Naming System for Biosimilar Products

Naming System for Biosimilar Products

Biosimilars are biological medicinal products that are highly similar to an already approved
reference biologic. Due to the complexity of biological products, biosimilars are not identical
copies, which makes clear and region-specific naming systems essential for
traceability, pharmacovigilance, and patient safety.

Why Biosimilar Naming Matters

  • Ensures accurate pharmacovigilance
  • Prevents medication errors
  • Allows effective batch traceability
  • Supports regulatory oversight

Global Concept of INN

The International Nonproprietary Name (INN), assigned by WHO, identifies the active
substance. For biosimilars, the core INN remains the same as the reference product,
while regional regulators apply additional naming rules.

Reference Biologic

Biosimilar 1

Biosimilar 2

Same INN – Regional Naming Differences

US FDA Naming System

The US FDA assigns a distinct nonproprietary name consisting of:

Core INN + hyphen + 4-letter meaningless suffix

FDA-Approved Real Examples

Product Type Nonproprietary Name Brand Name
Reference Filgrastim Neupogen
Biosimilar Filgrastim-sndz Zarxio
Biosimilar Adalimumab-atto Amjevita
Biosimilar Trastuzumab-dkst Ogivri

Adalimumab

+

– atto (FDA suffix)

 

Some of Examples:

European Union (EMA) Naming System

The European Medicines Agency (EMA) uses the same INN for reference biologics and
biosimilars. No suffix or qualifier is added to the nonproprietary name.

INN Brand Name Company
Infliximab Remicade Janssen
Infliximab Remsima Celltrion
Infliximab Inflectra Pfizer

Indian (CDSCO) Naming Practice

India follows a same INN approach for biosimilars and reference biologics.
Differentiation is achieved through brand name, manufacturer, and batch number.

INN Brand Name Manufacturer
Adalimumab Exemptia Zydus
Trastuzumab Canmab Biocon
Bevacizumab Bevatas Intas

Regional Comparison Summary

Region INN Usage Suffix / Identifier
US FDA Same INN Mandatory 4-letter suffix
EMA Same INN None
India (CDSCO) Same INN None
Japan Same INN “BS” notation

Regulatory Insight

Biosimilar naming does not indicate superiority or inferiority.
It is a regulatory mechanism to ensure traceability, safety monitoring, and clear product identification.

This article is written for educational and regulatory awareness purposes and aligns with
US FDA, EMA, WHO, and CDSCO biosimilar principles.

Read More:

  1. Quality Assurance
  2. Formulation Development & Production
  3. What is Contamination Control Strategy (CCS)?
  4. Interchangeable Biosimilars vs Biosimilars vs Reference Biologics
  5. Naming System for Biosimilar Products
  6. Biosimilars and Biologics in Pharmaceutical Industries.
  7. Biosimilars Basics for Patients

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