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Large partnerships between academia and industry are emerging as a possible solution to the problems surrounding stratified medicine. In this Perspectives article, the members of the RA-MAP Consortium reflect on the challenges and benefits of working in such a partnership.
The goal of a development programme for a biosimilar product is to prove its biosimilarity to the reference product, rather than independently establish its safety and efficacy. In this Perspectives article, the authors describe the US FDA's rigorous approach to the assessment of biosimilarity for proposed biosimilar therapeutic proteins, including those intended to treat rheumatologic conditions.
