Bio-Thera Solutions, a China-based biosimilar developer, announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra, an interleukin-6 inhibitor.
Bio-Thera Solutions, a China-based biosimilar developer, announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra, an interleukin-6 inhibitor.
The trial will compare the safety and efficacy of the biosimilar with those of the reference product in patients with rheumatoid arthritis (RA). Bio-Thera plans to enroll 600 patients at more than 45 sites worldwide and says that results of the study are expected in the second half of 2020. In 2021, the company plans to file for regulatory approval in the United States, the European Union, and China.
“Patient enrollment in our phase 3 clinical trial for BAT1806 is another important step as Bio-Thera works to develop and commercialize a pipeline of safe, effective and affordable biosimilars,” said Shengfeng Li, chief executive officer of Bio-Thera Solutions, in a statement.
The company previously announced its phase 1 trial for BAT1806 in July 2018, with the goal of comparing the safety and pharmacokinetics (PK) of the biosimilar with those of the reference.
To date, no tocilizumab biosimilars are approved in highly regulated territories, but multiple developers are targeting the drug. Earlier this month, Mycenax announced positive phase 1 PK, safety, and tolerability data for its proposed biosimilar.
Mycenax says that it plans to apply for scientific advice from the European Medicines Agency and Japan’s Medical Devices Agency in the first quarter of 2019 to finalize its phase 3 study design. The company has indicated that it hopes to secure eventual approval for both intravenous and subcutaneous dosage forms of the biosimilar.
In addition to RA, tocilizumab is also indicated to treat giant cell arteritis in adult patients, polyarticular juvenile idiopathic arthritis, and juvenile idiopathic arthritis. Some data have shown that patients who achieve low disease activity while taking tocilizumab may be able to discontinue methotrexate without worsening disease activity, which is a welcome finding for patients who have adverse events related to concomitant methotrexate therapy.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.