Busy Week for Biosimilars Worldwide - Big Molecule Watch

  • United States:  On July 13, an FDA advisory committee voted to recommend approval of Sandoz’s biosimilar to Enbrel® (etanercept). The recommendation was to approve the biosimilar for all indications for which Enbrel® is currently approved:  rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis.
  • Asia:  On July 15, Biocon and Fujifilm launched  their biosimilar to Sanofi’s Lantus (insulin glargine) in Japan.  Insulin glargine is indicated for treating diabetes.
  • Europe: Samsung Bioepis announced on July 17 that the EMA has accepted its Marketing Authorization Application for a biosimilar to Humira® (adalimumab).  If approved, marketing of this product will be handled by Biogen.  Adalimumab is indicated for treating rheumatoid arthritis, plaque psoriasis, Chron’s disease, ulcerative colitis, psoriatic arthritis
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