The European Medicines Agency (EMA) portfolio of approved biosimilar products and guidelines and the related requests for scientific advice continue to expand, with interest increasing in particular in monoclonal antibodies.
The EMA is in the process of adding four more biosimilar product-specific guidelines: A new guideline on recombinant erythropoietins (EPO) was cleared in March to become effective in October, and new guidelines are under development on monoclonal antibodies, follitropin alpha (recombinant follicle stimulation hormone) and interferon beta.
Concept papers on the latter three have gone out for comment. The monoclonal antibody comment period ended in January and the period for follitropin alpha and IFN-beta closed in June. These four will accompany the agency’s existing guides on recombinant human insulin, somatropin, granulocyte-colony stimulating factor (GCSF), low molecular weight heparin, and interferon-alpha.
These product class-specific guidelines address clinical, non-clinical and bioassay issues and fall under EMA’s overarching “Guideline on Similar Biological Medicinal Products,” released in late 2005. The umbrella guideline is accompanied by separate guidelines addressing quality and clinical/non-clinical issues for biosimilars, respectively, which were both released in mid-2006.
The number of biosimilar marketing authorization applications (MAAs) evaluated by EMA has reached 18. Of these, 14 have been approved, one turned down and three withdrawn.
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