Friday, March 14, 2025

Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary

(3/13, Denise Myshko, Managed Healthcare Executive) ...Lumicera Health Services has made a purchase agreement with Anda, a subsidiary of Teva Pharmaceutical, for a lower-priced biosimilar version of Stelara (ustekinumab). Under this agreement, Lumicera's discounted net acquisition cost for the unbranded biosimilar (ustekinumab-aekn) is estimated to generate $120 million in annualized savings for clients. Lumicera uses a pass-through, acquisition cost-plus model. Plan sponsors will save between $112,000 and $336,000 per patient per year compared with the annual per-patient cost of the reference product... Full

KLN Selected by Teva as its Exclusive 4PL Service Provider in the Greater Bay Area

(3/13, AJOT) ...Theodor Wee, General Manager of Teva Greater China, said, "The stable supply of medicines is crucial to patient health, and Teva is always committed to exploring innovative initiatives to improve patient access to medicines continuously. This collaboration also exemplifies Teva's global ‘Pivot to Growth' strategy. In the future, we will accelerate to bring more medicines that will meet the evolving needs of patients. Teva looks forward to partnering with Kerry Pharma to promote medical integration and innovation in the Greater Bay Area, leveraging each other's strengths as a model of cooperation."... Full

Teva Enhances Pharma Distribution System in China

(3/14, BioSpectrum) ...This initiative not only strengthens Teva's presence in Hong Kong, Macau, and the Greater Bay Area, enhancing product distribution system resilience and driving quality and efficiency improvements in the regional pharmaceutical industry, but also marks a crucial step in building an efficient, transparent, and sustainable pharmaceutical supply model that prioritises patient care... Full

Celltrion Keeps Pace With Ustekinumab Discounts As It Launches US Stelara Rival

(3/13, Dave Wallace, Generics Bulletin) ...As Celltrion launched Steqeyma, the firm disclosed a discount of 85% to the current wholesale acquisition cost of Stelara, "to help improve patient access". The level of discounting aligns with the known discounts so far for ustekinumab biosimilars in the US, with Teva, Sandoz and Biocon Biologics all announcing discounts of between 80% and 90% when they launched in late February after frontrunner Amgen kicked off competition at the start of the year... Global Sub. Full

Richter Welcomes Generic Xarelto And Pradaxa Impact As Revenues Climb In 2024

(3/13, Dean Rudge, Generics Bulletin) ...Gedeon Richter enjoyed a solid 2024 as it capitalized on key generic launches and progressed significantly with proposed biosimilars to both Prolia/Xgeva and Actemra/RoActemra. The Hungarian firm also shed light on its strategy over the next decade in a newly-launched ten-year strategic plan. Gedeon Richter championed the impact of its recent European launches of generic versions of Bayer's Xarelto (rivaroxaban) and Boehringer Ingelheim's Pradaxa (dabigatran), as its total Pharma revenues climbed by 10% in constant currencies, and 13% as reported, to HUF844.8bn ($2.30bn) in 2024... Global Sub. Full

‘I Don't Feel We Lost Momentum': Takeda's Oncology Execs Sharpen Focus After Restructuring

(3/13, Gabrielle Masson, Fierce Biotech) ...Takeda's revamped R&D strategy means the drugmaker's oncology leaders are prioritizing work in tumors across thoracic, gastrointestinal (GI) and hematology, while pushing the Japanese company's cell therapy work focus to the backburner. "We're not doing this in a prescriptive way that would never consider anything outside of that," Teresa Bitetti, president of Takeda's global oncology business unit, told Fierce Biotech. "But we are looking at areas that we've defined because of the white space, in terms of the unmet need, because of where the science is moving and where our strength lies."... Full

Coherus Prepares To Wave Goodbye To Udenyca – And 30% Of Its Staff

(3/13, Dave Wallace, Generics Bulletin) ...With Coherus BioSciences gearing up to exit the biosimilars space altogether – having late last year struck a deal to divest its Udenyca (pegfilgrastim-cbqv) franchise to Intas in a transaction worth more than half a billion dollars – the firm has reported a rise of nearly two-thirds in Udenyca sales in 2024, while at the same time setting out plans for "organizational streamlining" and the loss of around 30% of its 225 employees as it moves ahead to focus on innovative immuno-oncology products... Global Sub. Full

