Friday, May 30, 2025

‘Obsessive' Teva Aims For $800M Biosimilar Sales By 2027

(5/30, Dean Rudge, Generics Bulletin) ...The Israeli firm says it looks forward to bringing more and more assets to Europe, "leveraging our generic market-leading position to grow our biosimilars business." In generics, the firm plans to diversify its sales away from the US market, aiming for a broader presence in Europe and other international regions..."There is much, much more to come beyond that as we bring through our early stage pipeline," commented Richard Daniell, Teva's European Commercial head, pointing to at least eight biosimilars in Teva's early-stage pipeline... Global Sub. Full

Teva Gives Aggressive Guidance for Innovative Drugs

(5/29, Gali Weinreb, Globes) ...Teva CEO Richard Francis said that the company had added $1 billion to its innovative revenue in the two years since he took up the post, and had broken through the glass ceiling attributed to Austedo. According to the company, this product could reach revenue of $2.5 billion in 2027 and $3 billion in 2030. Teva's guidance is largely based on this product... Full

Fresenius Adds To Denosumab Competitors In Europe

(5/29, Dave Wallace, Generics Bulletin) ...At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi's denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing... Global Sub. Full

Samsung Bioepis Secures Approval for Xbryk Biosimilar in Korea

(5/30, Yeom Hyun-a, ChosunBiz) ...Samsung Bioepis has been approved for the same diseases as the original drug. Following the approval of the Prolia biosimilar 'Obodence®' in April, the approval of the Xgeva biosimilar means the company has secured two products containing denosumab in Korea, the United States, and Europe. This brings the total number of products that the company has received domestic marketing authorization for to 11, enabling all biosimilar products that completed global clinical trials to be commercialized domestically... Full

Dr Reddy's Targets New Launches, Potential M&A as gRevlimid Tapers Off in America

(5/30, Viswanath Pilla, Money Control) ...Leading pharma major Dr Reddy's Laboratories is banking on a multi-pronged strategy to offset the price erosion of its top-selling generic for Revlimid, or lenalidomide, CFO MV Narasimham has said, which would include rollout of biosimilars, launch of weight loss drug Ozempic's generics, aside of acquisitions and licensing deals. The patent for Revlimid, a major contributor to Dr Reddy's topline, is set to expire in US in January 2026, which would open the doors to more competition and revenue loss for the pharma company... Full

Next-Gen COPD Drug from Sanofi, Regeneron Shows Mixed Results in Phase 3 Trials

(5/30, Andrew Joseph, STAT+) ...An experimental COPD medicine from Sanofi and Regeneron Pharmaceuticals produced mixed results in a pair of studies, the companies said Friday, sending both firms' shares down in early and pre-market trading. The drug, called itepekimab, carries high hopes as the companies look for the next medicine that can produce the successes seen with Dupixent, their jointly marketed blockbuster. Dupixent is approved for a number of immune-mediated diseases, and picked up the green light for COPD last year... Sub. Req’d

Alembic Pharma Shares Rise After Getting USFDA Approval for Blood Cancer Drug

(5/30, Juviraj Anchil, CNBC TV-18) ...In an exchange filing, the company said that the US Food & Drug Administration (USFDA) has granted it the 'Final Approval' for Bosutinib Tablets, 100 mg and 500 mg. This drug is used for treating patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance...The company also added that it has received a cumulative total of 223 Abbreviated New Drug Application (ANDA) approvals (200 final approvals and 23 tentative approvals) from the USFDA so far... Full

Korea Approves Amgen's Imdeltar as First Third-Line Treatment for Small Cell Lung Cancer

(5/30, Yeom Hyun-a, ChosunBiz) ...The Ministry of Food and Drug Safety announced on the 30th that it has approved the progressive small cell lung cancer treatment 'IMDELLTRA (IMDELLTRA®; ingredient name talatomab)' by the American company Amgen...IMDELLTRA is the first dual-antibody new drug that activates the patient's immune cells (T cells) to target delta-like ligand 3 (DLL3), which is expressed in 90% of small cell lung cancer patients... Full

