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EMA prepares to issue revised draft biosimilar insulin guideline; market a tough nut to crack as Marvel stumbles again

This article was originally published in SRA

Executive Summary

The European Medicines Agency hopes to release the draft revised version of its insulin guideline for consultation within a couple of months, the agency said1 as it announced that Marvel BioSciences, a marketing company for the India-based MJ Biopharm, has hit another hitch in its efforts to get its biosimilar insulin onto the EU market, withdrawing approval applications for three products that were under evaluation by the EMA2.

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