EMA Unveils Final Guidance for Insulin Biosimilars

Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance issued this week.

The EMA guideline urges using a specific type of test — a cross-over, double-blind hyperinsulinemic euglycemic clamp study with single subcutaneous doses of the test and reference agents — to demonstrate that the reference and proposed insulin are biologically similar.

The clinical trial study population should be homogenous and insulin-sensitive, the guideline says, to best detect potential product-related differences. Normal-weight healthy volunteers or patients with type 1 diabetes may be selected for studies, the EMA says.

The final guideline makes one key change from the draft issued last year. The EMA had urged manufacturers who are planning comparative clamp studies to consider reports that individuals of African, South Asian or Hispanic descent have reduced glucose clearance.

However, the EMA deleted that section in the final version in response to a comment from European Biopharmaceutical Enterprises, which pointed out that since each subject is his or her own control, ethnic differences should not matter.

The guideline is effective Sept. 1. Read it at www.fdanews.com/03-15-EMA-Guideline.pdf. An overview of the comments is at www.fdanews.com/03-15-EMA-Comments.pdf. — Jonathon Shacat