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Novartis gets EU approval for Remicade biosimilar

Basel, Switzerland-based Novartis AG said the European Commission approved the use of the company's Zessly — a biosimilar version of Johnson & Johnson's Remicade.

Biosimilars are nearly identical copies of therapies sold by another company.

The regulator gave the nod for using Zessly, or infliximab, in Europe as a therapy for rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

The approval is based on analytical, preclinical and clinical data — including a phase 3 study — showing that Zessly matched its reference medicine Remicade in safety, quality and efficacy.

Remicade is owned by Johnson & Johnson unit Janssen Biotech Inc. and is marketed by Merck & Co. Inc. in Europe.

Zessly's approval was recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use in March.