China NMPA Approves Adalimumab Biosimilar

On November 7, Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) approved QLETLI®, a biosimilar to AbbVie’s HUMIRA® (adalimumab). QLETLI® is the first adalimumab biosimilar approved by the NMPA and has been approved for the treatment of three autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. This is the second biosimilar approved by the NMPA, following approval of Shanghai Henlius Biotech’s rituximab biosimilar HLX01 in February 2019. Bio-Thera Solutions currently has biosimilars to AVASTIN® and ACTEMRA® in Phase III clinical trials and is also pursuing biosimilars to SIMPONI® and STELARA®.

 

 

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