Biosimilar SmPC Recommendations

Introduction

This document outlines the proposals put forth by EuropaBio members with regard to small yet meaningful changes to the Summary of Product Characteristics (SmPC) of biosimilars, which we consider would result in an enhanced level of transparency in the label.

EuropaBio advocates that the SmPC of a biosimilar product should contain information and data to facilitate greater transparency to physicians and patients; our position has been recognised in various publications and published on our website. Over the last few years, EuropaBio and its members have taken the opportunity to engage with stakeholders in various forums such as conferences, biosimilar labelling workshops and publications of surveys. EuropaBio recognises that stakeholders would like to understand the nature of the entire data package that has been generated as a basis for approval of Biosimilars. These constructive discussions have allowed EuropaBio to reflect on the changes most pertinent to biosimilar labels and to review the 2012 QRD General Principles regarding the SmPC information for a generic/hybrid/biosimilar product.

In line with this background, we believe that the minor changes to the SmPC proposed in this document will help improve transparency for physicians and patients whilst remaining true to the QRD principles, i.e.:

“[…] the SmPC content for a hybrid or biosimilar medicinal product has to be consistent with the reference medicinal product for the common information applicable to the hybrid or biosimilar product. In other words, the information from the reference medicinal product’s SmPC that applies to the hybrid or biosimilar should be included in the SmPC of the hybrid or biosimilar.

The applicant should discuss and justify any differences of the proposed SmPC vis-à-vis the SmPC of the reference medicinal product.” A review of biosimilar SmPCs, since the first approval in 2006, highlights how they have evolved to become closer to SmPCs used for chemical, small molecule generic drugs. However, it is unclear why this evolution occurred, and it remains to be seen that such an outcome was not the result of inclusive stakeholder discussions.

With this in mind, EuropaBio urges that European and National Competent Authorities continue to engage with all stakeholders to ensure the information and data included in a biosimilar SmPC is appropriate to provide clarity for physicians when prescribing and utilising biosimilar products. Additionally, it remains important that any additional information or data included in the SmPC is still aligned with the principles of QRD template. The minor changes to the SmPC, recommended by EuropaBio in this document, are based on outcomes of stakeholder discussions and various physician, patient and pharmacist surveys, and seek to articulate the issues raised by all these stakeholders.

Download the file below to read all the recommendations.