Indian Generic Players Begin Price War Over Generic Empagliflozin Launches

(3/13, Adam Zamecnik, Generics Bulletin) ...The launch of generic forms of empagliflozin by several domestic players follows the patent expiry for the compound patent protecting Boehringer Ingelheim's originator drug Jardiance...Approval in CKD was outlined by Boehringer as a key opportunity for further growth. The drug was approved by Indian regulators for use in adult CKD patients in February 2024. As a result, multiple Indian companies have now joined the lucrative market with their own generic forms of empagliflozin and its combinations, starting a price war of sorts among the competitors... Global Sub. Full

Big Pharma Walked Away From Mental Health. Why Some Are Coming Back.

(3/14, David Wainer, The Wall Street Journal) ...Pharmaceutical companies are cautiously returning to the field of mental health after years of neglect. Despite significant patient demand, innovation in mental health drugs has lagged behind, partly because of challenges in identifying clear biological targets and reliance on subjective patient reports in clinical trials. Recent acquisitions of Karuna Therapeutics and Intra-Cellular Therapies by Bristol Myers Squibb and Johnson & Johnson, respectively, signal a potential revival in the field, driven by promising new treatments and the potential for significant financial rewards... Sub. Req’d

The New CEO of GoodRx Wants to Lean Into Brand Names and Speed Up The Drug Discount Company's Growth

(3/13, Shelby Livingston, Endpoints News) ...GoodRx has been in a rut. In its almost five years as a public company, its revenue flatlined, and its stock price plunged about 90%. Its founders stepped down as co-CEOs in 2023, and temporary leadership revamped the business model in hopes of spurring growth. Now, GoodRx's new CEO, Wendy Barnes, says her job is not so much to fix anything, but to speed up the company's current plans - and to revive the stock price. Specifically, she's focused on finding more ways to help patients access brand-name drugs... Full

The Drugstore Industry Is Struggling. Here's What Could Be in Its Future.

(3/13, Bill Peters, MarketWatch) ...During an earnings call in June, Tim Wentworth, the chief executive of Walgreens Boots Alliance Inc., said the way that pharmacies did business was "not sustainable" and required new approaches amid pressures from inflation, competition and drug-industry middlemen that have prompted industrywide store closures. But as the drugstore chain prepares to go private and its rival CVS Health Inc. experiments with smaller stores, some analysts and researchers see a possible future with even fewer pharmacies and more online or at-home services — one that raises bigger questions about consumer access... Full

Drugmakers Mallinckrodt and Endo Get a Bump from Tariffs in $6.7 Billion Merger

(3/13, Sabrina Valle, Reuters) ...Mallinckrodt Chief Executive Siggi Olafsson said the companies' operations and products complement each other. With large manufacturing facilities in the U.S., he said the combined company could actually see some benefit from U.S. President Donald Trump's tariffs on imported goods. "We saw (tariffs), in a way, as an opportunity," Olafsson told Reuters, adding that the companies have a manufacturing base in the U.S. for many key products. "That helps us."... Full

Ireland Could Lose Pharma Tax to US After Trump Accusations, Experts Warn

(3/13, Lisa O'Carroll, The Guardian) ...Aidan Regan, a professor of political economy at University College Dublin, said the US president was right to call out the trade imbalance created by US pharmaceutical companies in Ireland, arguing the warning signs have been there for years. "Trump is right. And it was refreshingly honest what he said. I imagine the Irish government would feel the same way if it was Irish companies all over the globe making all their sales in Ireland but shipping their profits offshore," he said... Full

How Trump's Tariffs On India Will Backfire On The US Healthcare System

(3/13, Anushree Jonko, NDTV World) ...Dr. Melissa Barber, a drug costing expert from Yale University, notes that the tariffs could "worsen the demand-supply imbalances" and disproportionately affect the uninsured and poor, per a report in the BBC. The Indian pharmaceutical industry is deeply concerned about the potential impact of these tariffs. Companies like Sun Pharma and Cipla have expressed concerns about the viability of their businesses in the face of increased tariffs...The US healthcare system is already facing significant challenges, including rising healthcare costs and increasing drug prices. The proposed tariffs on Indian pharmaceuticals could exacerbate these issues, making it even more difficult for Americans to access affordable healthcare... Full

