The terms of approval for every biosimilar and its reference product must be made clearer, argue the European Biopharmaceutical Enterprises (EBE) [1]. The development of biosimilar regulatory pathways worldwide has been led by the European Medicines Agency (EMA) [2], but EMA’s information-driven stepwise approach is only reflected in a single section of the product labelling for healthcare professionals and patients, which so far has followed a generic approach in Europe.
EBE has set out a proposal for transparency concerning evidence generated for these products. A new approach to biosimilar and reference product labelling would ensure more informed clinical use and generate trust in these important medicines.
EBE recommends a combination of information on each biosimilar and its reference product [1]. To achieve this, they argue, greater dialogue is needed between EMA, the Biosimilar Medicinal Products Working Party (BMWP), industry, opinion leaders, and patients.
The Summary of Product Characteristics (SmPC) is the most widely used reference document for physicians. The ‘Guideline on summary of product characteristics’ provides instructions on what needs to be detailed in the SmPC, for all products including biosimilars, but further discussion on detailed specific guidance for biosimilars is needed.
BMWP has discussed the structure of the SmPC in relation to biosimilars. One option they have considered is identical labelling for both the biosimilar and its reference product. Differential product labelling could suggest a difference between the biosimilar and reference product, BMWP noted, potentially leading prescribers to conclude that biosimilars do not require the same level of evidence as their reference products.
EBE acknowledges these concerns, but contend that the SmPC would be better served if it were represented by a combination of information from both the biosimilar and the reference product if the label is different.
Consistency and transparency of biosimilar labels will lead to a better understanding and acceptance of these products with all stakeholders, EBE concludes.
References
1. European Biopharmaceutical Enterprises. Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(4):188-92. doi:10.5639/gabij.2014.0304.043
2. GaBI Online – Generics and Biosimilars Initiative. EU publishes consensus report on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 31]. Available from: www.gabionline.net/Reports/EU-publishes-consensus-report-on-biosimilars
Source: www.gabionline.net
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