Unlocking Biosimilar Potential

(5/29, IQVIA) ...This report presents a case study of Osteoporosis which expects to see the entry of biosimilars in 2025...This report provides the results of a survey of several physicians that are involved in the treatment and management of osteoporosis. The survey aims to understand the current state of knowledge about biosimilars across physician groups and potential barriers to optimal biosimilar use from a physician perspective. The report utilizes the survey findings to highlight some possible solutions to overcome challenges regarding the variable level of knowledge and experience with biosimilars... Full

Drugmakers, Trade Groups and Others Voice Concerns with Pharma-Specific Tariffs

(5/29, Fraiser Kansteiner, Fierce Pharma) ...Some two weeks after the public comment period closed for the Trump administration's Section 232 investigation into the national security implications of pharmaceutical imports, a wide range of drugmakers, trade groups and foreign governments have largely aligned in opposition to potential industry-specific tariffs...Meanwhile, governments from key industry suppliers, including China, the EU and Korea, as well as representatives from range of large drugmakers like Novo Nordisk, Pfizer, Samsung Biologics, Teva Pharmaceutical and Gilead Sciences, also chimed in... Full

Large Pharma Companies Spell Out Reasons Why Tariffs Will Harm US Investments 

(5/29, Anna Brown, Endpoints News) ...On top of comments by Novo Nordisk, Endpoints News also reviewed entries by companies like Sanofi, Eli Lilly, Vertex and AstraZeneca, which also objected to the levies and noted concerns about increases in cost, reduced US investments and supply disruptions...Big pharma companies highlighted in their entries that the pharma tariffs will likely curb US investments, rather than encourage them as President Donald Trump has said they would..Eli Lilly in particular highlighted that tariffs will "deprive manufacturers of necessary capital to both innovate and invest in reshoring," as capital will be redirected to cushion the tariffs' impact... Sub. Req’d

Bristol CEO: Pharma Tariffs Must Not Jeopardize Medicine Supplies

(5/29, Jared S. Hopkins, The Wall Street Journal) ...Bristol-Myers Squibb Chief Executive Chris Boerner said at The Wall Street Journal's Future of Everything festival on Thursday that potential tariffs targeting the drug industry from the Trump administration must not create supply constraints...Boerner said tariffs need to reflect the time it takes to shift manufacturing around, and the complex pharmaceutical supply chain, one dependent on raw materials for drugs coming from across the world, and deciding where and when to invest in manufacturing years ahead, before drugs are made commercially... Sub. Req’d

US May Take Trump Tariff Case to Supreme Court On Friday

(5/29, Erik Larson and Greg Stohr, Bloomberg) ...In a Thursday court filing in Washington, the Justice Department said the decision a day earlier by the US Court of International Trade harmed the government's diplomacy and intruded upon President Donald Trump's exclusive authority to conduct foreign affairs. It asked the US Court of Appeals for the Federal Circuit to put the ruling on hold while the administration pursued a formal appeal... Sub. Req’d

Despite Court Dispute, Other Paths Available For Pharma Tariffs

(5/29, Maaisha Osman, Inside Health Policy) ...Various industry leaders, generic drug lobby group and experts previously told Inside Health Policy tariffs would increase drug costs, create drug shortages, discourage biotech investment and have far-reaching consequences for Medicare, Medicaid and private insurance, which would all face higher pharmaceutical prices. In a sharply worded statement following the initial defeat in trade court, the Trump team signaled it has no intention of backing down from its aggressive trade stance... Sub. Req’d

Can America Dodge a Tariff Bullet?

