Wednesday, May 21, 2025

Fitch Upgrades Teva to 'BB+'; Outlook Stable

(5/20, Fitch Ratings) ...The upgrades reflects Teva's progress in reducing debt and improving flexibility. Fitch expects continued revenue growth from AUSTEDO and AJOVY, as well as Teva's biosimilar pipeline. Teva's focus on optimizing external spend, prioritizing resource allocation, and modernizing its organization is expected to lead to higher operating margins. Teva's improving cash conversion profile should allow it to continue reducing debt and unlock capital to support its transformation... Full

Celltrion Expects Limited Impact from U.S. Executive Order On Price Reduction

(5/21, Kim Boram, Yonhap News) ...Celltrion Inc., a leading South Korean biopharmaceutical company, said Wednesday it expects limited impact from recent U.S. policy developments stemming from a drug pricing executive order signed by President Donald Trump...It said the MFN pricing rule will provide an opportunity for biosimilars in the long run as it helps the U.S. drug market become more competitive... Full

Key Takeaways from Virtual Generics & Biosimilars Day at UBS

(5/21, StreetInsider.com) ...The analyst quoted John Murphy, CEO of Association for Accessible Medicine saying "With tariffs raising real acquisition costs for drugs, while AWPs are expected to remain flat, this dynamic could lead to pharmacies getting squeezed on PBM reimbursement due to GER contract language. Pharmacies are evaluating whether tariffs trigger force majeure clauses, and the pressures could catalyze a move to cost plus based contracting."... Full

Hikma Eyes $5Bn Sales Target As It Sets Out Plans To 2030

(5/20, Dave Wallace, Generics Bulletin) ...Hikma has set out growth plans that include achieving $5bn in annual turnover by 2030, compared to 2024 turnover of just over $3bn. The firm also said it expected group revenues to grow at a compound annual growth rate of 6%-8% between 2024 and 2027, while eyeing a 7%-9% CAGR for core operating profit over the same period. Hikma's generics business is being renamed Hikma Rx to "reflect its focus on providing differentiated and complex prescription medicines."... Global Sub. Full

India's Gland Pharma Posts Quarterly Profit Fall, Hit by Sluggish U.S. Sales

(5/20, Yagnoseni Das, Reuters) ...India's Gland Pharma, which make injectable versions of generic drugs, reported a 3.1% fall in fourth-quarter profit on Tuesday, weighed down by weaker sales in the U.S., a key region for the company...Production setbacks at Cenexi's facilities in Paris and Belgium for the past two quarters have been weighing on the company's earnings... Full

Aurobindo, MSN Fall To US Nuplazid Patent Expiring In August 2038

(5/21, Dean Rudge, Generics Bulletin) ...Acadia has demonstrated by a preponderance of evidence that Aurobindo infringes claims 4 and 5 of its US patent 11,452,721 shielding its Nuplazid (pimavanserin tartrate) 34mg capsules until August 2038. The ‘721 patent was also found by a US District Court for the District of Delaware to be valid, handing defeat also MSN Labs, which had stipulated to infringement...Beginning in July 2020, Acadia has filed complaints for patent infringement against several generics manufacturers, including Aurobindo, Teva, Hetero Labs, MSN Laboratories, and Zydus Pharmaceuticals (USA)... Global Sub. Full

J&J Hits Back Over Private-Label Stelara Biosimilar In US

(5/20, Dave Wallace, Generics Bulletin) ...After being refused an injunction as part of ongoing litigation over a private-label ustekinumab biosimilar being marketed in the US by Sandoz and Samsung Bioepis, Stelara originator Johnson & Johnson is continuing to pursue an appeal. However, newly-unsealed court documents suggest the brand company had demonstrated a likelihood of success - and reveal further details about the case, including the identity of the PBM involved and why the injunction request was denied... Global Sub. Full

Aurobindo Racks Up Another Biosimilar Nod With Filgrastim In UK

(5/20, Dave Wallace, Generics Bulletin) ...Aurobindo's CuraTeQ has received approval from the UK's Medicines and Healthcare products Regulatory Agency for its Zefylti (filgrastim) biosimilar. The MHRA approval for Zefylti follows multiple recent European biosimilar nods for CuraTeQ as well as a previous UK biosimilar approval in November. Aurobindo sees biosimilars as "one of the core businesses" for the company and plans 10 launches by 2030... Global Sub. Full

