EMA concept paper on revision of biosimilar G-CSF guideline

August 3, 2015 7:00 AM

Last week, the European Medicines Agency (EMA) released a concept paper on its planned revision of specific guideline for biosimilars containing recombinant granulocyte colony-stimulating factors (G-CSF).

The current guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor (G-CSF) provides recommendations for the non-clinical and clinical development of recombinant G-CSF claimed to be similar to a reference product already authorised in the European Union (EU).

The guideline was one of the first product-class specific biosimilarity guidelines and came into effect in February 2006. Since then, several biosimilar filgrastims have been licensed in the EU. It is proposed that the guideline should be updated based on the experience gained with marketing-authorisation applications and scientific advices on biosimilar filgrastims.

The draft concept paper has been released for a three-month consultation period and it is anticipated that, the draft revised guideline will be released for consultation in the first semester of 2016.

The concept paper can be reached from here.

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