China's NMPA Approves Tocilizumab Biosimilar

The China National Medical Products Administration (NMPA) approved Bio-Thera Solutions’ tocilizumab biosimilar (BAT1806) referencing Actemra for the treatment of several rheumatic conditions.

The drug will be used in patients with rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, and cytokine release syndrome (CRS). BAT1806 is the third biosimilar developed by Bio-Thera to receive regulatory approval in China, following the approvals of Qletli (adalimumab biosimilar) and Pobevcy (bevacizumab biosimilar).

“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,” commented Shengfeng Li, PhD, founder and CEO of Bio-Thera Solutions, in a company statement.

Tocilizumab products are recombinant humanized monoclonal antibodies that target interleukin (IL)-6 receptors, which bind to soluble and membrane-bound IL-6 receptors and inhibit signaling. Actemra is approved for the treatment of RA, giant cell arthritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, CRS, and COVID-19.

The NMPA’s approval was based on positive data from comprehensive analytical similarity studies, nonclinical similarity studies, and clinical studies, which have confirmed that the safety, efficacy, and immunogenicity profiled between the biosimilar and the reference product are “highly similar."

According to Bio-Thera, BAT1806 was created in accordance with the biosimilar guidelines laid out by the NMPA, the FDA, and the European Medicines Agency (EMA). Regulatory approval applications for the biosimilars are currently under review with the FDA and EMA.

The FDA is also reviewing biologics license applications for tocilizumab candidates developed by Biogen and Fresenius Kabi. An application submitted by Biogen is also under review with the EMA. Gedeon Richter along with Enzene and Hetero have tocilizumab biosimilars in development.

In addition to BAT1806, Bio-Thera is developing several other biosimilar products, including biosimilar candidates referencing Simponi (golimumab), Stelara (ustekinumab), and Cosentyx (secukinumab). All 3 of these biosimilars are being evaluated in global phase 3 analyses. A proposed biosimilar for Nucala (mepolizumab) is under investigation in a phase 1 study.