Therapeutic Advances in Hematology (12/01/2015) Vol. 6, No. 6, P. 267; Gascon, P.

The next few years will see the availability of biosimilar monoclonal antibodies (MoAbs), the first of which will be rituximab and trastuzumab. Compared with the first biosimilars, MoAbs are more complex in terms of molecular weight and number of amino acids. They are also anticancer drugs rather than just supportive treatments. This gives rise to questions such as, "How are regulatory agencies to assess their clinical efficacy, immunogenicity, and safety?" and, "Is the neoadjuvant clinical setting the best to evaluate them?" Regulators must make decisions regarding interchangeability between an originator molecule and a biosimilar and extrapolating efficacy results from one pathology to another. Approval of the biosimilars of rituximab and trastuzumab will require resolutions to issues including appropriate pharmacovigilance, extrapolating across indications, and automatic substitution--issues for which there is currently no consensus.

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