderson wrote in the note...What makes this situation unique is that CVS has not selected the cheapest product, so it's "propping up a more inflated version than what the marketplace is otherwise bearing," Antonio Ciaccia, president of 3 Axis Advisors and consultant to Mark Cuban Cost Plus Drugs, told Endpoints News... Full

FDA Hits Natco with Warning Letter Over India Facility, Suspends Product Shipments to US

(4/16, Lia DeGroot, Endpoints News) ...Manufacturer Natco Pharma was hit with a warning letter earlier this month over violations at its facility in the Indian state of Telangana, following an insufficient response to an FDA Form 483 last fall. Until the drugmaker shows how it fixed the issues in the warning letter, Natco has suspended making products at the facility for the US, the agency said... Full

FDA Slams 3 Indian Drugmakers in Flurry of Recent Form 483s

(4/16, Joseph Keenan, Fierce Pharma) ...The FDA slammed three Indian drugmakers with Form 483s following recent inspections that uncovered unsanitary conditions, broken equipment and poor recordkeeping. Mumbai-based Alkem Labs was cited with 10 observations in the wake of a March inspection of its facility in Baddi, India. Under the first observation, inspectors said the company didn't review unexplained discrepancies and the failure of a batch or of its components nor investigate whether the batch had been distributed to customers... Full

Pharmacies Aren't to Blame for the Opioid Crisis

(4/16, Roger D. Klein, RealClearPolicy) ...Excessive blame for opioid overdose deaths has been placed on prescription medicine suppliers generally. These deaths are mostly attributable to illegally imported Chinese fentanyl, which enters the United States via our porous southern border. Consequently, opioid deaths have increased despite tighter prescribing habits in response to heightened physician monitoring and enforcement, cultural change, and lowered manufacturers' production quotas...The opioid addiction crisis has evolved from its roots in over-prescription of narcotics into an exceptionally deadly multi-faceted societal ill involving drugs trafficked from China and Mexico and ineffective policy responses. Public health would be better served by addressing these areas, rather than by filing dubious and potentially counterproductive lawsuits against drugstores... Full

Medicare-Negotiated Drugs May Not Get Favorable Coverage In Part D: Will CMS Intervene?

(4/16, Cathy Kelly, Pink Sheet) ...Insurance plans put on notice that CMS is concerned about restrictions on drugs with negotiated prices, but it's not clear what the agency can or will do about it...The realization is more dreary news for products that end up in the crosshairs of the Inflation Reduction Act pricing process, even though the law requires Part D plans to cover negotiated drugs. There is no requirement that plans put those products on a preferred formulary tier, nor are there limits on utilization management tools like prior authorization or step therapy that plans can impose... Sub. Req'd

Senators Demand Answers from Drugmaker About Discontinuation of Popular Insulin Levemir

(4/16, Ken Alltucker, USA Today) ...In a letter Tuesday to Novo Nordisk's top executives, Sens. Jeanne Shaheen, D-N.H., Raphael Warnock, D-Ga., and Elizabeth Warren, D-Mass., said the company's decision to discontinue Levemir, a long-acting insulin, "failed to take into consideration patient access to affordable, long-acting insulin substitutes."...Novo Nordisk previously told USA TODAY it would discontinue U.S. sales of Levemir due to global manufacturing constraints and the availability of other forms of insulin. The company also blamed pharmacy managers and insurers who limited access to Levemir on drug formularies, the list of drugs insurers cover for patients... Full

ICER Requests Public Input To Identify Drugs For Price Hike Report

(4/16, Gabrielle Wanneh, InsideHealthPolicy) ...The Institute for Clinical and Economic Review has released the official procedures for conducting its sixth assessment of major drugs that experienced substantial price increases without adequate evidence to justify the increases. The drug pricing watchdog will identify 10 drugs with net price hikes that have generated the largest increase in drug spending at the federal level and is seeking public input for an additional three drugs that have experienced similar price increases over the same timeframe but won't make ICER's final list... Sub. Req'd

Thune To AHA: Lame Duck Package Could Reform PBMs, 340B & Doc Pay; Extend Telehealth

(4/16, Dorothy Mills-Gregg, InsideHealthPolicy) ...Senate Republican Whip John Thune (SD) told hospitals to expect that Congress will include several health care policies in a legislative package during the post-election lame duck session, likely containing provisions that address physician payments, reform pharmacy benefit managers and extend telehealth flexibilities... Sub. Req'd

U.S. Probes High Generic Drug Prices

(4/16, Jennifer Calfas, The Wall Street Journal) ...The Department of Health and Human Services' Office of Inspector General said it is examining whether health insurers' shared ownership of pharmacy-benefit managers and pharmacies has played a role in high drug prices. "We will determine the impact of related entity transactions within select vertically integrated entities on the prices for covered Part D drugs," the OIG said in an undated post on its website... Sub. Req'd

Explainer: Why are US Pharmacy Benefit Managers Under Fire?