Weldon Says WH Axed His Nomination After GOP Lawmakers Balked, Blames Pharma

(3/13, Jessica Karins, Inside Health Policy) ...After the White House unexpectedly pulled the nomination of former congressman and physician David Weldon to lead the Centers for Disease Control and Prevention (CDC) shortly before a planned confirmation hearing Thursday (March 13), Weldon shared a lengthy statement saying he was informed his nomination didn't have the votes to pass on the Senate floor and speculating pharmaceutical companies lobbied against him... Sub. Req’d

LTC Pharmacies Shop IRA Tweak Patterned After Part D Fix To Avert Facility Closures

(3/13, Gabrielle Wanneh, Inside Health Policy) ...A national coalition representing long-term care (LTC) pharmacies says 60% of its members will close facilities around the country unless Congress gives them extra reimbursement for Medicare drugs with negotiated prices starting in 2026. The group is shopping a legislative proposal patterned after a payment tweak made decades ago to the Part D program and hopes the measure will be wrapped into Congress' upcoming reconciliation package... Sub. Req’d

CMS May Engage In Medicare, 340B Discount Deduplication ‘Eventually,' Ex-CMS Official Says

(3/13, Cathy Kelly, Pink Sheet) ...CMS did not have time before the January 1, implementation date for negotiated prices to establish a process protecting manufacturers from providing Medicare negotiated prices and 340B discounts on the same drug, former CMS official John Coster told the Pink Sheet. Coster, who worked on the process for "effectuating" the first round of Medicare negotiated prices while at the agency, said CMS was busy implementing the basic framework under a very tight deadline. He acknowledged manufacturers' "frustration" with CMS not helping prevent duplication initially, but said the agency could become involved later... Global Sub. Full

Bipartisan Bill Aims to Combat PBMs' Medicaid Spread-Pricing

(3/13, Brian Nowosielski, Drug Topics) ...A group of US Senators introduced the Protecting Pharmacies in Medicaid Act this week, according to a news release. If signed into law, its provisions will limit the ability of pharmacy benefit managers (PBMs) to conduct the often-criticized spread-pricing tactic... Full

Health Care Practitioners Sound the Alarm On Middlemen-Imposed Barriers to Patient Care, Need for Policy Change

(3/13, Mike Ybarra, PhRMA) ...Health care practitioners (HCPs), and patients too, are sounding the alarm on unnecessary barriers in the system that can negatively impact patients' access to quality care according to a new survey of HCPs and patients. Specifically, HCPs raised concerns over how pharmacy benefit managers (PBMs) and insurers inappropriately use utilization management tools, like prior authorization, to deny or delay care, ultimately harming the patient and impacting patient access to care. These findings build on another recent poll of Americans' experience with the health care system, which showed Americans face insurer and PBM-imposed barriers to care and demand greater urgency to related policy reforms... Full

Drug Shortages, Affordability Remain Top Concerns in Managed Care Pharmacy

(3/13, Ashley Gallagher, Drug Topics) ...Drug shortages remain an area of concern for the pharmacy industry, with 62% of respondents stating that the number of active drug shortages could potentially increase by more than 25% within the next 5 years, according to data from the Journal of Managed Care & Specialty Pharmacy... Full

Update! 49th International GMP Conference

(3/13, Patrick Day, Lachman Consultants) ...The themes discussed at the conference essentially reiterated the goals of ICH Q10, which aspires to integrate the following three concepts: (1) Establish and maintain a state of control (section 1.5.2); (2) Facilitate continual improvement (section 1.5.3); and (3) Integrate knowledge management and Quality Risk Management (section 1.6). A key reminder for all of us is that these activities are needed regardless of any policy changes affecting the FDA as the industry's goal is to help and protect patients, and this goal never wavers, regardless of political forces... Full

Experts: Strong Design Controls Are Key to FDA Device Approval

(3/13, Joanne S. Eglovitch, Regulatory Focus) ...Linthicum Heights, MD – Sponsors interested in getting their medical device applications approved by the US Food and Drug Administration (FDA) should have robust design controls in place to ensure that devices work as intended without compromising safety and effectiveness, according to two experts speaking at the RAPS Global Regulatory Strategy Conference on Tuesday... Full

