The first ever generic monoclonal antibody therapies have been recommended for approval in Europe. The two biosimilar versions of infliximab (Johnson & Johnson’s Remicade) have passed assessment by the European Medicines Agency’s committee for medicinal products for human use, but will need to be fully approved by the European commission before they can be marketed.
Monoclonal antibodies are significantly larger and more complex than previously approved biosimilars, which include growth hormones and erythropoietin. Proving that they are functionally similar to the original drug is therefore complex. Both manufacturers, Celltrion and Hospira, had to complete human trials to prove that their generic infliximab products were as safe and effective as Remicade in treating autoimmune diseases.
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http://www.rsc.org/chemistryworld/2013/07/biosimilar-approval-steps-complexity
Organic Reactions in Medchem 