EMA backs infliximab biosimilar
medwireNews: The EMA’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of a new infliximab biosimilar for the treatment of various types of arthritis.
Data have demonstrated that the biosimilar (PF-06438179/GP1111) has comparable efficacy, safety, and immunogenicity profiles to originator infliximab. The biosimilar is recommended for same adult and pediatric indications as infliximab, namely rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and other conditions including inflammatory bowel disease and psoriasis.
This announcement follows the approval of PF-06438179 by the US FDA in December 2017.
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