Latest news with #Soliris
Business Wire
12-06-2025
- Health
- Business Wire
Samsung Bioepis Presents Long-Term Safety Data of EPYSQLI™ (Eculizumab) in PNH at the European Hematology Association (EHA) Congress 2025
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. ('Samsung Bioepis') today presented the long-term safety data of EPYSQLI™ (eculizumab; SB12), a biosimilar to Soliris 1, in paroxysmal nocturnal hemoglobinuria (PNH) at the European Hematology Association (EHA) Congress 2025 held at Milan, Italy from June 12 to 15. Long-term follow-up of EPYSQLI's Phase 3 study showed consistency of safety data between the initial 52-week period and the extended treatment period up to 158 weeks Share EPYSQLI was approved by the European Commission (EC) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in May 2023 and March 2024, respectively 2. The study assessed the long-term safety of EPYSQLI in PNH patients by evaluating the consistency of safety outcomes, particularly serious adverse events (SAEs) between the initial 52-week Phase 3 study period and the extended treatment (ET) period, spanning from 52 weeks to up to 158 weeks. The same maintenance dose of 900 mg EPYSQLI was administered every 2 weeks. A total of 46 patients from the Phase 3 study received ET. During ET, seven patients (15.2%) experienced a total of 14 SAEs with no occurrence of fatal cases, and all patients fully recovered without permanently discontinuing the treatment. The exposure-adjusted event rate (EAER) was comparable between initial 52-week period and ET period (EAER were 0.13 and 0.17, respectively), and there was no statistically difference between initial 52-week and ET period in EAER (p-value = 0.76). The study is consistent with the findings of the Phase 3 study with no newly identified safety signals and no fatal cases occurred throughout the entire treatment period with all SAEs resolving completely. Details of the abstract are as follows 3: Abstract title: Long-Term Safety of SB12 in Paroxysmal Nocturnal Hemoglobinuria: Up to 2-year Extension Treatment Safety Data Abstract number: PB2811 Type: Publication Only Session title: Bone marrow failure syndromes incl. PNH – Clinical Author(s): Jun Ho Jang, Siook Baek, Yumin Baek, Jinah Jung, Ciprian Tomuleasa, Hanna Oliynyk, Theerin Lanamtieng, Soo Min Lim Besides approval by the EC, EPYSQLI is also approved by the U.S. Food and Drug Administration (FDA) and Korea's Ministry of Food and Drug Safety (MFDS) as a biosimilar to Soliris. In countries where EPYSQLI is approved and available, EPYSQLI may not be prescribed and/or dispensed for its unapproved other indications for which Soliris is approved. About EPYSQLI (Eculizumab Biosimilar) in the European Union (EU) EPYSQLI is indicated in adults and children for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). EPYSQLI is not approved for and should not be used for the treatment of generalised myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). EPYSQLI must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with hematological disorders or renal disorders. EPYSQLI EU Important Safety Information The EU Summary of Product Characteristics for EPYSQLI includes the following Special warning and Precautions: Meningococcal Infection Due to its mechanism of action, the use of eculizumab increases the patient's susceptibility to meningococcal infection (Neisseria meningitidis). Meningococcal disease due to any serogroup may occur. To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving eculizumab unless the risk of delaying eculizumab therapy outweighs the risks of developing a meningococcal infection. Patients who initiate eculizumab treatment less than 2 weeks after receiving a tetravalent meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Vaccines against serogroups A, C, Y, W 135 are recommended in preventing the commonly pathogenic meningococcal serogroups. Vaccine against serogroup B where available is also recommended. Patients must receive vaccination according to current national vaccination guidelines for vaccination use. Vaccination may further activate complement. As a result, patients with complement-mediated diseases, including PNH and aHUS, may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH) or TMA (aHUS). Therefore, patients should be closely monitored for disease symptoms after recommended vaccination. Vaccination may not be sufficient to prevent meningococcal infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Cases of serious or fatal meningococcal infections have been reported in eculizumab-treated patients. Sepsis is a common presentation