(4/16, Ahmed Aboulenein, Reuters) ...Pharmacy benefit managers are in the crosshairs of Republicans and Democrats in Congress but have so far dodged any new litigation or reforms that had been targeted for inclusion in last month's U.S. government budget deal. Many lawmakers, drugmakers and government officials have pointed a finger at these industry middle men, suggesting they play a critical role in high prescription drug costs in the United States... Full

PBMs Should Be Health Plan Fiduciaries, Employers Tell Congress

(4/16, Sara Hansard, Bloomberg Law) ...Pharmacy benefit managers should be required to act as fiduciaries acting in the interest of health-plan beneficiaries in providing benefits and paying plan expenses, a House subcommittee was told at a Tuesday hearing. Three PBMs—CVS Health, Optum RX, and Express Scripts—"have taken over the market share" for self-insured health plans, controlling the prescription drugs that are covered on health plan formularies and price rebates on those drugs, said Russell DuBose, vice president of human resources for Tuscaloosa, Ala.-based manufacturer Phifer Inc... Sub. Req'd

Understanding "Delinking" in the PBM Legislation | AMCP 2024

(4/16, Peter Wehrwein, Managed Healthcare Executive) ...Ross Margulies, J.D., M.P.H., a partner in the Foley Hoag law firm, spoke about the PBMs and the PBM legislation today at the 2024 annual meeting of the Academy of Managed Care Pharmacy, which is being held at the Ernest N. Morial Convention Center in New Orleans. In an interview with Managed Healthcare Executive prior to the meeting, Margulies discussed the proposals to "delink" PBM compensation from drug prices. Currently, rebates that are tied to a prescription drug's list price are a major source of revenues of PBMs and a target of the criticism directed at the industry... Full

Health Plans Wary of Biosimilars Despite Potential for Lower Costs | 2024 AMCP

(4/16, Logan Lutton, Managed Healthcare Executive) ...The biggest contributing factor leading to a biosimilar restriction is that a PBM has already contracted for a reference product (36%), followed by a reference product being restricted by the plan (32%), according to the survey. "Many payers will adopt the PBM formulary for the simple reason that they don't feel they can make a better deal than the PBM and make up the lost rebate revenue they receive," co-author Dan Danielson, M.S., said in an email interview. "The PBMs have a lot of sway in the market."... Full

Seniors Pay More for Generic Medicines Every Year While Prices Continue to Fall. Why?

(4/16, Michael Sargent, AAM) ...Despite years of demonstrated savings and price deflation, the Medicare program has allowed Medicare drug plans to make changes over the last 10 years that require patients to pay more for many generic drugs even as the prices of those drugs have fallen. It is critical that Congress and the administration address PBM coverage and tiering and practices that increase patient costs for lower-cost medicines. Simple formulary reforms that place generic drugs on existing generic tiers can level the playing field by prioritizing coverage decisions and by nudging Medicare plans and PBMs towards patient-centric choices... Full

New Study Finds Insurers and PBMs Increasing Access Restrictions in Medicare Part D

(4/16, Nicole Longo, PhRMA) ...Medicare beneficiaries are facing greater access restrictions on their lifesaving medicines, according to a study by the Schaeffer Center at the University of Southern California recently published in Health Affairs. Looking at the Medicare Part D prescription drug benefit program, researchers found that health plans and pharmacy benefit managers are imposing more utilization management restrictions on prescription medicines or excluding the medicines from their formularies altogether... Full

The Top 15 Specialty Pharmacies of 2023: Market Shares and Revenues at the Biggest PBMs, Health Plans, and Independents

(4/16, Adam J. Fein, Ph.D., Drug Channels) ...Drug Channels Institute's latest analysis finds that participants in the specialty pharmacy market continue to get more diverse-although revenues remain highly concentrated...For 2023, DCI estimates that U.S. prescription dispensing revenues from specialty pharmaceuticals reached $243 billion. Specialty drugs accounted for nearly 40% of the pharmacy industry's prescription revenues (but a higher share of payers' net spending)... Full

5 Takeaways From U.S. News' ‘Solving the Crisis of Critical Drug Shortages' Event

(4/16, Brianna Navarre, U.S. News) ...While news of individual drug shortages routinely make headlines, those are often just the tip of the iceberg. Today, with more than 300 drugs currently in constrained supply, shortages have reached an all-time high, according to data from the ASHP, the American Society of Health-System Pharmacists...A panel of experts recently discussed how health care systems and providers might navigate – and potentially eliminate – drug shortages in the short and long term during a recent virtual event hosted by U.S. News & World Report. Here are five takeaways from that conversation... Full

The Fourth Circuit Upholds CMS' Definition of "Line-Extension Drug" and "New Formulation"

