Ordinarily only one market authorisation is granted to an applicant for a specific medicinal product, however the applicant/holder can obtain a duplicate authorisation at reduced cost for the same medicinal product where "there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or co-marketing reasons". Holders of a market authorisation for a reference medicinal product have been relying on this exception in Regulation EC No 726/2004 and the examples in the European Commission's 2011 guidance, to obtain a duplicate authorisation for the first generic product on the basis that its inaugural launch into the market can improve availability because it usually increases accessibility.
However, Commission Services has recognised that such duplicate authorisations may have an impact on the biosimilar market (even anti-competitive effects), and may undermine the availability of treatment options for patients.
Interested stakeholders only have until 10 September to comment on the impact of duplicate authorisations of biological medicinal products on the availability of biosimilars to healthcare professionals and patients. Thereafter the Commission shall determine if amendments to the guidance are necessary.
The objective of the targeted stakeholder consultation is to seek the views of interested parties on the specific issue of the impact of duplicate marketing authorisations of biological medicinal products on the availability of biosimilars to healthcare professionals and patients. The results of the targeted stakeholders consultation will allow the Commission to take an informed decision as to whether there is a need to clarify the current wording of Annex I, Section 1 of the note on the handling of duplicate marketing authorisations applications on this particular matter.