Registration of Biosimilar Products in Hong Kong: A Comprehensive Guide

Biosimilar products represent a significant advancement in healthcare, offering more affordable alternatives to original biological medicines. This guide provides comprehensive information about the registration process for biosimilar products in Hong Kong.

What are Biosimilar Products?

Biosimilar products are biological medicines that are:

• Highly similar to an already registered biological product (reference product)
• Derived from living organisms
• Have complex molecular structures
• Require special quality considerations due to their biological nature

Key Registration Requirements

Reference Product Requirements

1. Reference Product Eligibility

   • Must be registered in Hong Kong for over 8 years
   • Cannot be another biosimilar product
   • Must have marketing authorization from recognized reference agencies

2. Recognized Reference Agencies

   • US Food and Drug Administration (FDA)
   • European Medicines Agency (EMA)
   • Japan's Ministry of Health, Labour and Welfare
   • Australia's Therapeutic Goods Administration
   • Health Canada

Quality Requirements

1. Comprehensive Characterization

   • Extensive characterization of active substance
   • Detailed analysis of finished product
   • Complete manufacturing process documentation
   • Quality control procedures

2. Comparability Exercise

   • Head-to-head comparison with reference product
   • Detailed analysis of quality attributes
   • Justification for any observed differences
   • Impact assessment on safety and efficacy

Non-Clinical Requirements

1. Required Studies

   • In vitro studies (e.g., receptor-binding studies)
   • In vivo studies when necessary
   • Repeat dose toxicity studies
   • Toxicokinetic measurements

2. Study Design

   • Comparative in nature
   • Designed to detect differences
   • Focus on biological activity
   • Relevant to clinical application

Clinical Requirements

1. Required Studies

   • Pharmacokinetic (PK) studies
   • Pharmacodynamic (PD) studies
   • Clinical efficacy and safety trials
   • Immunogenicity studies

2. Study Population

   • Sensitive to detect differences
   • Appropriate for indication
   • Representative of target population

3. Data Extrapolation

   • Scientific justification required
   • Consideration of immunogenicity
   • Assessment of indication-specific risks

Special Considerations

Immunogenicity Studies

1. Required Components

   • Antibody testing strategy
   • Characterization of immune response
   • Evaluation of antibody impact
   • Risk assessment for different indications

2. Study Design

   • Comparative approach
   • High-risk population focus
   • Long-term monitoring
   • Safety assessment

Pharmacovigilance Requirements

1. Post-Marketing Monitoring

   • 6-monthly PSURs for first 2 years
   • Annual PSURs for next 3 years
   • Adverse reaction reporting
   • Risk management plan

2. Risk Management

   • Educational materials for healthcare professionals
   • Patient information materials
   • Risk mitigation strategies
   • Post-marketing surveillance

Labeling Requirements

1. Mandatory Information

   • Biosimilar product statement
   • Product and manufacturer details
   • Registered indications
   • Clinical study information
   • Substitution warning

2. Prohibited Claims

   • No bioequivalence claims
   • No clinical equivalence claims
   • No automatic substitution claims

Best Practices

For Applicants

1. Preparation

   • Early planning
   • Complete documentation
   • Quality-focused approach
   • Risk assessment

2. Documentation

   • Comprehensive quality dossier
   • Detailed comparability data
   • Clear justification for differences
   • Complete clinical data

For Healthcare Professionals

1. Prescribing Considerations

   • Review of safety data
   • Patient monitoring
   • Adverse event reporting
   • Risk assessment

2. Patient Education

   • Product information
   • Risk communication
   • Monitoring guidance
   • Reporting instructions

Contact Information

For further information or assistance:

• Pharmacy and Poisons Board

  • Website: www.ppbhk.org.hk

• Drug Office, Department of Health

  • Website: www.drugoffice.gov.hk