European Commission tightens requirements for duplicate MAAs

Regulatory NewsRegulatory News | 29 March 2021 |  By 

The European Commission earlier this month issued an updated notice detailing how it handles duplicate marketing authorization applications (MAAs) for pharmaceuticals and biologics, three years after launching a targeted consultation on the practice.
While the notice still foresees an increase in the number of requests for duplicate MAAs, the Commission has closed off the ability of companies to request duplicate MAAs solely to introduce a first generic to their own product.
Typically, the Commission may only grant one authorization to an applicant for a specific medicinal product. However, exceptions to this rule are made in Article 82(1) of Regulation (EC) No 726/2004, which allows the commission to issue duplicate MAAs, “when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons.”
Duplicate MAAs have been issued for both pharmaceuticals and biologics and have sometimes been used by originator companies to market first generics or biosimilar versions of their own products, referred to as autobiologicals.
In 2018, the Commission launched a public consultation specifically looking into whether issuance of duplicate MAAs for autobiologicals “could have anticompetitive effects and undermine other treatment options available to patients.” (RELATED: EC targets biosimilars with clarifications on duplicate marketing authorizations, Regulatory Focus 21 May 2018; EC considers amending provision on duplicate MAAs for biologics, Regulatory Focus 18 November 2019).
Under the previous version of the notice from 2011, the Commission took a favorable view of companies seeking duplicate MAAs when the duplicate application would support first generic entry.
“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 the first entry of a generic to the market has an impact on availability as it usually increases accessibility,” the Commission wrote in its 2011 notice.
However, in the new version of the notice, the Commission reversed its previous stance, writing that, “Experience shows that there is no automatic link between the introduction of a duplicate marketing authorisation by the holder of the original medicinal product (be it a chemical or a biological medicinal product) and increased availability.” The Commission further states that duplicate MAAs can only be granted exceptionally and puts the onus on the authorization holder to demonstrate that a duplicate MAA is likely to increase availability.
The updated notice also features clarifications about the scope of Article 82(1) and includes a template specifying the information applicants must provide when submitting a request for a duplicate MAA.
European Commission


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy