Search Results for “biosimilar ” – media

Baiaotai and Boheng published TOFIDENCE (a reference to Yamero) in the journal “Arthritis Research and Treatment” ® Phase III clinical data of biosimilars developed with tocilizumab

Baiaotai Biopharmaceutical Co., Ltd. (stock code: 688177) is a global biopharmaceutical enterprise based on science and innovation located in Guangzhou, China, hereinafter referred to as “Baiaotai” or “the Company”. The company announced today that the article “Evaluating the Phase 3 Clinical Study of BAT1806/BIIB800 during the Second Treatment Phase (TP2, Weeks 24-48)” co authored with Bojian has been published in the Arthritis Research&Therapy journal. BAT1806/BIIB800 is a product developed by BioNTech and referenced by Yamero ® The biosimilar drug developed with tocilizumab has been launched in Europe and America under the brand name TOFIDENCE ™. In a phase 3 clinical study, rheumatoid arthritis patients with insufficient response to methotrexate were randomly assigned to three treatment groups in a 1:1:2 ratio: (1) using the original drug for intravenous injection of 8mg/kg every 4 weeks until week 48; (2) Treat with the original drug until week 24, then switch to using BAT1806/BIIB800 ...
- Source: drugdu
- 74
- September 13, 2024
FDA approves Sandoz’s Enzeevu as Eylea biosimilar saga continues

The US Food and Drug Administration (FDA) has approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product ...
- Source: drugdu
- 90
- August 14, 2024
TOFIDENCE (BAT1806/BIIB800), a biosimilar developed by BIO-THERA with reference to Amero® (tolizumab), received marketing approval from the European Commission.

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is focused on developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company’s partner, Bojian (NASDAQ: BIIB), recently received notification from the European Commission that it has granted marketing approval to BIO-THERA for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and other diseases. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in April 2024 for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. The European Commission’s approval of the marketing application for TOFIDENCE (BAT1806/BIIB800) ...
- Source: drugdu
- 65
- June 28, 2024
FDA Approves Biocon Biologics’ Yesafili, an Eylea Biosimilar, for the Treatment of Multiple Ophthalmic Conditions

Don Tracy, Associate Editor Approval of Yesafili represents Biocon’s entrance into the US ophthalmology market, following previous approvals in Europe and the UK. Biocon Biologics announced that it has received FDA approval for Yesafili (aflibercept-jbvf), a biosimilar to Eylea (aflibercept). According to the company, Yesafili is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of several ophthalmic conditions such as neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV). Prior to being approved by the FDA, Yesafili was cleared in the United Kingdom back in November, while European approval came in September. Additionally, it is expected to launch in Canada by July 1, 2025.1 “The FDA approval of Yesafili (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into ophthalmology, a new therapeutic ...
- Source: drugdu
- 84
- May 23, 2024
Understanding Payer Perceptions

Tasmina Hydery, PharmD With competition for follow-on-biologics on the upswing—and a potential market boom perhaps around the corner—continued education and course-setting for all stakeholders in charting the access landscape is paramount. Tasmina Hydery, PharmD, Associate Director, Market Access and Healthcare Consulting, Cencora Headlined by the launch of nine biosimilars for Humira (adalimumab), the biosimilars market landscape in the US has undergone a significant shift in the last 18 months. The rapid pace of progress—including the emergence of pharmacy-benefit biosimilars—reflects the investment in this space and the growth forecasted over the next half-decade, when the market could reach more than $100 billion.1 Driven by a robust pipeline of products in preclinical and clinical development, the biosimilars market is poised to continue its upward growth trajectory and expand into new therapeutic areas; however, challenges remain. The adoption of adalimumab biosimilars, thus far, remains low and underscores some of the challenges biosimilar manufacturers ...
- Source: drugdu
- 77
- May 15, 2024
TOFIDENCE™ (tocilizumab-bavi) tocilizumab biosimilar launched for sale in the U.S.

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is committed to developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company today announced that its partner, Bojian (NASDAQ: BIIB), has recently begun marketing and selling TOFIDENCE™ (tocilizumab-bavi) tocilizumab biosimilar in the United States. TOFIDENCE™, a biosimilar developed by BIO-THERA with reference to Amero® (tocilizumab), was approved by the U.S. FDA in September 2023 for the treatment of moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.TOFIDENCE™ is currently available in the U.S. as an intravenous infusion of 80 mg/4 ml, and is sold as an intravenous injection of 80 mg/4 ml. sales, 80 mg/4 mL, 200 ...
- Source: drugdu
- 71
- May 9, 2024
FDA Approves New Herceptin Biosimilar for the Treatment of Multiple HER2-Overexpressing Cancers

Don Tracy, Associate Editor Hercessi marks Accord BioPharma’s first biosimilar to be approved in the United States, with multiple indications for HER2-overexpressing breast and gastric cancers. Image Credit: Adobe Stock Images/Saiful52 Accord BioPharma announced that the FDA has approved Hercessi (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast and gastric cancers. The treatment is also approved for metastatic gastric or gastroesophageal junction adenocarcinoma. According to the company, the approval was based on promising data that showcased Hercessi’s biosimilarity to Herceptin when it came to efficacy, safety, and quality. This includes three studies, one being a Phase III clinical efficacy study, and the other two being Phase 1 PK equivalence studies. All trials displayed safety profiles on par with Herceptin.1 “The approval of Hercessi—our first biosimilar to be approved in the US—marks an important milestone for Accord BioPharma in our efforts ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 92
- May 4, 2024
FDA Approves Stelara Biosimilar Selarsdi to Treat Psoriasis, Psoriatic Arthritis

Davy James Alvotech’s and Teva’s Selarsdi (ustekinumab-aekn), the second FDA-approved biosimilar to Stelara, is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for patients aged 6 years and above with active psoriatic arthritis. Image credit: Maria | stock.adobe.com Alvotech’s and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) has been approved by the FDA as a biosimilar to Stelara (ustekinumab), which represents the second approval for a Stelara biosimilar.1 Selarsdi is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and for patients aged 6 years and above with active psoriatic arthritis. “The approval of Selarsdi—which is our second biosimilar approval this year—underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the US,” Thomas Rainey, ...
- Source: drugdu
- 77
- April 19, 2024
Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints

Shanghai, China & JERSEY CITY, N.J. – April 8, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception from the agreement is China. The randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study (NCT05352516) aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia®) in postmenopausal women with osteoporosis at high risk for fracture. Eligible patients were randomised at a 1:1 ratio to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia®) every six months. The primary efficacy endpoint ...
- Source: drugdu
- 157
- April 10, 2024
BIO-THERA Signs License and Commercialization Agreement with SteinCares for Two Investigational Biosimilars

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that it has signed license and commercialization agreements with SteinCares for two investigational biosimilars. The Company today announced that it has entered into a license and commercialization agreement with SteinCares for two investigational biosimilars. Under the terms of the agreements, SteinCares will have exclusive distribution and marketing rights for the two biosimilars in Brazil and the rest of Latin America. Under the terms of the agreements, BIO-THERA will be responsible for the development, manufacturing, commercial supply and filing of marketing applications with the U.S. FDA and the European EMA for the two biosimilars, and SteinCares will be responsible for the filing of marketing applications for the two biosimilars in Brazil and the rest of Latin America, and for their commercialization. SteinCares is familiar ...
- Source: drugdu
- 166
- March 21, 2024

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