Template for Public Assessment Summary Information for Biosimilar (PASIB)
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 acessible 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 a common language, however, may also encourage NRAs who do not currently publish their reviews to engage in this initiative.
The IPRF BWG is providing a number of draft documents to gain initial feedback on the PASIB approach.
The documents at this stage are comprised of a
- template information
- four completed examples:
- Remsima (EMA & MFDS)
- Zarzio (EMA)
- Herzuma (MFDS).
Interested stakeholders are invited to provide feedback during a 2-months consultation period.
Please note that the deadline for comments is 9 May 2016.
Comments should be provided using the contact form below or using the following e-mail address: Secretariat.IPRF@swissmedic.ch