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Regulatory Focus™ > News Articles > EU to Unveil New Follow-on Biologic Guidelines in Late Q1

EU to Unveil New Follow-on Biologic Guidelines in Late Q1

Posted 06 January 2012 | By Alexander Gaffney, RAC 

European Medicines Agency Executive (EMA) Director Guido Rasi told Reuters on Friday that the agency plans to release final guidelines on follow-on biologics-also referred to as biosimilars or biogenerics-in March or April of 2012, with draft guidelines on the approval process to follow a month or two later.

The initial guidelines will reportedly detail the requirements for copies of several types of biologic drugs.

EMA has had a regulatory pathway for biosimilars for several years, and has already approved some biosimilar products, including generic human growth hormone (HGH) and erythropoietin (EPO).

Rasi said that he felt confident about the safety profile of biosimilars, and added that the products may even advance the safety profiles of the original drugs.

I don't really have concern about the level of safety (of biosimilars)," said Rasi. "What is a question mark is efficacy, since many biotechnology products are now being improved."


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