IPRF Suggests Global Template for Sharing Biosimilar Assessment Data

The International Pharmaceutical Regulators Forum has come up with a draft template that it says should help national regulatory bodies produce a standardized English-language summary of their assessments of biosimilar medicines¹.

The aim of the exercise is to make it easier for authorities that publish assessment reports only in their local language to prepare one in a format that allows information on the product to be shared more easily with regulatory authorities, industry and other stakeholders at global level.

What the IPRF calls a "Public Assessment Summary Information for Biosimilar" (PASIB) would include key information and summary details of the biosimilar review, including data on the comparability exercise and, where applicable, decisions on extrapolation of indications and interchangeability.

The IPRF says that the PASIB is an optional tool that might be less relevant for national regulatory authorities (NRAs) that already publish assessment reports in English, but that it "may encourage NRAs who do not currently publish their reviews to engage in this initiative." It also suggests that the first regulator to authorize a biosimilar product in a new substance class should prepare a PASIB for publication.

A consultation on the proposal is currently under way, with comments to be in by May 9. To accompany the draft template, the IPRF's biosimilars working group has produced an implementation guide and four completed PASIB examples for Celltrion's Remsima (infliximab) and Herzuma (trastuzumab) and Sandoz' Zarzio (filgrastim) from the European Medicines Agency and the South Korean Ministry of Food and Drug Safety, to illustrate for sponsors and regulators how it would be done. These PASIBS are "of different complexity," it notes.

The PASIB comprises three sections:

• Administrative information. Mainly completed by the applicant, this would contain details of the biosimilar and the reference product, the indications applied for, compliance with legal requirements, and links to additional information published by the national regulator.
• Data submitted and reviewer summary. The dossier and data content part would be filled in by the sponsor, and the review details by the authority. The quality part section would include the identification of analytical methods "at a high level, respecting confidentiality issues."
• Reviewer conclusions. This section would contain concise high-level conclusions to convey the basic information, such as whether the biosimilarity exercise was considered acceptable. It can mention areas where issues were raised during the review, and indicate whether all the claims proposed by the sponsor have been accepted (extrapolation of indications for example). "Sufficient reasoning should be included in the PASIB to convey the outcome to a knowledgeable reader."

A conclusion on the interchangeability of the biosimilar and the reference product is optional, as such a consideration may or may not be within the remit of the NRA. If data on interchangeability are provided, these are included in Section B, while the following sentence may be used in Section C if the NRA has made an assessment of interchangeability: "The NRA has determined that the biosimilar product (trade name) was considered to be interchangeable with the reference biotherapeutic product (trade name)."

Data To Be Included

As a guide to what should be included in the PASIB, the IPRF says that most non-clinical data and all clinical data will be considered suitable for inclusion (although certain assays may be identified only at high level for confidentiality reasons).

It says the aim is not to replicate the detailed assessment of a biosimilar but to condense the key information as far as possible. "This can be achieved in under 10 pages and shorter reports (around six pages) are preferred."

With appropriate (informal) agreement from the sponsor, the national authority may provide a local language assessment to the sponsor for assistance in translation, while the regulator may also complete the whole PASIB document without help from the applicant/sponsor, according to the IPRF.

If a detailed assessment report has not already been (or will not be) published by the national regulator, then a PASIB in the local language may be helpful, although it will be important to ensure that an English language version is also made available, it adds.

While the aim of the PASIB is to achieve a high level of transparency, it is "recognised that different jurisdictions will have their own regulatory framework and may not be able to populate all parts of the PASIB to the same extent," the IPRF says. If certain fields would conflict with the prevailing legislation, the competent authority can state "Confidential – Not Released."

PASIBs should be consistent as far as possible to help in comparisons with assessment reports elsewhere and to avoid "linguistic challenges" during translation. To help in this, certain parts of the template contain standard sentences that can be used more or less as written.

Finalised reports (in English) are expected to be published on the relevant national authority website, with a link to the reports made available on the IPRF website.

The IPRF provides a forum for members to exchange information on issues of mutual concern and regulatory cooperation. It says its aim is to "maximize potential efficiencies in addressing the increasingly complex global context of medicines regulation" and to "facilitate the implementation of ICH [International Council on Harmonization] and other internationally harmonized technical guidelines for pharmaceuticals for human use²."

References

1. Consultation on IPRF Template for Public Assessment Summary Information for Biosimilar (PASIB), www.i-p-r-f.org/index.php/en/news/template-review-biosimilar-applications-consultation-process/
2. IPRF website, www.i-p-r-f.org/index.php/en/iprf-network/mandate/