Bio Thera’s QLETLI (biosimilar, adalimumab) Receives NMPA’s Approval for Auto-Immune Diseases in China

Bio Thera’s QLETLI (biosimilar, adalimumab) Receives NMPA’s Approval for Auto-Immune Diseases in China

Shots:

  • The approval of QLETLI is based on P-III study resulted in meeting its 1EPs, demonstrating bio-similarity to the reference product, Humira (adalimumab) including clinical/nonclinical, PK/PD data
  • The approval of QLETLI marks the first approval in a regulated market from Bio Thera’s biosimilar portfolio and is the second biosimilar to be approved by NMPA
  • QLETLI (BAT1406) is an anti-TNF- α mAb, available as a prefilled syringe for SC injection, indicated for all indications including rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis of the reference product, Humira in China

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