logo
  

Biogen, Bio-Thera Say Phase 3 Study Of BAT1806 Met Its Primary Endpoints - Quick Facts

Biogen Inc. (BIIB) and China's Bio-Thera Solutions, Ltd. announced Tuesday results from the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA/RoACTEMRA (tocilizumab). Biosimilars are products that demonstrate similar efficacy and safety to the originator's reference product and are cheaper.

The study met its primary endpoints, demonstrating equivalence to the reference medicine in patients with moderate to severe rheumatoid arthritis (RA) inadequately controlled by methotrexate therapy. The primary endpoint in the study was the American College of Rheumatology 20 percent response criteria (ACR20).

ACTEMRA/RoACTEMRA's primary indication is for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome.

Biogen and Bio-Thera announced a commercialization and license agreement in April 2021 to develop, manufacture and commercialize BAT1806.

As satisfactory results were met, Biogen will make a payment of $30 million to Bio-Thera Solutions. Should certain commercial milestones be achieved, Bio-Thera Solutions will be eligible to receive potential milestone payments. Biogen will also pay Bio-Thera Solutions tiered royalties.

The BAT1806 clinical trial was a global, randomized, multicenter, double-blind, parallel-group, Phase 3 active-control study designed to evaluate the safety, efficacy, immunogenicity and PK of BAT1806 compared to ACTEMRA/RoACTEMRA in 621 patients with moderate to severe rheumatoid arthritis with inadequate response to methotrexate.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Twitter has rolled out the tipping feature called "Tips" for everyone around the globe using the microblogging site with more payment options to choose from, including cryptocurrencies such as Bitcoin. This is a new way for people to receive and show support on Twitter with money. The feature is currently available on iOS and will be available on Android over the coming weeks. Amazon.com has launched weekly Max-Your-Vax Sweepstakes to encourage their employees to get vaccinated against COVID-19. The sweepstakes began on August 6, 2021 and ends on October 21, 2021, with six draws during the sweepstakes period for 18 prizes worth nearly $2 million, including cash prizes, new vehicle or cash and vacation plus 40 hours of Paid Time Off. Target Corp. announced its plans to hire 100,000 seasonal team members at its stores across the country for this holiday shopping season, though fewer than previous years. With this, the company aims to invest in more flexible scheduling, training, pay and benefits for its existing team members. In a statement, the company said it is also offering around 5 million more hours to its existing staff.
Follow RTT