Ritedose Pharmaceuticals Receives FDA Approval for Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL)*--Addressing Nationwide Shortage of the Essential Drug

(5/20, Ritedose Pharmaceuticals) ...The 2.5 mg/0.5 ml dosage rounds out Ritedose's complete portfolio of albuterol treatments, as the company currently has approved applications for (2.5 mg/3 mL (0.083%), 1.25 mg/3 mL and 0.63 mg/3 mL) strength products as well. This new dosage also helps address a nationwide shortage of the essential drug, which has been reported by the FDA since October 2022. Ritedose estimates that the dosage will be available starting in the second quarter of 2025... Full

IL-5 Biologics Well-Positioned to Expand Respiratory Reach, Analyst Says

(5/20, The Pharma Letter) ...Anti–interleukin five (IL-5) biologics such as mepolizumab and benralizumab have shown significant efficacy in reducing moderate and severe exacerbations in both asthma and chronic obstructive pulmonary disease (COPD), according to new real-world data presented at the 2025 American Thoracic Society (ATS) International Conference... Sub. Req’d

Roche Needs More US Data On Key Cancer Drug, FDA Advisers Say

(5/20, Damian Garde, Bloomberg Law) ...Independent experts voted eight-to-one that the results of a pivotal Roche trial, which enrolled just 9% of its total patients from the US, weren't applicable to the domestic population. They asked the Swiss company to gather more data. Roche said in a statement it would continue working with the FDA on a regulatory path forward. The vote is a setback in Roche's efforts to broaden the approval of Columvi, which is currently cleared for adults whose lymphoma has persisted despite two or more rounds of treatment... Sub. Req’d

U.S. FDA Conducting Inspection at Samsung Biologics Facilities in S. Korea

(5/21, Chang Dong-woo, Yonhap News) ...The U.S. Food and Drug Administration is currently conducting an on-site inspection of Samsung Biologics Co.'s production facilities in South Korea, industry sources said Wednesday...FDA officials reportedly visited the company's third and fourth plants Monday to review operations and safety protocols. Site inspections by overseas regulators at South Korean biomanufacturing plants are considered rare and are being closely watched by the industry... Full

For GLP-1s and Biosimilars, Some Celebration, Some Concern, Survey Finds | MHE 2025 Pharmacy Survey, Part 3

(5/20, Peter Wehrwein, Managed Healthcare Executive) ...Almost half (45%) of the respondents indicated that they believe that the makers of the brand-name "originator" products are figuring out ways to keep biosimilars from gaining a significant market share. A smaller proportion (18%) indicated that they agreed with a statement that pointed a finger at pharmacy benefit managers, saying their formulary exclusions, rebates and other practices were the biggest impediment to biosimilars gaining market. The same proportion of respondents indicated agreement with a more optimistic statement, which said that Humira (adalimumab) and Stelara (ustekinumab) biosimilars "have tipped the balance and biosimilars will continue to gain acceptance."... Full

US Health Authorities to Set Targets for Lowering Drug Prices

(5/20, Bhanvi Satija, Reuters) ...The new pricing targets would focus on OECD nations that have a gross domestic product per capita of at least 60% of U.S. per-capita GDP, the department said. Trump wants prescription drug prices to drop by between 59% and 90%. Wall Street analysts and legal experts have said his order would be difficult to implement and is likely to face legal challenges... Full

Trump Administration Reveals 'Most Favored Nation' Drug Price Country Targets

(5/20, Max Gelman, Endpoints News) ...The Trump administration has said that it wants drug developers to offer those lower prices to consumers to buy directly. If they don't comply, the administration would pursue regulation to force the lower prices. HHS said it expects drug manufacturers to comply with this directive for all branded products that don't have generics or biosimilars available...A spokesperson for PhRMA told Endpoints News that while the industry is committed to working with the Trump administration, "socialist price controls could devastate America's leading ecosystem, putting investments, jobs and R&D at risk."... Sub. Req’d

