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55th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances

Geneva, 16–18 October 2012

Core Content

The 55th Consultation on INNs for Pharmaceutical Substances was held in Geneva from 16–18 October 2012. It brought together experts, stakeholders, and representatives from various organizations to review and discuss the naming of pharmaceutical substances, including biosimilars and cell therapy products. The consultation was preceded by a special meeting on 15 October 2012 focusing on cell therapy products and biosimilars, chaired by Dr. Kevin Grant.

Main Points and Key Information

INN Programme Overview

• The INN Programme is managed by the World Health Organization (WHO) and aims to provide unique, non-proprietary names for pharmaceutical substances.
• The consultation included the review of 112 INN requests, comprising 83 new requests, 25 outstanding requests, and 4 previously selected INNs with objections.
• 102 names were selected for publication in List 109 of Proposed INNs, while 7 were deferred.
• 3 names were rejected due to non-compliance with INN criteria.
• 1 amendment and 1 new stem were approved, with 8 suffixes promoted to the pre-stem list.

Biosimilar Naming Policy

• Biosimilar naming is a contentious issue, as current policies treat glycosylated biosimilars with Greek letter suffixes, while non-glycosylated biosimilars share the same INN.
• Concerns were raised about the exhaustion of Greek letters and the risk of confusion in prescribing due to identical names for different biosimilars.
• Four approaches were suggested:
  1. Continue with the status quo.
  2. Treat all biosimilars as unique products.
  3. Create a biosimilar identifier under WHO guidance.
  4. Encourage regulatory authorities to assign identifiers.
• The first two options were deemed unviable; the latter two were considered preferable.
• There was a consensus that a global naming system for biosimilars is needed, and the INN Programme is best suited to lead this effort.

Cell Therapy INN

• A special meeting was held on 15 October to discuss naming of cell therapy products.
• The USAN naming convention was noted for its short names but was criticized for being process-oriented rather than product-oriented.
• It was agreed that matrices should not be included in cell therapy naming.
• A descriptive naming approach was suggested, but it was noted that long names may be impractical for labeling.
• The INN Committee is urged to consider developing a naming scheme for cell therapies, with a focus on allogeneic and xenogeneic products, which are more commercially viable.

Collaborators and Updates

• BAN (British Approved Names): 2012 edition with a first supplement in August 2012.
• FDA: Has not approved biosimilars and uses prefixes on INNs for some products. The USAN system is used for naming in the US, with a legal process for handling conflicts.
• IUPAC: Is finalizing the Blue Book on organic nomenclature, which will impact INN naming.
• PMDA (Japan): The Japanese Pharmacopoeia (JP) 16th Supplement was introduced in September 2012, and JAN (Japanese Accepted Names) follow INN rules.
• USP: Has updated its salt naming policy to exclude counter ions and prefixes like di- or tri-.
• WIPO: Appreciates the INN Programme and seeks access to the stem book in the INN data hub for trademark purposes.

Publication and System Improvements

• The Bioreview was updated to include new infixes for gene therapy and a revised rat/mouse category.
• The IDMIS system (INN electronic submission, tracking, and assessment system) was improved, including the establishment of personal folders for experts.

Open Session for Stakeholders

• An open session was held to allow applicants and stakeholders to present their views.
• Celltrion requested the same INN (infliximab) for its biosimilar CT-P13, supported by extensive comparability data.
• EGA emphasized the importance of consistent INN use for biosimilars to maintain market competition and patient access.
• EGA argued that distinct INNs for biosimilars would undermine the non-proprietary nature of INNs and could lead to confusion and interchangeability issues.

Conclusion and Next Steps

• The INN Programme is seen as the best forum for developing a global naming system for biosimilars and cell therapy products.
• The Chair suggested that the Secretariat investigate improvements to the current system and provide guidance to regulatory authorities.
• The 56th Consultation is scheduled for 15–17 April 2013 in Geneva.

Key Recommendations

• Develop a global identifier for biosimilars under WHO guidance.
• Review and update the INNM guidelines to align with IUPAC terminology.
• Explore a descriptive naming system for cell therapy products.
• Improve the IDMIS system and ensure consistent INN application across jurisdictions.
• Maintain the science-based and consistent nature of the INN system.