Novartis Gets Approval For Remicade Biosimilar In Europe

Novartis NVS announced that its generic arm, Sandoz, obtained approval for Zessly, a biosimilar version of Johnson & Johnson JNJ's Remicade, in Europe.

Zessly is approved for use in all indications of the branded drug including rheumatoid arthritis, adult Crohn's disease, pediatric Crohn's disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

The approval from the European Commission is based on review of a comprehensive development program, including analytical, preclinical and clinical data, which confirmed Zessly matching Remicade in terms of safety, efficacy and quality.

The approval will strengthen Sandoz's already strong biosimilar portfolio with five marketed biosimilars (Omnitrope, a human growth hormone; Binocrit, an erythropoiesis-stimulating agent used to treat anemia; and filgrastim for neutropenia under the brand names Zarzio outside the United States and Zarxio in the United States).

Rixathon (biosimilar rituximab), approved in Europe in 2017 to treat blood cancers and immunological diseases (also approved in the EU as Riximyo under a duplicate marketing authorization); and Erelzi (biosimilar etanercept), approved in Europe in 2017 to treat multiple inflammatory diseases.  

With Zessly's approval, Sandoz will now have six approved biosimilars in its portfolio. Zessly is the third biosimilar which has been approved by the EC in the last 12 months for Sandoz.

The FDA also approved biosimilar Erelzi in 2016. However, the launch is pending in the United States due to an ongoing litigation with Amgen AMGN.

We note that Sandoz acquired the biosimilar of infliximab from Pfizer PFE in February 2016 for the 28 EU countries plus Norway, Iceland and Liechtenstein that form the European Economic Area.

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