Friday, June 28, 2013

Two Remicade biosimilars get EU CHMP nod for use in all approved indications of Remicade

Celtrion and Hospira have received positive CHMP opinion and we expect biosimilar copies should reach the market around March 2014.  With the approval granted for all indications, the entire sales of Remicade in EU is now exposed.

Although biosimilars so far have not been able to cut into the brand market in the past,  but with Celtrion indicating a 30 percent discount, this should allow a decent market share and if the real world evidence reinforces existing evidence on safety and efficacy, the market share should further increase.
In the application dossiers, Remsima and Inflectra both  have been shown to be similar to the biological medicine Remicade, a monoclonal antibody that has been authorised in the European Union since 1999. Remsima and Inflectra are recommended for authorisation in the same indications as Remicade, covering a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.

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