2008-12-30-世界卫生组织-INN_Bio_Review_2009_42页_291kb

INN Working Document 05.179 Summary: INN for Biological and Biotechnological Substances

Introduction

The International Nonproprietary Names (INN) system was established by WHO in 1959 to assign unique names to medicinal substances, including biological and biotechnological ones, ensuring global recognition. This review documents the evolution of INNs for these substances, addressing the increasing complexity due to scientific advancements.

Pharmacological Classification

Biological and biotechnological substances are classified pharmacologically into groups such as antimicrobial polypeptides, blood products, glycosylated compounds, monoclonal antibodies, and insulin derivatives. Each group is categorized based on mechanism of action, aiding healthcare professionals in identification.

Current Status of Stems and Systems

INN stems and schemes facilitate unique naming by incorporating letter groups. Examples include:

• Stems: -mab for monoclonal antibodies, -tim for thyroid medicine intermediates, and others for specific substance types.
• Pre-stems: e.g., -ganan for antimicrobial polypeptides.
• INN Schemes: Systematic approaches for gene therapy or glycosylated proteins, using prefixes, infixes, and suffixes.
• No stems/schemes: Groups like growth hormone antagonists or toxins lack specific naming structures unless a stem applies.

General Policies

Key policies guide INN assignment:

• Blood products and vaccines: Not assigned INNs; use scientific names or pharmacopoeial standards.
• Glycosylated compounds: Differing glycosylation patterns use Greek letters and prefixes.
• Monoclonal antibodies: Standardized to -mab suffix, with prefixes for species and random elements for euphony.
• Gene therapy: Uses a two-word scheme with prefixes and suffixes for genes and vectors.
• Challenges include distinguishing recombinant vs. natural forms and microheterogeneity in glycoproteins.

Summary of INNs Assigned

Specific INNs are assigned to biological substances like blood coagulation factors, erythropoietins, and vaccines, following stem-based naming conventions. For instance:

• Blood factors: Eptacog activates with alfa- prefixes.
• Antibodies: E.g., adalimumab for TNF inhibitors.
• Ongoing updates ensure names reflect product variations and advancements.

Current Challenges

The INN system faces challenges from highly complex recombinant products, structural differences in foreign-host expressed proteins, and the need for novel policies for emerging biotechnologies like gene editing and advanced vaccines. Regular reviews and updates are required to adapt to these complexities.

See the provided document for full details on specific INNs and policies.