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…
During the first weeks of 2019 a number of biosimilar developers announced updates regarding their plans for the future. Bio-Thera Solutions Partners with Cipla for Bevacizumab Biosimilar Candidate On January 14, 2019, Bio-Thera Solutions Ltd announced that it has entered into a licensing agreement with Cipla Limited for BAT-1706, its…
Guangzhou-based biopharmaceutical company Bio-Thera Solutions recently announced that the China National Drug Administration has accepted for review the BLA for BAT1406, a proposed Humira® (adalimumab) biosimilar. Bio-Thera states that the BAT1406 BLA contains clinical data from a pharmacokinetic/pharmacodynamic (PK/PD) trial and a Phase III confirmatory safety and efficacy study in…