Pegfilgrastim-Bmez(Clariant Ag)

DUBLIN, Feb. 9, 2024 /PRNewswire/ -- The "Injectable Hematology Growth Factors Report" has been added to ResearchAndMarkets.com's offering. Understanding the rapidly advancing sector of injectable hematology growth factors is crucial for stakeholders in the healthcare industry. The latest comprehensive report evaluates the intersection of technology, products, and key players that are shaping this dynamic segment, with particular emphasis on devices designed for patient self-administration. The study presents an in-depth examination of the evolving therapeutic care landscape, highlighting significant developments in the treatment of conditions such as anemia, neutropenia, and thrombocytopenia. It analyzes the shift from traditional vials to prefilled injection devices, a trend that is likely to gain momentum over the following five years, emphasizing the market forces driving this change. Key Highlights from the Report: An in-depth analysis of device strategies and product development factors influencing the injectable hematology growth factors delivery systems. Insight into market dynamics and demographics, underpinning industry growth. An evaluation of therapeutic demand drivers across pivotal segments in healthcare. Comprehensive market data and forecast trends to inform strategic decisions. Profiles of sector participants including business strategies and corporate associations. An assessment of how alliances and partnerships affect the commercialization of drug products. Insights into the economic, technological, and regulatory factors impacting the market. Healthcare administrators, investors, and other stakeholders will benefit from this study's findings that not only chart current market conditions but also project future industry directions. It serves as a critical resource for decision-makers aiming to understand and capitalize on the opportunities presented within this segment. The report's findings are pivotal for a broad spectrum of healthcare professionals, including pharmaceutical decision-makers, device developers, healthcare marketers, and supply chain entities. It is particularly geared towards empowering chronically ill patients and enhancing safety protocols through revolutionary drug delivery methods. Stakeholders are poised to gain substantial insights into the strategies propelling the adoption of injectable hematologic treatments, facilitating informed decisions that align with the compelling trends of self-administered therapeutic care. Discover the Future of Injectable Hematology Treatments As the healthcare industry continues its inexorable march towards more patient-centric and self-managed treatment options, understanding the nuances and intricacies of injectable hematology growth factor treatments becomes ever more critical. The recent report provides these vital insights, demarking a clear view of the path forward. Stay informed on the latest in healthcare advancements and market opportunities. For further information and to explore the depth of this report, interested parties are encouraged to delve into the comprehensive analysis that awaits them. Key Topics Covered: Hematology Market Dynamics Competitive Factors Proliferation of Biological Drugs Product Manufacturers Hematology Growth Factors Devices for Administering Injectable Growth Factors Device Selection - Stability and Material Issues Competitive Landscape Prefilled Syringes Pen Injectors Dual Chamber Pens Emerging Devices Injectable Hematology Growth Factors - Product Assessment Abseamed Accofil Aranesp Binocrit Biograstim Biopoin Epoetin Alfa Hexal Eporatio Filgrastim Hexal Fulphila Granix Grastofil Mircera NeoRecormon Neulasta Neupogen Nivestim Ratiograstim Retacrit Rolvedon Silapo Tevagrastim Udenyca (Coherus BioSciences) Zarzio Ziextenzo Market Assessment Anemia Hematopoietic Stem Cell Transplant Advanced Kidney Disease Neutropenia Predonation of Autologous Blood Company Profiles Companies Mentioned AbZ-Pharma Accord Healthcare Amgen Genentech Hexal AG Medice Arzneimittel Mylan International Novartis Pfizer Ratiopharm Rentscler Biotechnologie Roche Sandoz Stada Arzneimittel AG Teva Pharmaceuticals For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

photobyphm/Shutterstock Ziextenzo (pegfilgrastim) is a long-acting version of filgrastim and is indicated to decrease the incidence of infection in cancer patients. photobyphm / Shutterstock It has been a long time coming, but Sandoz finally won approval in the United States for its biosimilar to Amgen’s Neulasta. This morning, the Novartis subsidiary announced the U.S. Food and Drug Administration (FDA) approved Ziextenzo , the filgrastim biosimilar. Ziextenzo (pegfilgrastim) is a long-acting version of filgrastim and is indicated to decrease the incidence of infection in cancer patients. The infections are manifested by low white blood cell count and associated with a fever in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. A study has shown that each year in the US, more than 60,000 cancer patients are hospitalized with evidence of neutropenia, including fever or infection, with more than 4,000 deaths as a result, the company said in its announcement this morning. Sandoz said it intends to launch Ziextenzo as quickly as possible this year. The biosimilar has been available in Europe since 2018. Carol Lynch, president of Sandoz Inc., said when cancer patients with febrile neutropenia get an infection, it can have serious consequences that impact treatment by delaying or chemotherapy treatment or reducing the chemotherapy dosage. “The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio – the leading filgrastim by market share in the US – including consistent product supply and reliable patient services,” Lynch said in a statement. Sandoz resubmitted its Biologics License Application for Ziextenzo in April after the FDA issued a Complete Response Letter in 2016. When the company resubmitted the BLA, it included new data from a pivotal pharmacokinetics and pharmacodynamics study that compared Sandoz pegfilgrastim with US-sourced reference pegfilgrastim; Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim; and the U.S. with EU-sourced reference pegfilgrastim. PK and PD similarities were demonstrated in all three comparisons, and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups, Sandoz said. That delay though allowed other biosimilars to hit the U.S. market ahead of Ziextenzo. Both Coherus BioSciences and Mylan have both launched their own versions of Neulasta, which last year earned $4 billion, CNBC reported this morning. Biosimilars are something akin to generic drugs for biologics. They are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when the Affordable Care Act was passed in 2010. In 2015, Sandoz won approval for the first biosimilar in the United States. Zarxio is a biosimilar version of Amgen’s Neupogen. hbspt.forms.create({ portalId: "4413123", formId: "c4dda430-e2b0-4083-86f3-ccce0c1d4479" });