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.
Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions
December 2nd 2023A survey explores the experiences of health care providers (HCP) throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in New Zealand in 2022.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
CVS Caremark Switches Up Biosimilar Coverage in 2024
November 27th 2023As new biosimilars are added to CVS Caremark’s standard formulary, others are removed. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.
Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?
September 17th 2023On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.
Public Payer in Poland Saves €243 Million by Using Biosimilar TNF Inhibitors
November 11th 2023The use of biosimilars of tumor necrosis factor (TNF) inhibitors within Poland’s public payer saved over €243 million from 2013 to 2021, with about 68% of that coming from the rheumatic musculoskeletal diseases alone.
Real-World Data Confirm Safety, Efficacy of CT-P13 in Inflammatory Diseases
November 9th 2023A real-world analysis from Japan confirmed that CT-P13, an intravenous infliximab biosimilar, had comparable safety and efficacy to the reference product (Remicade; infliximab) in patients with immune-mediated inflammatory diseases.