- 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
Blog Big Molecule Watch July 19, 2016