![]() For duplicates (chemical or biologics) requested on the basis of public health reasons the applicant should provide specific evidence with regards to the product in question to allow the Commission to verify a positive effect on availability. “ A duplicate marketing authorisation is an exceptional process. The proposal was to include the following language in the guidance: More importantly, however, the representatives of the EU Member States were invited to comment on proposed revisions to the 2011 Note, which had been prepared by the Commission to table at the meeting. The objective of the discussion at the recent meeting of the Pharmaceutical Committee was to seek updates on the experience of the EU Member States with biological medicinal products placed on their markets on the basis of duplicate marketing authorisations. ![]() Discussion at the Pharmaceutical Committee meeting There have been very differing views expressed by stakeholders about the proposed amendments, which has led to some delay since the end of the consultation in the Commission making proposals for amendment.Īccording to the document now published by the Commission, the competent authorities of nine EU Member States (Belgium, Denmark, Spain, Finland, France, Hungary, the Netherlands, Portugal, Sweden) responded to the public consultation, as well as ten representatives of individual pharmaceutical companies, trade associations, healthcare professionals’ organisations and patient organisations. Companies marketing biosimilars had voiced their concerns that where the first “copy” of the originator’s biological product was marketed by the originator, this did not improve availability of the product, but rather made the marketing of biosimilars less attractive. The objective of the consultation was to seek views on the impact of duplicate authorisations of biological medicinal products on the availability of biosimilars to healthcare professionals and patients. Therefore, between May and September last year, the Commission carried out a public consultation on proposed changes to the 2011 Note. ![]() The 2011 Note does not, however, specifically discuss applications for duplicate marketing authorisation for biological medicinal products. The 2011 Note states that, in principle, the grant on “public health” grounds of a duplicate marketing authorisation for a “first generic” granted to an originator (known as an “authorised generic” in the USA) is possible because of its potentially positive impact on the availability of the medicinal product. In this latter case the Commission has required the applicant to demonstrate that the grant of a duplicate marketing authorisation will result in improved availability of the medicinal product in the EU. As a general principle, the Regulation contemplates the existence of duplicate marketing authorisations only in two situations first, where co-marketing with an independent company is envisaged and secondly “where there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients”. BackgroundĪs we set out in our previous blog, the 2011 Note provides guidance on how the European Commission handles requests for duplicate marketing authorisations submitted through the centralised marketing authorisation procedure in accordance with Article 82.1 of Regulation (EC) No 726/2004 which was motivated by concerns that several MA’s granted for the same product could lead to partitioning of the market. The discussion was intended to be focussed on duplicate marketing authorisations for biological medicinal products and the outcome of the related public consultation that took place in 2018. According to the information published by the Commission, the discussion took place on 7 November 2019 during the latest Pharmaceutical Committee meeting. Earlier this month, the European Commission and representatives of the EU Member States discussed potential revisions to the European Commission’s Note on handling of duplicate marketing authorisation applications (the 2011 Note).
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