Biosimilars (01/29/2016) Vol. 06, P. 01; Gabbani, Tommaso; Deiana, Simona; Bagnoli, Siro

A study out of Italy reviews the biosimilar of adalimumab (Humira), a human recombinant monoclonal antibody against tumor necrosis factor-alpha that is licensed for the treatment of several rheumatologic diseases and inflammatory bowel diseases. The original biologic drug has worldwide sales of more than $12 billion, but the patent will expire this year in the United States and in 2018 for Europe. The adalimumab biosimilar is already being marketed and used in India, but many other companies are testing adalimumab biosimilars in order to request clearance from the U.S. Food and Drug Administration and European Medicines Agency when the patent expires. In the expected rush to obtain biosimilar approval, researchers suggest "the long-term safety and immunogenicity of these drugs are an issue, but the striking rise of pharmaceutical expenses makes these drugs highly attractive for health care systems and pharmaceutical companies."

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