Search Results for “biosimilar ” – Page 2 – media

FDA Approves Fresenius Kabi’s Tyenne, a Biosimilar of Actemra for the Treatment of Autoimmune Diseases

Don Tracy, Associate Editor Medication is the first tocilizumab biosimilar approved in the US for both IV and subcutaneous use for autoimmune diseases, such as rheumatoid arthritis and juvenile idiopathic arthritis. Fresenius Kabi announced today that the FDA has officially approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), for the treatment of multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis. Developed with the focus of being more accessible and affordable for patients, Tynne is the first tocilizumab biosimilar to be approved by the FDA for intravenous (IV) and subcutaneous use. This is Fresenius Kabi’s third biosimilar approved in the United States, following Stimufend (pefilgrastim-fpgk), a biosimilar to Neulasta, and Idacio (adalilmumab-aacf), a biosimilar to Humira.1 “Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the U.S. is a moment of great pride for Fresenius Kabi. ...
- Source: drugdu
- 172
- March 11, 2024
FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs

Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
- Source: drugdu
- 136
- March 7, 2024
Henlius Adalimumab Biosimilar Received sNDA Acceptance Notification from the NMPA

Shanghai, China, 29th February 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis，pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA)，bringing new hope to pediatric patients and their families. As of now, HANDAYUAN has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. Autoimmune diseases are a group of diseases caused by the body’s immune system attacking its own organs or tissues[1]. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases[2]. Currently, autoimmune diseases are difficult to cure, and once it occurs, most patients need long-term to lifelong medication. Some autoimmune diseases are particularly dangerous and severely affect the quality of life of patients, posing a threat to their lives and ...
- Source: drugdu
- 78
- March 6, 2024
Henlius Adalimumab Biosimilar Received sNDA Acceptance Notification from the NMPA

Shanghai, China, 29th February 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis，pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA)，bringing new hope to pediatric patients and their families. As of now, HANDAYUAN has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. Autoimmune diseases are a group of diseases caused by the body’s immune system attacking its own organs or tissues. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases. Currently, autoimmune diseases are difficult to cure, and once it occurs, most patients need long-term to lifelong medication. Some autoimmune diseases are particularly dangerous and severely affect the quality of life of patients, posing a threat to their lives and ...
- Source: drugdu
- 143
- March 2, 2024
Biosimilar Insulins Promise Patients New Choices, But Competition Is Still Lacking

Insulin prices have long been a pain point for diabetics. The big three insulin manufacturers have cut prices across their product lineups, but potential competition from other biosimilar insulins is still in earlier stages of development. By FRANK VINLUAN Inflation remains a top consumer gripe, but the higher cost of milk and eggs is negligible when compared to insulin. Spending on insulin has tripled in the past decade, topping $22 billion in 2022, according to research from the American Diabetes Association. While some of that increase is due to a growing patient pool, it’s also due to rising prices. The inflation-adjusted cost of insulin increased 24% from 2017 to 2022. Lower-cost insulin is becoming available to more Americans with diabetes. Implementation of the Inflation Reduction Act last year was a catalyst. One of the federal law’s provisions set a $35 cap on the monthly out-of-pocket cost for insulin. Though the ...
- Source: drugdu
- 87
- January 30, 2024
CVS Caremark to kick AbbVie’s Humira off some formularies in favor of cheaper biosimilars

This year, CVS Health plans to employ the classic “out with the old, in with the new” mantra when it comes to AbbVie’s Humira. Come April 1, the branded drug will be replaced by cheaper biosimilars across the company’s major commercial formularies nationwide. The move is part of CVS Caremark’s efforts to expand the adoption of biosimilars. As it stands, the U.S. biosimilar market is expected to grow from less than $10 billion in 2022 to more than $100 billion by 2029, CVS Caremark cited in a recent press release. The company is “committed” to ramping up adoption of the cheaper biologic drugs and enabling customer choice, CVS Health’s executive vice president and president of CVS Caremark David Joyner noted in a statement. “By preferring biosimilars that have a significantly lower list price than their reference product, CVS Caremark is putting our customers in the driver’s seat to best meet ...
- Source: drugdu
- 142
- January 6, 2024
Regeneron fends off Viatris’ Eylea biosimilar with patent win

