Copies. What’s a biologic copy?


A copy is a biological agent that has been launched to the market claiming that has the same properties, in terms of efficacy and safety than those of the biological agent of reference. Nevertheless, the big difference with biosimilars, is that in no case have been developed with the standards of quality required for biosimilars. This is the main reason why these ‘copies’ have not been approved by the most important regulative agencies, as the EMA (European Union) and the FDA (USA); and therefore they will never be commercialized in these countries. Usually, they are produced in India or China and have managed to be commercialized in some countries. But at the present is very difficult for me to know exactly in which countries are available.


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