Peptide or biologic? The 40-amino-acid border

محدد الحد الفاصل بين الببتيد والمنتج البيولوجي

Settles which side of the regulatory border a molecule sits on — at 40 amino acids or fewer it is a drug and a copy is a generic; above, a protein whose copy is a biosimilar — with the current FDA peptide guidance context.

It is part of the Biosimilar & Biotechnology Studio on the AUPAM Experts' Office platform, is free, is bilingual (English and Arabic), and runs entirely in your browser — nothing you enter is uploaded or stored.

Open the tool →

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Cite as: AUPAM Experts' Office, Peptide or biologic? The 40-amino-acid border — free, in your browser — AUPAM, retrieved 2026-08-31, https://aupameo.org/tools/peptide-border-checker.html