Is a biosimilar as safe and efficacious as the biological reference medicine product?

    Yes, a biosimilar is as safe and efficacious as the biological reference medicine product. For a biological product, whether biosimilar or original, to be launched in the European Union, it must first be assessed by European Medicines Agency (EMA) and then authorised by the European Commission (EC). The same EMA evaluators do assess both potential […]

    Yes, a biosimilar is as safe and efficacious as the biological reference medicine product. For a biological product, whether biosimilar or original, to be launched in the European Union, it must first be assessed by European Medicines Agency (EMA) and then authorised by the European Commission (EC). The same EMA evaluators do assess both potential innovator biotechs and biosimilars, and the review process for both types of products does therefore follow the same rigorous standards. These EMA standards, which have influenced other regulatory authorities (including WHO), have been specifically designed to guarantee a comparable degree of safety and efficacy as that of the originator. In addition to this biosimilar development review process, which is founded on a comprehensive comparability exercise, the available clinical evidence/knowledge of the original product provides further guarantees and safeguards for the therapeutic reliability of these biosimilars in clinical practice. Once approved in the EU, a biosimilar is just another biotech product, with the same guarantees required of the original.

    In general terms, you can find all the information available in EMA webpage http://www.ema.europa.eu/ema/

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We focus on the research, production and commercialization of recombinant proteins added value through the utilization of CuraMab® with specific human cell lines
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