Armed with a new victory over Viatris in a patent dispute, Regeneron can knock off one contender in the Eylea biosimilar race. A West Virginia judge ruled that Viatris’ proposed biosimilar violates a Regeneron patent that covers ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist suitable for intravitreal administration to the eye. That patent is expected to expire in June 2027. Viatris, a generic and biosimilar specialist created by Pfizer through the combination of its Upjohn business with Mylan back in 2020, was the first to file for a coveted Eylea biosimilar in 2021. Regeneron struck back with its suit in 2022, arguing that the proposed copycat steps on 24 of its patents. The complaint was later trimmed to three, according to Bloomberg. Viatris has since offloaded its biosimilars unit to Biocon Biologics in a $3.33 billion cash-and-stock deal. Amgen tried to get into the litigation ...
- Source: drugdu
- 167
- January 3, 2024
The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™, have been published in The Lancet Rheumatology.

The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™ (BAT1806/BIIB800), have been published in the prestigious international rheumatology journal, The Lancet Rheumatology (impact factor IF = 25.4). This research, derived from a global multicenter, randomized, double-blind, active-controlled Phase III clinical study (ClinicalTrials.gov, NCT03830203; EudraCT, 2018-002202-31), reveals outcomes from the initial treatment phase (TP1). The study, conducted in 54 centers across five countries (China, Ukraine, Poland, Georgia, Bulgaria), included a 24-week initial treatment phase (TP1) followed by a subsequent 24-week secondary treatment phase (TP2). A total of 621 patients with moderate to severe rheumatoid arthritis, unresponsive to methotrexate, were enrolled. During the trial, participants received investigational drug therapy with an initial dose of 8mg/kg, administered intravenously every four weeks, either BAT1806/BIIB800 or the reference Tocilizumab. The study consisted of two treatment stages (TP1 and TP2), with 50% of the control group transitioning to BAT1806/BIIB800 treatment in TP2 until ...
- Source: drugdu
- 118
- December 22, 2023
First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Ipilimumab Biosimilar HLX13

Shanghai, China, Dec 13th, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first subject was dosed for a phase 1 clinical trial of the company’s independently developed ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) in China. Immune checkpoint inhibitors are playing a crucial part in immunotherapy, which has emerged in recent years as a novel approach to combating tumour cells with distinct advantages and enormous promise [1]. In addition to PD-1/L1 and LAG-3, CTLA-4 is also an inhibitory immune checkpoint which expressed on regulatory T cells and activated T cells and has a higher affinity to B7 molecules compared with CD28, thus can competitively bind to B7 molecules to inhibit the proliferation and activation of T cells [2]. Anti-CTLA-4 fully human monoclonal antibody (mAb) can block the inhibitory effects of CTLA-4 on the co-stimulation signal necessary to T cell activation and can increase the number ...
- Source: drugdu
- 125
- December 16, 2023
Samsung Bioepis, J&J Ink Settlement and License Deal for Stelara Biosimilar

By Tyler Patchen Samsung Bioepis has inked a settlement and license agreement with Johnson & Johnson, which will settle all U.S. patent litigation and allow for the commercialization of a biosimilar for the arthritis drug Stelara, known as SB17. According to Thursday’s announcement, Samsung Bioepis’ license period for its Stelara biosimilar will kick in on February 22, 2025. However, all the other terms of the deal were labeled as confidential and no further details were revealed. The BLA for the SB17 drug is under review by the FDA. If the drug is approved, it will be commercialized by Sandoz.   The issues between J&J and Samsung Bioepis come from the South Korean biotech filing a petition for an Inter Partes Review of J&J’s Stelara, or ustekinumab patent. According to a legal intelligence website lexology, Samsung Bioepis stated that the claims of J&J’s patent were invalid.  Patent protections over the use of ...
- Source: drugdu
- 132
- December 4, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.