of meningococcal infections in patients treated with eculizumab. All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary. Patients should be informed of these signs and symptoms and steps taken to seek medical care immediately. Other Systemic Infections Patients may have increased susceptibility to other type of serious infections, especially with Neisseria and encapsulated bacteria. Infusion Reactions Administration of eculizumab may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis). Eculizumab administration should be interrupted in all patients experiencing severe infusion reactions and appropriate medical therapy administered. Anticoagulant therapy Treatment with eculizumab should not alter anticoagulant management. PNH Laboratory Monitoring PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days). aHUS Laboratory Monitoring aHUS patients receiving eculizumab therapy should be monitored for thrombotic microangiopathy by measuring platelet counts, serum LDH and serum creatinine, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days). Treatment Discontinuation for PNH If patients discontinue treatment with eculizumab they should be closely monitored for signs and symptoms of serious intravascular haemolysis. Treatment Discontinuation for aHUS If aHUS patients discontinue treatment with eculizumab, they should be monitored closely for signs and symptoms of severe thrombotic microangiopathy complications. The most common adverse reaction observed with eculizumab treatment in clinical trials was headache, (occurred mostly in the initial phase of dosing), and the most serious adverse reaction was found to be meningococcal infection. Refer to the Summary of Product Characteristics for EPYSQLI's full safety information.
Yahoo
15-05-2025
- Business
- Yahoo
New Biologics Reshape the gMG Landscape, but Growth Opportunities Persist for Established and Pipeline Therapies, According to Spherix Global
High rates of biologic naivety, limited switching, and ongoing unmet needs across the gMG landscape create opportunity for brand differentiation. EXTON, PA, May 15, 2025 (GLOBE NEWSWIRE) -- The treatment landscape for generalized myasthenia gravis (gMG) has entered a new era of therapeutic innovation. Since 2022, seven novel targeted biologics have launched, with a robust pipeline poised to continue this momentum. However, findings from Spherix Global Insights' latest Patient Chart Dynamix™: Generalized Myasthenia Gravis (US) reveal that the biologic market remains far from saturated. Adoption barriers on both the provider and patient sides create meaningful opportunities for current and emerging brands to expand their reach. In a survey of 147 biologic-prescribing neurologists, approximately half of gMG patients remain biologic-naïve. Notably, one-third are deemed clinically eligible for a targeted biologic but have not yet started treatment. This gap highlights the complex interplay of prescribing behaviors, patient hesitations, and the need for tailored manufacturer strategies to capture market share. The gMG biologic market continues to shift as recent and anticipated approvals reshape the field. In March 2025, Amgen launched Bkemv, the first Soliris biosimilar, followed by Teva's Epysqli just one month later. Shortly thereafter, argenx received FDA approval for a pre-filled syringe formulation of Vyvgart Hytrulo, enhancing patient convenience. Meanwhile, Johnson & Johnson's Imaavy, an FcRn inhibitor, gained FDA approval in late April, while Amgen's Uplizna is also expected to join the market soon. Pipeline innovation in the gMG landscape remains robust, with several candidates introducing novel mechanisms of action and more convenient delivery methods. Notable developments include Alexion/AstraZeneca's gefurulimab, a subcutaneous C5 inhibitor aimed at improving administration convenience; Regeneron's combination of pozelimab and cemdisiran, offering a dual-modality approach to potentially enhance treatment response; and Novartis' oral therapies—Fabhalta (iptacopan) and remibrutinib—positioned to advance the treatment paradigm. Additional promising candidates include EMD Serono's Mavenclad (cladribine) and RemeGen's telitacicept, both of which may offer differentiation through efficacy, ease of use, and the targeting of persistent unmet needs. According to Spherix's Patient Chart Dynamix™: Generalized Myasthenia Gravis (US), which audited 564 patient charts, the majority of gMG patients currently treated with a biologic remain on their initial therapy. This high level of brand retention underscores both the early stage of market development and