(5/29, Robert C. Pozen and Ernie Tedeschi, The Wall Street Journal) ...Whatever the outcome of the court battles, Americans should hope that the tariff madness ends. While the lower temporary tariffs weren't as bad as those originally threatened on "Liberation Day," they nevertheless would produce significant adverse effects-higher consumer prices, lower business investment and lower economic growth... Sub. Req’d

Advocates Press OMB To Eliminate Biosimilar PK Study Requirements

(5/29, Gabrielle Wanneh, Inside Health Policy) ...As the Trump Administration seeks to accelerate approval for biosimilars, generics and other alternatives to high-cost prescription drugs, the Biosimilars Forum is urging the administration to weed out unnecessary regulatory processes that delay the determination of biosimilar efficacy and safety and give FDA more flexibility to speed new biosimilars to the market... Sub. Req’d

Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

(5/30, Urte Fultinaviciute, Generics Bulletin) ...The new batch of PSGs consists of 34 new and 14 revised guidances. The majority of them are for products with no approved ANDAs. The last PSG release was in November 2024, with the FDA missing a publication deadline in February. While recent layoffs impacted the agency's capacity to release new guidances, the agency updated its PSG publishing schedule, with further releases now expected in June, August, and November... Global Sub. Full

House E&C Dems Still Looking For Clarity From RFK Jr. On HHS Staffing Cuts

(5/29, Dorothy Mills-Gregg, Inside Health Policy) ...HHS' staffing cuts have damaged the responsiveness o of the country's public health functions, House Energy & Commerce Committee Democrats say in their latest letter to HHS Secretary Robert F. Kennedy Jr., where they reiterate their request for a full accounting of the number of resignations, retirements and layoffs at HHS and demand the secretary publicly testify before the committee... Sub. Req’d

Solicitor General Urges Supreme Court Not to Review An Oklahoma Law for Regulating PBMs

(5/29, Ed Silverman, STAT+) ...For now, the solicitor general brief is a positive for pharmacy benefit managers, Laura Hobbs, who covers pharmacy benefit managers at Washington Analysis, wrote in an investor note. Although she does not expect the Supreme Court to conduct a review, "we believe states will continue to enact legislation that challenges the limits of ERISA preemption. Nevertheless, with (this case) likely to become final, PBMs and their commercial clients have a respite from a serious legal overhang."... Sub. Req’d

CVS, Express Scripts Sue to Block Arkansas Law Barring PBM Ownership of Pharmacies

(5/29, Diana Jones, Reuters) ...CVS and Express Scripts filed lawsuits on Thursday seeking to overturn an Arkansas state law set to go into effect next year that would ban pharmacy benefit managers from owning pharmacies...In a statement, Express Scripts, which is a unit of Cigna Group, said the law will likely bar it from mailing prescriptions to thousands of Arkansas residents through its mail-order pharmacy business... Full

Drug Industry Gets FDA Guidance On Color Additives in Medicines

(5/29, Nyah Phengsitthy, Bloomberg Law) ...The guidance describes considerations for replacing a color additive in drug products, regardless of the reason for the change, according to the Food and Drug Administration's notice in the Federal Register. This includes ensuring the selected color additive conforms with the requirements under the federal Food, Drug, and Cosmetic Act; updating information on labeling, composition statements, and master batch records; and documenting information to support the change... Full

‘The Question Is, What's Going To Happen Next?' – The Future For Biosimilars In Europe

(5/29, Dave Wallace, Generics Bulletin) ...At industry association Medicines for Europe's biosimilars conference in Amsterdam last month, Generics Bulletin sat down for an exclusive interview with Sandoz biosimilars head and Medicines for Europe biosimilars sector chair Isabell Remus, as well as the association's director of biosimilar policy and science Julie Maréchal-Jamil, to discuss the latest developments and the path forward for biosimilars in Europe... Global Sub. Full

Japan Price Cuts For Epkinly and Lunsumio Following CEA

(5/30, Lisa Takagi, Pink Sheet) ...Japan's regulatory authorities have announced additional extraordinary reimbursement price cuts for several drugs following a Cost-Effectiveness Analysis (CEA) process, with Genmab's T-cell-engaging bispecific antibody Epkinly (epcoritamab) and its competitor Chugai/Roche's Lunsumio (mosunetuzumab) both facing a 2.7% cut on August 1. The revisions follow other recent price cuts ranging up to 20% for selected products in Japan under a Market Expansion Repricing scheme, which is applied to drugs that have seen their reimbursement costs substantially exceed initial official calculations... Global Sub. Full

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