Public Assessment Summary Information for Biosimilar (PASIB) – final documents after consultation

18 August 2016
The IPRF Biosimilars Working Group (IPRF BWG) has proposed the development of a template to assist National Regulatory Authorities (NRA) in making available a summary of the review of biosimilar applications in their country in a common language (e.g. English).

For Authorities who already publish assessment reports following the review of medicinal product applications in their country, these are often in the local language and as a result are not easily accessible to the wider (global) community. The proposed Public Assessment Summary Information for Biosimilar (PASIB) is intended to increase transparency and to facilitate the transition from a local assessment report to one prepared in the English language.

The PASIB includes key information and summarised details of the biosimilar review.
The template and its use has been designed to reduce local translation effort by the NRA to a minimum and recommends that the applicant / sponsor for the biosimilar populate the data parts of the document in English as part of the process.  The NRA maintains responsibility for relevant sections summarizing the review.

The PASIB is an optional tool and may be less relevant for NRAs who already publish assessment reports in English, however, may still be helpful to optimize their current content with the recommendations made in the template information. It is proposed that the first authority to authorize a biosimilar product in a new substance class will prepare a PASIB for publication. Further PASIBs will follow as biosimilars get approved in the various jurisdictions.

The documents are comprised of a

  • template
  • template information
  • four completed examples:
    • Remsima (EMA & MFDS)
    • Zarzio (EMA)
    • Herzuma (MFDS)

 

Title Description Owner Date Size Type Download
Template IPRF – PASIB TEMPLATE (revised) admin08/19/16222KBPDF
Download
Template information IPRF – PASIB – Guide to Completion/Implementation admin08/19/16234KBPDF
Download
PASIB Examples: REMSIMA (European Medicines Agency) IPRF – PASIB – Example 1 admin08/19/16269KBPDF
Download
PASIB Examples: REMSIMA (MFDS) IPRF – PASIB – Example 2 admin08/19/16333KBPDF
Download
PASIB Examples: ZARZIO (European Medicines Agency) IPRF – PASIB – Example 3 admin08/19/16328KBPDF
Download
PASIB Examples: HERZUMA (MFDS) IPRF – PASIB – Example 4 admin08/19/16400KBPDF
Download