EC Targets Biosimilars With Clarifications on Duplicate Marketing Authorizations

Regulatory NewsRegulatory News | 21 May 2018 |  By 

The European Commission late last week sought consultation on proposed clarifications for handling duplicate marketing authorizations (MAs).

As readers of Focus remember from last March (when two Humira (adalimumab) biosimilars were granted duplicate authorizations), the EC is allowed, under certain circumstances, to issue duplicate MAs when issues with existing patents in certain Member States crop up and for other public health reasons.

Requests for duplicate marketing authorisation applications (MAAs) for public health grounds “must be justified by objective verifiable reasons regarding the availability of medicinal products to healthcare professionals and/or patients, as required by Article 82 (1) of Regulation (EC) 726/2004,” the EC said.

The EC also acknowledged the difficulties with such duplicate MAAs, noting “potential issues related to the granting of duplicate marketing authorisations for biological medicinal products on the grounds that they would be a ‘first generic’. These issues relate to 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.”

As part of its clarification, the EC is seeking to add a line to Annex I, section 1 under the regulation, and on the first entry of generics in the case of duplicates of biologicals by adding: “Requests for duplicate marketing authorisation applications need to be properly substantiated and based on sound evidence.”

The EC is also seeking to add a footnote that reads: “On the basis of the experience gained since the publication of the notice, the first introduction of a generic product by the holder of a biological medicinal product may not improve availability. However, 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 the duplicate marketing authorisation on the availability of biosimilars to health care professionals and patients”

Stakeholders are invited to comment on the consultation by 10 September 2018.

Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products


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