Biosimilar, biobetter and next generation therapeutic antibodies

On November 18, 2010, the European Medicine Agency (EMA) released a draft guideline on similar medicinal products containing monoclonal antibodies (mAbs), following a workshop organized by the agency in London on July 2, 2009. The guideline discusses relevant animal model, non-clinical and clinical studies that are recommended to establish the similarity and the safety of a biosimilar compared to an originator mAb approved in the European Union (EU). The end of consultation and the deadline for comments is May 2011. Legislation establishing an abbreviated approval pathway for biosimilars was signed into law in March 2010 in the US and the Food and Drug Administration (FDA) is currently working to define the rules for its implementation. To contribute to the debate, the Editorin-Chief and the Associate Editor of mAbs encourage the submission of manuscripts on biosimilar mAbs including views, commentary and research reports from regulatory authorities, originator, generic laboratories, academic scientists and patent attorneys of different regions. These should explain various situations and standpoints as recently discussed during the 6 European Antibody Congress and encourage additional dialog. To start the process, in this issue of mAbs, Mark McCarmish (Sandoz) details the advantages of strategies aiming to produce highly similar antibodies. Future issues will contain position papers from a US originator company, an Asia biosimilar company and others. Biosimilars, follow-on biologics, biogenerics, biobetters, biosuperiors, second and third generation antibodies are terms used Biosimilar, biobetter and next generation therapeutic antibodies