Blog Big Molecule Watch December 14, 2020

Adalimumab Biosimilar Update: Shanghai Henlius Biotech’s Approval in China and Celltrion’s Positive Opinion in the EU

Last week, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved its adalimumab biosimilar candidate for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.  Henlius stated that this is its third biosimilar approval in China, following approval of its rituximab and trastuzumab biosimilar products.

Celltrion announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Celltrion’s adalimumab biosimilar candidate, recommending approval of the product for all available indications.  HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare, said that if the product is approved, “Celltrion will be the first company to introduce an adalimumab biosimilar with high concentration and citrate-free formulation.”

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