Filgrastim biosimilar(KASHIV BIOSCIENCES LLC)

Greater Effectiveness and Enhanced Safety Profiles of Biosimilars Compared to Their Reference Biologics Increasing Their Adoption Worldwide ROCKVILLE, Md., July 22, 2024 /PRNewswire/ -- According to a new research report published by Fact.MR, the global Biosimilar Market statistics is estimated to reach a size of US$ 43.8 billion in 2024 and thereafter expand at a CAGR of 8.9% from 2024 to 2034. Global demand for biosimilars is rising as healthcare systems seek cost-effective alternatives to expensive biologic medications. These highly similar biologics are gaining popularity worldwide due to their equivalent efficacy, safety, and affordability. The anticipated growth in the biosimilar market in the coming years will be driven by the expiration of patents on blockbuster biologics and the imperative to reduce healthcare expenditures. Biosimilars are demonstrating significant potential in treating various conditions such as diabetes, autoimmune disorders, and cancer. Their increasing availability is improving patient access to life-changing therapies, particularly in underserved regions with limited healthcare resources. Furthermore, biosimilars are fostering competition in the biopharmaceutical industry, potentially leading to greater innovation and lower prices. As regulatory frameworks evolve and acceptance among patients and healthcare providers increases, biosimilars are expected to become integral to long-term healthcare strategies. Their growing recognition underscores their critical role in addressing global health challenges and ensuring broader access to advanced treatments. For More Insights into the Market, Request a Sample of this Report: Key Takeaways from the Biosimilar Market Study: The global biosimilar market is projected to generate revenue of US$ 102.68 billion by 2034. North America is analyzed to account for 39.1% of the global market share by 2034. The East Asia market is forecasted to reach a valuation of US$ 20.9 billion by 2034. By 2034, the market in Canada is projected to climb to a size of US$ 4.32 billion. Based on application, the hematology segment is estimated to be valued at US$ 7.53 billion in 2024. The online pharmacies segment is expected to hold 27.7% of the market share in 2024. "Public awareness campaigns and educational initiatives are boosting the adoption of biosimilars over traditional biologics, especially in treating chronic illnesses like cancer, diabetes, and autoimmune disorders," says a Fact.MR analyst. Leading Players Driving Innovation in the Biosimilar Market: Amgen PFIZER Inc. Novartis Biocon Ltd. Coherus BioScience Teva Pharmaceuticals Abbvie Viatris Fresenius Kabi Sanofi SA Mylan Amneal Pharmaceuticals, Inc. Single-use Technologies and Continuous Bioprocessing Proving to Be Beneficial Advanced analytical techniques such as nuclear magnetic resonance spectroscopy and high-resolution mass spectrometry are enhancing the characterization of biosimilars, ensuring closer alignment with reference biologics. This increased precision is instilling greater confidence among regulators and healthcare professionals. Innovative manufacturing methods like continuous bioprocessing and single-use technologies are improving the efficiency and cost-effectiveness of biosimilar production, further lowering treatment costs and enhancing accessibility to essential therapies. Research into interchangeability is facilitating the seamless substitution of reference products with biosimilars, simplifying prescription and dispensing processes. Additionally, the therapeutic potential of biosimilars is expanding through the development of biosimilar combinations and biobetters, which represent enhanced versions of existing biologics. As biosimilars receive approvals across multiple indications and enter new therapeutic areas, they are increasingly recognized for their adaptability and wider availability. These advancements are poised to better meet diverse medical needs on a global scale, making biosimilars increasingly beneficial in healthcare systems worldwide. Biosimilar Industry News: In January 2024, Gilead Sciences and Arcus Biosciences announced an updated partnership agreement and a separate equity investment. Gilead invested US$ 320 billion in Arcus common shares at US$ 21 per share. In May 2023, Biocon Biologics and Viatris Inc. announced the introduction of Abevmy in Canada. This medication is a bevacizumab biosimilar of Avastin, originally developed by Roche, and has been approved by Health Canada for use in cancer treatment. In March 2022, Amneal Pharmaceuticals, Inc. declared that the U.S. government had accepted the Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen. In May 2022, the United States Food and Drug Administration (FDA) approved Amneal Pharmaceuticals, Inc.'s Biologics License Application (BLA) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. Get Customization on this Report for Specific Research Solutions: Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Application Hematology Growth Hormone Deficiency Oncology Diabetes Autoimmune Disease Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Product Type Recombinant Glycosylated Proteins Recombinant Non-Glycosylated