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 EuropaBio Statement on Labelling of Biosimilars

Transparent labelling is important to ensure that physicians and patients have readily available product-specific information about biosimilars, as is the case for originator products. Transparent labelling allows physicians to make informed decisions when ing the most appropriate medicinal product for their patients.

We believe that both the Summary of Product Characteristics1 (SmPC) and the Patient Information Leaflet2 (PIL) should be the primary source of information for physicians and patients. A 2013 survey of the Alliance for Safe Biologic Medicines (ASBM) showed that 86% of EU physicians often use the SmPC to learn about the details of medicines they prescribe, whilst 81% rarely look at the European Public Assessment Report (EPAR).

Taking into account the importance of the SmPC for physicians’ information, we are concerned that the current labelling regime for biosimilars may be insufficient for these products, given their unique scientific and regulatory status. We therefore call for a specific guidance on the labelling of biosimilars.

The current EU approach to labelling does not distinguish between biosimilars and generics

Format and content of labelling is governed by the EMA’s QRD (Quality Review of Documents) guidance3 which does not distinguish between biosimilars, generics and hybrid products. In particular, the QRD guidance states that:

“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”. However, “the applicant should discuss and justify any differences of the proposed SmPC vis-a-vis the SmPC of the reference medicinal product”.

We believe that this approach may be inconsistent with the nature of biosimilars and inappropriate for the following reasons.

Biosimilars’ labelling should reflect biosimilars’ specificities

 From a legal standpoint, biosimilars are recognised as a distinct category of medicinal products and have a different regulatory approval pathway than both originator products and generics in the EU. The European biosimilar pathway recognises that, unlike generic products, a biosimilar product is similar (but not identical) to its reference product as it contains a version of the active substance of an already authorised biological product. Therefore, there can be minor differences between a reference product and its biosimilar(s) as well as among different biosimilars of the same reference product.

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