The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders. These include entities involved in the development, manufacture and/ or commercialisation of medicinal products for human use, in particular biological medicinal products and biosimilars, patient groups, healthcare professionals as well as insurance and procurement agencies.

The objective of this targeted stakeholder consultation is to collect the views of interested parties on the impact of duplicate marketing authorisations of biological medicinal products on the availability of biosimilars to healthcare professionals and patients.

Annex I of the Note on the handling of duplicate marketing authorisation applications[1], Section 1 regarding “public health reasons” provides that “the first introduction of a generic product by the holder of the reference medicinal product can also improve the availability of a medicinal product. This is because of the first entry of a generic to the market has an impact on availability as it usually increases its accessibility“.

In the EU, companies can apply for a duplicate marketing authorisation in exceptional circumstances. This would include when there are objective, verifiable reasons relating to public health regarding to the availability of medicinal products to healthcare professionals and/or patients or for co-marketing reasons.

The European Commission proposes to update Annex I and add the following sentence: “Requests for duplicate marketing authorisation applications need to be properly substantiated and based on sound evidence“. The European Commission provides that on the basis of the experience gained since the publication of the Note, the first introduction of a biosimilar by the holder of a biological medicinal product may not improve availability. The European Commission provides, however, that a case-by-case assessment of the impact on the availability of the product will be undertaken on the basis of evidence provided by the applicant, with due consideration of the impact of duplicate marketing authorisation on the availability of biosimilars to health care professionals and patients.

Since the publication of the Note on handling of duplicate marketing authorisations applications in 2011, the European Commission Services have identified potential issues with regard to the grant of the duplicate marketing authorisations for biological medicinal products on the grounds that they would be a “first generic”. These issues concern the possible impact of such duplicate marketing authorisations on the biosimilar market (including potential anticompetitive effects) and the undermining of treatment options available to patients.

The stakeholders are invited to comment on this consultation by 10 September 2018 at the latest.