Proteins Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Distribution Channel Hospital Pharmacies Online Pharmacies Retail Pharmacies More Valuable Insights: Fact.MR, in its new offering, presents an unbiased analysis of the biosimilar market for 2019 to 2023 and forecast statistics for 2024 to 2034. The study divulges essential insights into the market based on product type (recombinant glycosylated proteins, recombinant non-glycosylated proteins), application (hematology, growth hormone deficiency, oncology, diabetes, autoimmune diseases), and distribution channel (hospital pharmacies, online pharmacies, retail pharmacies), across six major regions of the world (North America, Latin America, Europe, East Asia, South Asia & Oceania, and MEA). Checkout More Related Studies Published by Fact.MR Research: Oncology Molecular Diagnostics Market was valued at around $1.7 Billion in 2020 and is anticipated to reach a valuation of US$ 4 Billion by 2031. Oncology Small Molecule Drugs Market has reached a valuation of $79 billion in 2022 and is forecasted to expand at a CAGR of 5.5% to climb to a market size of US$ 135.4 billion by 2032. Hemato Oncology Testing Market is projected to increase from a valuation of US$ 4.33 billion in 2023 to US$ 23.64 billion by the end of 2033. Oncology Biosimilars Market was valued at US$ 4 Billion, and is likely to rise at a Y-o-Y growth rate of 5% in 2022 to reach US$ 4.2 Billion. By the end of the forecast period, the industry is poised to reach US$ 12 Billion. Pegfilgrastim Biosimilar Market is projected to reach a market valuation of US$ 3.66 billion by 2033-end, increasing at a CAGR of 10% over the next ten years. Self-care Medical Devices Market: analysis shows that the global market was valued at US$ 13 Bn in 2020, and is projected to top US$ 20 Bn by 2031, expanding at a CAGR of 6%. About Us:  Fact.MR is a distinguished market research company renowned for its comprehensive market reports and invaluable business insights. As a prominent player in business intelligence, we deliver deep analysis, uncovering market trends, growth paths, and competitive landscapes. Renowned for its commitment to accuracy and reliability, we empower businesses with crucial data and strategic recommendations, facilitating informed decision-making and enhancing market positioning. With its unwavering dedication to providing reliable market intelligence, FACT.MR continues to assist companies in navigating dynamic market challenges with confidence and achieving long-term success. With a global presence and a team of experienced analysts, FACT.MR ensures its clients receive actionable insights to capitalize on emerging opportunities and stay ahead in the competitive landscape.   Contact:  11140 Rockville Pike  Suite 400  Rockville, MD 20852  United States  Tel: +1 (628) 251-1583  Sales Team: [email protected]   Follow Us: LinkedIn | Twitter | Blog  SOURCE Fact.MR

Builds on U.S. biosimilar portfolio of seven products with three commercial and four in pipeline 8th biosimilar expands portfolio into allergy treatments, a new therapeutic area BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the addition of omalizumab, referencing XOLAIR®, to its biosimilar pipeline. Omalizumab is a humanized monoclonal antibody which targets free immunoglobulin E (IgE). It is an injectable prescription drug used to treat a number of chronic conditions such as severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), food allergies, and chronic spontaneous urticaria. It is typically administered in a hospital or clinic setting. The biosimilar was developed by Kashiv BioSciences, LLC and is currently in a Phase III clinical trial, which began in the third quarter of 2023. “We are excited to further grow our biosimilar pipeline with the addition of omalizumab and expand into a new therapeutic area beyond oncology. We are building on the strong success of our first commercial biosimilars. Amneal is committed to providing affordable biologic medicines which will increase access and choice to patients and providers, and drive cost savings to the U.S. healthcare system,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology. “We are pleased to partner with Amneal on our most advanced pipeline product, ADL018, a proposed biosimilar to XOLAIR®. We are building on our highly productive partnership with the commercial success of RELEUKO® and FYLNETRA®, and advancement of additional peg-filgrastim programs. Kashiv is one of a few companies based in the United States to manufacture and receive marketing authorization of multiple biosimilars. By relentlessly focusing on quality and cost-effective development, Kashiv continues to build upon its strong track record of developing and manufacturing high-quality, affordable biosimilars to improve patients’ lives worldwide,” said Dr. Sandeep Gupta, Chief Executive Officer of Kashiv. According to IQVIA®, U.S. annual sales for XOLAIR® for the 12 months ended April 2024 were approximately $3.2 billion. XOLAIR® is a registered trademark of Novartis AG. The financial terms of the transaction were not disclosed, and any incremental expenses associated with these products are contemplated within Amneal’s guidance. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.