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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
Yahoo
06-05-2025
- Business
- Yahoo
FDA approves Selarsdi injection as interchangeable with Stelara
Teva Pharmaceuticals and Alvotech have announced that the US Food and Drug Administration (FDA) has approved the Selarsdi (ustekinumab-aekn) injection as interchangeable with reference biologic Stelara (ustekinumab). As of 30 April, Selarsdi is now available and interchangeable in all presentations that correspond with Stelara, including the treatment for both adult and pediatric patients with psoriatic arthritis, plaque psoriasis, ulcerative colitis, and Crohn's disease. Selarsdi's approved presentations include a subcutaneous injection with 45mg/0.5ml and 90mg/ml in a single-dose prefilled syringe, as well as 45mg/0.5ml in a single-dose vial. The approved presentation is also for intravenous infusion with 130mg/26ml in a single-dose vial. Teva Pharmaceuticals US biosimilars senior vice-president Thomas Rainey said: "The FDA's confirmation of full interchangeability for Selarsdi is an important development for patients and providers seeking to expand access to this important treatment. "Teva's recent launch of two biosimilars – Selarsdi and Epysqli – coupled with a rich pipeline of assets expected to launch over the next few years, position Teva to establish a strong leadership position in the growing landscape of biosimilars and to drive growth for the company as it embarks on the next phase of its strategy." Ustekinumab, the active component in Selarsdi, is a human monoclonal antibody (mAb) that targets the p40 protein. This protein is a shared component of interleukin (IL)-12 and IL-23 cytokines, which are critical in treating immune-mediated conditions such as psoriasis and psoriatic arthritis, as well as inflammatory conditions such as ulcerative colitis and Crohn's disease. Alvotech developed and produces Selarsdi, leveraging Sp2/0 cells and a continuous perfusion method. The injection has been approved as Selarsdi in the US and introduced under various names in different regions, including Jamteki in Canada, Uzpruvo in Europe, and Ustekinumab BS (F) in Japan. Applications are being reviewed in several nations worldwide. The strategic partnership between the companies, initiated in August 2020, was established for the exclusive commercialisation of five biosimilar product candidates of Alvotech. In July 2023, the collaboration expanded to include two additional biosimilars and new presentations of two previously collaborated products. Including Selarsdi, the companies have seen two biosimilars developed by them gain US regulatory approval with interchangeability. Alvotech and Teva noted that they have three additional biosimilar candidates under review by the US regulator: a proposed biosimilar for Simponi (golimumab) and Simponi Aria (golimumab), AVT05, and AVT06, which is a proposed biosimilar for Eylea (aflibercept).