HHS Sets Pricing Target for Trump's Most Favored Nation Drug Price Model

(5/20, Laura Joszt, MA., AJMC) ...Shortly after the order was signed, the pharmaceutical industry criticized it, with Stephen J. Ubl, CEO of the Pharmaceutical Research and Manufacturers of America, known as PhRMA, redirecting attention to pharmacy benefit managers (PBMs), insurers, and hospitals as the reason prices are high in the US. "Importing foreign prices from socialist countries would be a bad deal for American patients and workers," Uble said in statement... Full

HHS Most Favored Nation Scheme To Include Only Brand-Name Drugs

(5/20, Maaisha Osman, Luke Zarzecki, Inside Health Policy) ...The pricing targets will address long-standing disparities that leave American consumers paying three to five times more than patients abroad for the same medications -- even when those drugs are manufactured in the United States, according to HHS. The Trump administration is also expected to push for drug prices to be increased in other countries to make up the difference. "This is about fairness," CMS Administrator Mehmet Oz said in the Tuesday statement. "We're done subsidizing the rest of the world while our own citizens struggle to afford life-saving treatments."... Sub. Req’d

All Branded Drugs Not Facing Generic, Biosimilar Competition Must Abide by MFN Order in 'All Markets,' HHS Tells Pharma

(5/20, Eric Sagonowsky, Fierce Pharma) ...While industry analysts largely reacted that the event wasn't as bad as feared, there was some commentary that the lack of delineation between different segments of the U.S. drug market—Medicare, Medicaid and the commercial market—could raise future alarm bells. The industry is likely to come out strongly against the HHS guidance. Immediately in the wake of the EO signing ceremony, Stephen Ubl, CEO of U.S. trade group PhRMA, said in a statement that "importing foreign prices from socialist countries would be a bad deal for American patients and workers."... Full

Editorial: The Real Cost of Trump's Cheap Drug Promise

(5/20, Eduardo Porter, The Washington Post) ...Trying to bully other countries into realigning the price of meds to favor the U.S. fits Trump's general modus operandi. He might, for instance, use access to the Medicare and Medicaid markets as leverage to force drug companies to raise their prices in other countries. And yet, Trump's bullying in other domains has not really worked according to plan so far. And, even if it did work for pharma, it risks bringing scant benefit to Americans at a high cost to the world... Sub. Req’d

AHA Says New Tariffs Could Worsen Drug Shortages

(5/20, Jeff Lagasse, Healthcare Finance) ...The American Hospital Association has expressed concern about drug and other shortages that may occur as a result of tariffs newly implemented by the Trump administration on items such as pharmaceuticals, medical devices and personal protective equipment. Other low-margin, high-use medical goods come from international sources, the AHA said, such as syringes, needles and blood pressure cuffs... Full

FDA Issues Generic Drug Development Guidance to Support Approval

(5/20, Nyah Phengsitthy, Bloomerg Law) ...The FDA issued 48 product-specific guidance documents on Tuesday that outline the agency's recommendations for developing generic drugs that treat asthma, allergic reactions, and chronic obstructive pulmonary disease...The agency also touted Tuesday its current efforts to help lower drug prices by improving access to generic medicines. The FDA doesn't have a direct role in drug pricing, but can encourage competition between manufacturers that would result in cheaper drugs on to the market... Sub. Req’d

Insulin Factory Funding Set for Cuts in California Budget Plan

(5/20, Andrew Oxford, Bloomberg) ...Facing delays and a $12 billion deficit, a revised budget plan the governor rolled out last week would use $45 million lawmakers previously set aside for that plant to instead fill holes in the state's finances. The proposal is just one of several ways the governor is aiming to balance the state's budget, including a plan to end free health care for most undocumented immigrants and tapping into special funds. The governor is also planning to use the remaining $5 million of the $50 million earmarked for the factory to buy the asthma drug Albuterol at a low cost and distribute it to schools for use by students, officials from the Department of Health Care Access Information told legislators on Tuesday... Sub. Req’d