the strong satisfaction neurologists report with available agents. However, the path to market success is far from guaranteed. In a landscape where switching remains limited, differentiation at launch is critical. Significant opportunity remains for products that can address clearly defined subpopulations—particularly those experiencing rapid disease progression, refractory to existing biologics, or presenting with rare serotypes such as anti-LRP4+ and seronegative gMG. These patient groups represent areas of persistent unmet need that neurologists continue to prioritize in treatment decisions. Importantly, while clinical positioning is essential, patient influence in treatment initiation cannot be overlooked. Spherix's findings reveal that half of biologic-naïve gMG patients play a significant role in the decision to start therapy. However, patient-initiated requests remain uncommon, indicating that uptake is largely driven by how neurologists frame and present available options. In this context, physician education must extend beyond product knowledge to include effective communication strategies that support shared decision-making and actively engage patients in the treatment journey. While surveyed neurologists generally identify as early adopters of new therapies, the future growth of the gMG market will depend heavily on strategic launch execution, comprehensive provider education, and precise targeting of high-opportunity patient segments. Manufacturers that recognize and respond to these dynamics, tailoring their approaches to meet both clinical and commercial needs, will be best positioned to succeed in an increasingly competitive and rapidly evolving treatment landscape. Spherix will continue to monitor launch performance, shifting prescriber attitudes, and patient-level dynamics through ongoing updates through their suite of gMG services. Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the 'why' behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. CONTACT: Bob Shewbrooks, Neurology Franchise Head Spherix Global Insights 4848794284 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Standard
29-04-2025
- Business
- Business Standard
AstraZeneca says potential US tariffs manageable; faces another China fine
AstraZeneca expects only limited impact from potential U.S. tariffs on pharmaceutical imports, the drugmaker said on Tuesday, asserting it would maintain its 2025 forecasts if the levies end up being in line with other sectors. The tariffs and their erratic rollout by President Donald Trump have heightened fears of global supply chain disruptions, roiling industries that are heavily focused on the United States, the world's biggest consumer market. However, AstraZeneca Chief Executive Pascal Soriot said in a call with journalists that their shock would be something the company could absorb. "If tariffs were implemented in the range we have seen recently in other industries on medicines imported from Europe to the U.S., we would remain within the guidance range we indicated for 2025," he said. Most of the Anglo-Swedish drugmaker's sales come from drugs manufactured either domestically or in Europe, and the company was already shifting some additional manufacturing to U.S. sites, he added. "It's really something that we are going to manage," he added, noting that only minor volumes of U.S.-made drugs are exported to China, shielding the impact of tariffs in the country's second-biggest market after the United States. Also Read Shares in AstraZeneca fell as much as 5.4% before paring losses to trade down 3.2% at about 102 pounds by 0929 GMT, underperforming London's blue-chip FTSE 100, which rose 0.2%. Soriot spoke after the company reported total revenue of $13.6 billion for the first quarter, below company-compiled analysts' expectations of $13.8 billion. Sales of key oncology drugs missed forecasts, impacted partly by changes in U.S. Medicare price negotiations and the transition of rare disease patients from Soliris to newer drug Ultomiris, analysts said. The company also said it could face a new fine in China of up to $8 million over suspected unpaid taxes related to imports of breast cancer drug Enhertu. The update on investigations in China comes after it announced in February that it could face a fine of up to $4.5 million over imports of cancer drugs Imfinzi and Imjudo. Still, core earnings per share of $2.49 beat consensus estimates of $2.27. China accounted for about 12% of overall sales in 2024, while the United States made up 43%. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Business Recorder
29-04-2025
- Business
