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 ...
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 ...
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 ...
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, ...
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 ...
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 ...
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. ...
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 ...
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 ...
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 ...
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