New York Senate Passes Legislation to Make Prescription Drugs, Healthcare More Affordable and Accessible

(5/20, The New York State Senate) ...The New York State Senate today passed legislation to reduce the cost of prescription drugs, expand healthcare access, and promote health equity for patients in New York. The bills included in this package address critical gaps in drug pricing, patient coverage, and healthcare accessibility, ensuring that New Yorkers have more affordable options and greater transparency in their healthcare choices... Full

Michigan Health Purchasers Coalition Reveals Significant Drug Price Differences Among Hospitals in Similar Geographic Areas

(5/20, The Morning Sun) ..."These reports highlight a huge disparity in hospital pricing across the state," said Bret Jackson, President of MIHPC. "By using the ASP as a benchmark, we clearly display how much hospitals are price gouging Michiganders when it comes to common drugs and the need for urgent action on transparency and accountability from the hospitals."... Full

Maryland Governor Signs Law to Expand Powers of the State's Prescription Drug Affordability Board

(5/20, Ed Silverman, STAT+) ...The move was hailed by consumer advocates who hope the Prescription Drug Affordability Board, which is designed to function much like a state utility commission, will usher in era of lower medicine prices for everyone who lives in Maryland. But the new law was criticized by the pharmaceutical industry for pursuing an "unproven" strategy toward lowering expenses... Sub. Req’d

Trump Won't Force Medicaid to Cover GLP-1s for Obesity. A Few States Are Doing It Anyway.

(5/21, Lauren Sausser, KFF Health News) ...Liz Williams, one of the report's authors and a senior policy manager for the Program on Medicaid and the Uninsured at KFF, said she was not aware of any other state Medicaid programs joining the list since then. Looking ahead, the remaining states may be reluctant to add a new, expensive drug benefit while they brace for potential federal cuts coming from Congress, she said. "As the budget debate, federally, is developing, that may impact how states are thinking about this," Williams said... Full

Commission Taking ‘Due Account' Of Scathing Report On EU Clinical Trial Bottlenecks

(5/20, Vibha Sharma, Pink Sheet) ...A strongly-worded report by the European federation of research-based drug companies, EFPIA, highlights persistent regulatory fragmentation and operational inefficiencies in the EU's clinical trial system. It particularly criticizes the rigidity of the Clinical Trials Information System, and recommends expediting review timelines for clinical trial applications in the EU. The European Commission says it is analyzing EFPIA's feedback as well as suggestions from other stakeholders, and emphasizes that these concerns are being taken into account, especially in the context of upcoming initiatives like the 2026 EU Biotech Act... Global Sub. Full

BioNTech Expands Partnership with UK Govt, Pledging £1 Billion Investment

(5/20, The Pharma Letter) ...As part of the agreement, BioNTech is committed to investing up to £1 billion ($1.33 billion) over the next 10 years. The company said its efforts will be supported by a grant of up to £129 million for a period of 10 years by the UK government, which marks one of the largest grants of its kind in UK history for a pharmaceutical company. The grant is part of the UK government's mission to enhance its life sciences sector and support innovative companies with the aim to unlock progress in medical science, noted BioNTech... Sub. Req’d

Access to Diabetes Care in Lower-Income Countries Still Lags for Children, Despite Pharma Efforts

(5/20, Ed Silverman, STAT+) ...Although insulin makers have launched several initiatives to improve access in dozens of low- and middle-income countries, the medicines are reaching only a small fraction of children and young people in these regions during a recent two-year period, a new analysis has found. Specifically, less than 10% of the estimated 825,000 children and young people who needed type 1 diabetes treatment in these 71 countries were covered by access initiatives from the large insulin manufacturers — Eli Lilly, Novo Nordisk, and Sanofi — as well Biocon, which markets biosimilar versions... Sub. Req’d

South Korea Vows More Policy Support, Including for Drugmakers, As US Tariffs Weigh

(5/21, Jihoon Lee, Reuters) ...Government vows measures for pharmaceutical and other sectors. Drugmaker Celltrion unsure if entering US is the right answer. South Korea seeks exemptions through trade talks with US... Full

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