The Cost of Prescription Drugs Is Crushing Virginians — President Trump Must Act

(3/14, Tom Garrett, Cardinal News) ...Every day, I hear from Virginians who are struggling to afford their prescription medications. The reality is stark — people are taking half their prescribed doses, skipping days, or simply going without their medications because they cannot afford them. This is not just a healthcare crisis; it is an economic disaster for our communities... Full

Maryland Moves to Make Medicine Cheaper Amid Economic Uncertainty

(3/13, Katie Mettler, The Washington Post) ...The Senate passed legislation allowing for the expansion Wednesday night, following a House vote last month to do the same — setting up the law to be signed by Gov. Wes Moore (D) after the two chambers reconcile any differences in the separate bills. Moore made lowering drug costs a key campaign promise, making advocates of the law confident that their greatest hurdle has been cleared... Sub. Req’d

SIRUM Partners with State of Maryland to Expand Access to Affordable Medication

(3/13, SIRUM) ...SIRUM and Governor Wes Moore announced a new partnership to expand medication access across the state of Maryland. SIRUM, the nation's largest redistributor of surplus medications, will bring its low-cost pharmacy service, Good Pill Home Delivery, to the state's residents. Powered by donated surplus medicine, Good Pill offers 500+ medications with an average cost of $2/month to anyone whose medication costs are too high... Full

Greece, Lithuania Voice High Hopes for Critical Medicines Act

(3/13, Filip Ác and Vasiliki Angouridi, Euractiv) ...Medicine shortages are a common thread across many member states, a result of growing global challenges, but some now express hope the Critical Medicines Act (CMA), alongside the Pharma Package, can provide real solutions...The proposed regulation has been presented against a turbulent geopolitical landscape and it emphasises the crucial role of a strong European-based pharmaceutical industry in the EU's security approach. For Greece, "A resilient global pharmaceutical supply chain depends on flexibility, adaptability, and diversification", said Dr Aris Angelis, general secretary of the Greek Health Ministry... Full

China Should Not Prioritise Low Prices in Drug Procurement Plan, European Lobby Group Says

(3/14, Andrew Silver, Reuters) ...A European business lobby group urged China to take steps not to prioritise low prices over product safety in the country's centralised drug procurement programme. The European Union Chamber of Commerce in China also questioned China's recent investigation into quality concerns of off-patent medicines approved for the programme, calling it "unscientific," and lacking in transparency... Full

IPA's Global Pharmaceutical Quality Summit: New Concerns and Solutions

(3/13, Michele Sinoway, Lachman Consultants) ...The focus of this meeting (as its title implies) was quality, but the panels consisted of people with a myriad of different perspectives. The keynote address was given by Arvind Virmani from the National Institution for Transforming India (NITI), India's top policy think tank. Panels included regulators representing India (Drug Controller General of India), the UK (MHRA), and Europe (EDQM), joined by two ex-FDAers. There were also contributors from other regulated sectors, such as finance and defense, as well as representatives from academia, such as the Indian Institute of Technology Bombay, and organizations such as the Indian Foundation for Quality Management (IFQM), McKinsey, and the Kaizen Institute... Full

Will the Luck of the Irish Waiver Under Trump's Pharma Envy?

(3/13, Brian Maguire, Euractiv) ...The IDA said: "A significant proportion of Ireland's goods exports to the US are in pharma products (45%). US pharma companies operate global supply chains, and exports from Ireland to the US are concentrated in intermediate products within these very integrated supply chains." "The majority of pharma sector exports to the US (approx. 84%) are intermediary goods shipped to the US to be finished in US factories, by US workers, thereby adding value to the US economy."... Full

US Tariff Hikes to Force Pharma Companies to Shut Down or Consolidate: Report

(3/14, Manu Kaushik, Financial Express) ...The Indian pharma sector is facing the prospects of closures and consolidation given the tariff hikes proposed by the US, said a note from Rubix Data Sciences. The higher tariffs will increase the production costs and render the locally-made drugs less competitive in the US market as compared to alternatives from other countries... Full

Japan Recommends Beyonttra, Raises Enhertu Price

(3/14, Lisa Takagi, Pink Sheet) ...Japan recommends approvals for eight new products including BridgeBio/Alexion's acoramidis and BMS's mavacamten. The country also will raise reimbursement prices for 19 products with premiums to encourage market entrance of innovative drugs, which will take effect on April 1, 2025. Average 3% pricing addition will also apply to the products without profit after going through numerous pricing cuts... Global Sub. Full

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