Novartis' Sandoz scores EU approval for Remicade biosimilar

The European Commission has given its approval to Sandoz, Novartis’ generics and biosimilars unit, for its biosimilar version of Janssen’s Remicade (infliximab) and other products, known as Zessly.

The therapy has been authorised in all the indications of its reference product, which includes the treatment of rheumatoid arthritis, adult Crohn's disease, paediatric Crohn's disease, adult ulcerative colitis, paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

The decision was based on data showing that Zessly matched its reference product in terms of safety, efficacy and quality, and marks the sixth biosimilar approval for the firm.

"The European Commission approval for Zessly is a key milestone in bringing this important medicine to appropriate patients," commented Sandoz CEO Richard Francis. "Biosimilars, such as Zessly, help to address a significant unmet need for earlier patient access to biologic medicines and are at the heart of our Sandoz commitment to improving and extending lives."

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