Two companies that focus on the development of biosimilar products, Celltrion, Inc. and Hospira, Inc., have received backing by the EMA (European Medicines Agency) to produce biosimilar versions of Remicade. The medicines, called Remsima and Inflectra, are the first biosimilar versions of a monoclonal antibody to be recommended for approval.
Remsima and Inflectra are recommended for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis. The price is expected to be 30% cheaper than the price of the original biologic drug. Johnson & Johnson's Remicade has patent protection in most of Europe through February 2015 and in the United States until September 2018. Plus, there could be patent infringement lawsuits in an attempt to block or slow approval of biosimilars.
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