EMEA finalises guidelines on similar biological medicines

The European medical agency EMEA has published five guidelines on similar biological medicines.

In a statement the agency said that the guidelines focused on “quality, non-clinical and clinical issues”. Specific guidelines are provided on medicines containing somatropin, insulin and recombinant granulocyte-colony stimulating factor.

Furthermore, guidelines for medicines which use epoetin will be available later. All guidelines will come into force on June 1st.

Quality issues discussed by the EMEA include making comparisons between the similar generic and the actual product so that the producer can firmly conclude that the product has similar biochemical and physiochemical characteristics and activities.

In the non-clinical and clinical guidelines, the EMEA stated that: “The marketing authorisation application dossier of a biological medicinal product claimed to be similar to a reference medicinal product already authorised shall provide a full quality dossier. Comparable clinical efficacy and safety has to be demonstrated.”

Similar biological products are those which claim to be comparable to already approved biological medicines and treatments. As developing biological medicines is more complex and expensive than conventional chemical development, only a few firms are looking into similar biological products.

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