First Biosimilar Making “Paragraph IV” Certification under China’s New Patent Law: Bio-Thera Solutions Announced NMPA Acceptance of aBLA for Tocilizumab

On November 8, 2021, Bio-Thera Solutions, Ltd. announced that China’s National Medical Products Administration has accepted the marketing authorization application for BAT1806, a biosimilar of Roche’s Actemra® (tocilizumab), which is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R).  Actemra® has been approved in the United States for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome.

Roche listed three patents directed to medical uses and Bio-Thera made Type 3, Type 4.1, and Type 4.2 certifications with respect to these patents.  Bio-Thera is the first biosimilar applicant to make a Type 4 patent certification since the release of China’s patent linkage system, “Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial),” on July 4, 2021.  This system is similar to the U.S. system with respect to the types of patent certifications: for registered patents on approved biologics, biosimilar applicants must certify: (1) there is no relevant patent registered; (2) the registered patent has expired or has been declared invalid or the biosimilar applicant has a license; (3) there is a registered patent, and the biosimilar applicant will not market the drug until the expiration of the patent; or (4) there is a registered patent, but it is invalid, or the biosimilar does not infringe.