(4/17, Sophia R. Gaulkin, FDA Law Blog) ...On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency's definitions of "line-extension drug" and "new formulation" for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP). Vanda Pharmaceuticals, Inc. v. Centers for Medicare and Medicaid Servs., No. 23-1457 (4th Cir. Apr. 10, 2024)... Full

FDA Officials Offer Advice On Smooth BE Studies, Comparative Analyses for Combo Products

(4/16, Joanne S. Eglovitch, Regulatory Focus) ...To avoid clinical holds associated with bioequivalence (BE) and bioavailability (BA) studies for investigational new drug applications (BIO-INDs) for generic drugs, sponsors should follow recommendations in the Food and Drug Administration's (FDA) product -specifics guidances (PSGs) and closely adhere to the reference listed drug (RLD) labeling, according to Andrea Dugas, a physician with the Division of Clinical Safety and Surveillance in the Office of Generic Drugs (OGD), who spoke at the April 11, Generic Drugs Forum... Full

Bill to Protect Access to Discounted Drugs for Low-Income Marylanders Headed to Governor

(4/16, Danielle J. Brown, Maryland Matters) ...In the hectic last days of the legislative session, it can be challenging to predict which bills will be successful and go on to become law, and which ones will get lost in the legislative shuffle. One bill that got a boost of momentum right before the end of the 2024 legislative session is House Bill 1056, which tries to keep lower price prescription drugs accessible to lower income Marylanders across the state... Full

National Drug Stockpiles Create ‘False Sense Of Security'

(4/16, Ian Schofield, Pink Sheet) ...The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring "significant risks" for the supply chain and access to medicines...These include extra costs and complexity for manufacturers, and problems in reallocating stock from one country to another to mitigate shortages because stockpiles can only be used in that national market, Medicines for Europe says in a April 15, position paper... Sub. Req'd

Essential for Better Health, Why Ignore the Value of Generic Medicines?

(4/17, Arnaud Mahéas, Euractiv) ...Medicines for Europe together with IQVIA has published a report "Beneath the Surface: Unravelling the True Value of Generic Medicines" which demonstrates the pivotal role of generic medicines in enhancing access, ensuring financial sustainability, bolstering supply chain resilience, and improving patient outcomes...Considering this data, it is evident how our sector plays a pivotal role in bolstering healthcare systems and providing European patients with access to life-saving medicines. However, the sustainability of the system is under threat due to downward looking pricing policies and supply chain challenges... Full

Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?

(4/16, Derrick Gingery, Pink Sheet) ...As US and European regulators look to boost interest and participation in the parallel scientific advice program for complex generics, a fee that sponsors don't want to pay could be hindering participation just as some may not be aware of the program at all. The program allows sponsors to meet with US Food and Drug Administration and European Medicines Agency officials to gain alignment on scientific and development questions. Ideally, the meetings would streamline application filing and approval in both jurisdictions. So far, only two requests have been made to use the program and completed the process, much to the chagrin of both regulators... Sub. Req'd

‘Unbalanced' EU HTA Timelines Exacerbated By Rare Disease & Cancer Drugs

(4/16, Eliza Slawther, Pink Sheet) ...As it stands, drugmakers will have just 90 days to prepare their dossiers for EU-wide joint clinical assessments under the new Health Technology Assessment Regulation. Market access experts from EFPIA tell the Pink Sheet that this short deadline could delay patient access to complex medicines, such as innovative cancer drugs... Sub. Req'd

Pharma Package Revisions Embed a European Solidarity Mechanism, Says Belgian MEP Ries

(4/16, Nicole Verbeeck, Euractiv) ...On April 10, the European Parliament endorsed a series of far-reaching measures aimed at making medicines more available, accessible, and affordable; while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, all with higher environmental standards. "With this revised legislation, I am really hopeful for what's ahead for Europe. We're aiming to make healthcare better for everyone by ensuring that treatments are easy to get, affordable, and available no matter where you live," Belgian MEP Frédérique Ries told Euractiv... Full

Reuters Pharma Europe 2024 – Day Two

(4/17, Pharma Phorum) ...And we're live on site all day again on Day Two of Reuters Pharma Europe 2024 in Barcelona. Following on from yesterday's insights and networking, today holds in store a further multi-track platter of presentations to look forward to. From launch strategy and commercializing gene therapy to digital tools and the dying hype over GenAI, to a data-driven Medical Affairs future and unveiling the patient-centric paradigm, as well as contemplation of how to mend a broken health system – Day Two is sure to offer a little something for everyone... Full

How Global Healthcare Partners and Indian Pharma Companies Are Contributing to Affordable Medicines

(4/16, Express Pharma) ...Dr Anil Gulati, Chairperson and CEO, Pharmazz highlights that our country plays a pivotal role in delivering quality-certified medications at significantly lower costs, with its dominance in generic medicine production, resilience amidst the COVID-19 pandemic, leadership in vaccine manufacturing, and collaborative efforts in research and development... Full

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