BioThera claims a world first with BAT1806, saying it is the first tocilizumab biosimilar approved by the NMPA or any other regulatory agency around the world.
BAT1806 has been approved in China for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA) and cytokine release syndrome (CRS).
Meanwhile, the drug is being assessed by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Important approval as COVID-19 infections spread
The reference product, Actemra, is approved in the US for the treatment of rheumatoid arthritis (RA), giant cell arthritis (GCA), systemic sclerosis-associated interstitial lung disease (SSc-ILD), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), cytokine release syndrome (CRS), and most recently coronavirus disease 2019 (COVID-19).
Bio-Thera developed BAT1806, a tocilizumab injection, around the biosimilar guidelines of China's NMPA, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). It is a recombinant humanized monoclonal antibody targeting interleukin-6 receptor (IL-6R), which specifically binds to soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits signaling mediated by sIL-6R or mIL-6R.
A range of analytical similarity studies, non-clinical similarity studies and clinical studies have confirmed that BAT1806 is ‘highly similar to the reference drug in terms of quality, safety and efficacy,’ says Bio-Thera, announcing the Chinese approval yesterday.
Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solution said, “We are delighted that BAT1806 has been approved as the world’s first tocilizumab biosimilar. This is a very important step for Bio-Thera in the field of rheumatology, and it is more important to patients as its approval provides a new treatment option to many patients with autoimmune conditions.
“China is currently facing an unprecedented spread of the COVID-19 infections, and BAT1806 provides a treatment option to many hospitalized COVID-19 patients with severe lung conditions”.
BAT1806 is Bio-Thera Solutions’ third biosimilar to receive regulatory approval by the NMPA. It is also developing several additional biosimilar products, including proposed biosimilars for Simponi, Stelara and Cosentyx - which are all currently in global Phase 3 studies - and a proposed biosimilar for Nucala, which is currently in a Phase 1 study.
Pending decisions in the EU and US
In 2021, Biogen made a commercialization and license agreement to develop, manufacture and commercialize BAT1806 (known as BIIB800 by the company) in countries outside China. The marketing authorization application for BAT1806/BIIB800 was accepted by EMA in September last year and the FDA in December.
Other biosimilars for Actemra could be on the horizon: Fresenius Kabi’s MSB11456 Biologics License Application was accepted by the FDA in August and the company expects a decision this year; while South Korea's Celltrion is developing its candidate CT-P47.