EC Proposes Changes to Duplicate Marketing Authorizations for Biologics

The European Commission (EC) has announced that it is seeking comments on recently proposed clarifications for how the organization will handle duplicate marketing authorizations (MAs) for biologics.

Currently, the EC operates under its 2011 notice about the handling of duplicate MAs, stating that “only 1 authorization may be granted to an applicant for a specific medicinal product.” However, in the case of extenuating circumstances, such as concerns about public health regarding the availability of the product or co-marketing reasons, the same applicant is allowed to submit more than 1 application for the same product. If a duplicate application is submitted, the 2011 guideline clarifies that the evaluation of the application will be a “case-by-case decision.”

Since the release of its guidance, the EC has identified potential issues in granting duplicate marketing authorizations, namely that a duplicate could be considered a “first generic.” The EC has concerns about the possible impact of duplicate authorizations specifically for the biosimilar market, fearing that it could undermine treatment options available to patients or potentially have anti-competitive effects on the market.

In order to address the potential confusion within the wording of the current guideline, the EC has proposed to add a line that reads, “Requests for duplicate marketing authorization applications need to be properly substantiated and based on sound evidence.”

In addition, the EC is also proposing the inclusion of a footnote within the document that states, “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 authorization on the availability of biosimilars to health care professionals and patients.”

Stakeholders are invited to comment on the proposed changes until September 10, 2018. In the meantime, requests for duplicate marketing authorization applications will be evaluated on a case-by-case basis.