EMEA issues biosimilar guidances

The EMEA's CHMP issued guidance for demonstrating comparability of biosimilar products containing recombinant erythropoietin or G-CSF. For EPO products, the agency said efficacy should be demonstrated with two randomized, parallel group trials and said confirmatory studies should be double-blind. The agency recommended patients with renal anemia as the target population, as these patients are most sensitive to the effects of EPO. The agency also said trials should include a titration phase and a maintenance phase and should use hemoglobin responder rate or hemoglobin maintenance rate and epoetin dosage as co-primary endpoints, with transfusion requirements as a secondary endpoint. Equivalence must be demonstrated for both subcutaneous and IV administration. The guidelines also call for safety data from at least 300 patients and at least 12 months of immunogenicity data. The sponsor also must have a pharmacovigilance plan to address immunogenicity and potential rare serious events. ...