EMEA guidelines on similar biologicals

The European Medicines Agency (EMEA) has published a set of five final guidelines on similar biological medicinal products, aimed at helping the pharmaceutical industry in the development of this new type of application for marketing authorization.

A general regulatory guideline on similar biologicals was finalized in September 2005 and the ones published this month gives guidance on quality, non-clinical and clinical issues. The product class specific annexes to the latter two give guidance for certain groups of medicines: those containing insulin, somatropin and recombinant granulocyte-colony stimulating factor, and come into effect from June 1. In addition, a further class specific annex for medicines containing epoetin will also be available shortly, says the EMEA.

...and two concept papers