- Business Recorder
AstraZeneca says potential US tariffs manageable, faces another China fine
AstraZeneca expects only limited impact from potential U.S. tariffs on pharmaceutical imports, the drugmaker said on Tuesday, asserting it would maintain its 2025 forecasts if the levies end up being in line with other sectors. The tariffs and their erratic rollout by President Donald Trump have heightened fears of global supply chain disruptions, roiling industries that are heavily focused on the United States, the world's biggest consumer market. However, AstraZeneca Chief Executive Pascal Soriot said in a call with journalists that their shock would be something the company could absorb. 'If tariffs were implemented in the range we have seen recently in other industries on medicines imported from Europe to the U.S., we would remain within the guidance range we indicated for 2025,' he said. Most of the Anglo-Swedish drugmaker's sales come from drugs manufactured either domestically or in Europe, and the company was already shifting some additional manufacturing to U.S. sites, he added. 'It's really something that we are going to manage,' he added, noting that only minor volumes of U.S.-made drugs are exported to China, shielding the impact of tariffs in the country's second-biggest market after the United States. Shares in AstraZeneca fell as much as 5.4% before paring losses to trade down 3.2% at about 102 pounds by 0929 GMT, underperforming London's blue-chip FTSE 100, which rose 0.2%. AstraZeneca investing $2.5bn in China as drugmaker seeks to recover from scandals Soriot spoke after the company reported total revenue of $13.6 billion for the first quarter, below company-compiled analysts' expectations of $13.8 billion. Sales of key oncology drugs missed forecasts, impacted partly by changes in U.S. Medicare price negotiations and the transition of rare disease patients from Soliris to newer drug Ultomiris, analysts said. The company also said it could face a new fine in China of up to $8 million over suspected unpaid taxes related to imports of breast cancer drug Enhertu. The update on investigations in China comes after it announced in February that it could face a fine of up to $4.5 million over imports of cancer drugs Imfinzi and Imjudo. Still, core earnings per share of $2.49 beat consensus estimates of $2.27. China accounted for about 12% of overall sales in 2024, while the United States made up 43%.
Reuters
16-04-2025
- Business
- Reuters
AstraZeneca unit sued over alleged monopoly on blockbuster drug Soliris
April 16 (Reuters) - AstraZeneca's (AZN.L), opens new tab Alexion Pharmaceuticals was sued in Massachusetts federal court on Wednesday for allegedly misusing its patents to extend its monopoly on its blockbuster blood-disease drug Soliris. Health plan EmblemHealth said in the proposed class action lawsuit, opens new tab that Alexion wrongly obtained new patents to block biosimilar versions of Soliris for four years after its patents on the drug should have expired. EmblemHealth said the alleged scheme violated U.S. antitrust law and could cause overpayments of more than $2 billion for Soliris. Spokespeople for AstraZeneca did not immediately respond to a request for comment on the complaint. "We are concerned about practices that shut down competition and increase drug costs. That's what this litigation is about," an EmblemHealth spokesperson said. EmblemHealth is seeking to represent a class of U.S. Soliris buyers in the lawsuit. Soliris is used to treat rare blood disorders. AstraZeneca earned more than $1.4 billion from sales of the drug in the first half of 2024, according to a company report. EmblemHealth said in the lawsuit that AstraZeneca charges "one of the single highest drug costs in U.S. history" for Soliris, which costs "upwards of $500,000 per patient per year." AstraZeneca's patents covering Soliris should have expired in 2021, but the company misled the U.S. Patent and Trademark Office to obtain more patents with expiration dates "well into the future," according to the complaint. The lawsuit said AstraZeneca used the new patents to "extract settlements" from competitors and delay their biosimilars until March 2025 at the earliest. EmblemHealth asked the court for an order ending AstraZeneca's monopoly on Soliris and an unspecified amount of monetary damages. The case is EmblemHealth Inc v. Alexion Pharmaceuticals Inc, U.S. District Court for the District of Massachusetts, No. 1:25-cv-10985. For EmblemHealth: Thomas Sobol and Gregory Arnold of Hagens Berman Sobol Shapiro; and Mark Fischer and Rob Griffith of Rawlings & Associates
