The EMA’s QRD (Quality Review of Documents) guideline governs the format and content of biosimilar labelling, but does not delineate between biosimilars, generics and hybrid products.
The guidance says: “The SmPC [Summary of Product Characteristics] 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.”
But EuropaBio believes that because biosimilars are part of a separate and distinct category of medicinal products and have a different regulatory approval pathway than both originator products and generics in the EU, biosimilars should have different labelling.
The European biosimilar pathway recognises that biosimilars represent “a version of the active substance of an already authorised biological product,” which means there can be minor differences between a reference product and its biosimilar.
EuropaBio is of the opinion that “a reference of” the stepwise approach used to decide whether and to what extent biosimilarity has been achieved, as well as the data generated, should be included in the SmPC and the PIL (Patient Information Leaflet) in order to “contribute to facilitate physicians’ and patients’ understanding and acceptance of biosimilars.”
“The wording in the SmPC should clearly identify by name each product the data were generated with (e.g., the reference product, the biosimilar, or a larger class of products, where there is a class issue). In addition to a brief discussion of the scientific justification for any extrapolation in the SmPC, an in-depth discussion should continue to be included in the European Public Assessment Record (EPAR),” EuropaBio says.
It is of utmost importance that there should not be any disconnect between a biosimilar´s clinical and non-clinical data and the information included in the SmPC. In other words, the SmPC should not misleadingly imply that data generated from the reference product was generated from the biosimilar (or vice versa).
The industry group also cites a comment piece from Nature in 2012 that offers three approaches for labelling biosimilars:
- Biosimilars’ label is an identical copy of the reference product’s label;
- Label only gives information on the biosimilar; and
- Label combines information on both the biosimilar and the reference product.
EuropaBio says it “supports a transparent label which combines information on both the biosimilar and the reference product” and it “calls on European regulators to develop a specific guidance on the labelling of biosimilars and to no longer assign a generic label to biosimilars.”
EuropaBio’s call for action on biosimilar labelling echoes similar calls made by the US biotech industry group BIO on biosimilar names. BIO, along with some physician groups and several industry leaders, says biosimilars should have different names than their reference products so that physicians understand the differences between the products.